Rectal CancerT-REXNCT07669298
Active Surveillance vs Adjuvant Chemoradiotherapy for Locally Resected Intermediate-Risk T1 Rectal Cancer
A study testing Active surveillance and Adjuvant chemoradiotherapy in people with Rectal Cancer, run by Medical University of Gdansk at 3 sites in 2 countries.
Trial summary
The goal of this clinical trial is to learn if close follow-up alone (active surveillance) works as well as radiation combined with chemotherapy (chemoradiotherapy) after removing early rectal cancer in adults. The main questions it aims to answer are: 1. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Rectal Cancer
- What is being tested?
- Active surveillance and Adjuvant chemoradiotherapy
- Type of treatment
- Pill or oral medicine, Injection or infusion, Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 480 participants
- Where
- 3 sitesin 2 countries
- Study dates
- 14 Jun 2026to Jun 2037
- Phase
- Interventional
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Pathologically confirmed rectal cancer located extraperitoneally.
- Complete tumour resection (R0) by means of ESD or IMD (endoscopic or TAMIS).
- Pathological report indicative of:
- pT1 with at least 1 of the following features: poor histological differentiation (grade 3), vascular invasion, lymphatic invasion, high tumour budding (grade 2-3), sm2 or sm3 invasion.
- Endoscopic images or video of the tumour before local excision.
- Maximum cancer diameter ≤ 30 mm based on the pathological assessment.
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- cN0 stage based on pelvic MRI; lymph nodes smaller than 10 mm will be considered as benign, independent of morphologic features. Staging must be performed within 6 weeks before randomisation.
- If enlarged lymph nodes are present on MRI performed after ESD/IMD (raising the possibility of reactive inflammatory change), fine needle aspiration (FNA) will be undertaken, and patients with negative FNA cytology will remain eligible.
- Adequate distant staging (thoracic and abdominal CT) without signs of distant metastasis (cM0).
- Have undergone a high-quality full colonoscopy:
- Boston Bowel Preparation Scale score equal or greater than 2 in all colonic segments.
- Documented caecal intubation.
- All polyps ≥20 mm in diameter other than the index lesion must be completely removed and assessed pathologically.
- Expected survival time of more than 12 months from randomisation.
- At least 18 years old at the time of informed consent.
- Eastern Cooperative Oncology Group performance status (ECOG PS) 0, 1 or 2.
- Adequate hematologic function, based upon meeting the following laboratory criteria within 7 days before randomisation:
- Absolute neutrophil count (ANC) ≥ 1.5 × 10^9/L.
- Haemoglobin (Hb) ≥ 8.0 g/dL (red blood cell transfusions are allowed to reach the target level).
- Platelet count ≥ 75 × 10^9/L.
- Adequate liver function, based upon meeting the following criteria within 7 days before randomisation:
- Serum albumin ≥ 3.0 g/dL.
- Total bilirubin (in serum) ≤ 2.0 mg/dL.
- Aspartate aminotransferase (AST) ≤ 3 × the upper limit of normal (ULN).
- Alanine aminotransferase (ALT) ≤ 3× ULN.
- Alkaline phosphatase (ALP) ≤ 3 × ULN.
- Adequate coagulation defined by International Normalized Ratio (INR) ≤ 2.0 within 7 days before randomisation.
- Adequate renal function, based upon meeting the following laboratory criteria within 7 days before randomisation:
- Serum creatinine clearance ≥ 50 mL/min calculated using the Cockcroft-Gault formula.
- Absence of significant proteinuria. If the subject is found to have dipstick test indicative of proteinuria equal or larger than 2+, or lab urinalysis for protein is greater than or equal to 1 g/L, the subject must demonstrate urine protein < 1 g/24 h to be eligible.
- Recovery from prior treatment-related toxicities to < Grade 2 severity per CTCAE v6.0, unless the adverse events are clinically nonsignificant and/or stable on supportive therapy.
- Sexually active fertile subjects and their partners must agree to use medically accepted methods of contraception (e.g., barrier methods, including male condom, female condom, or diaphragm with spermicidal gel) during the study treatment. This does not apply to postmenopausal women (amenorrhoeic for at least 12 consecutive months), women aged above 55, or surgically sterilized patients (men and women).
- Female participants of childbearing potential must not be lactating or pregnant, with a negative beta-human chorionic gonadotropin (beta-hCG) test (blood or urine) at screening and before the first dose of the study treatment.
- Females of childbearing potential are defined as premenopausal females capable of becoming pregnant (i.e., females who have had any evidence of menses in the past 12 months, except for those who had prior hysterectomy). However, women who have been amenorrhoeic for 12 or more months are still considered to be of childbearing potential if the amenorrhea is possibly due to prior chemotherapy, antioestrogens, ovarian suppression, low body weight, or other reasons.
- Written informed consent to participate in the study provided before randomisation.
- Capability of understanding and complying with the protocol requirements.
- Absence of any psychological, familial, sociological or geographical condition potentially hampering compliance with the study protocol and follow-up schedule; those conditions should be discussed with the patient before registration in the trial.
- Eligibility for thoracic, abdominal and pelvic CT and MRI.
Who cannot join
- Suspicion of distant metastases on computed tomography of the abdomen or thorax or lymph node involvement (lymph nodes >9mm in short axis); In case of isolated enlarged nodes biopsy will be required before exclusion.
- Mesorectal tumour involvement on pelvic MRI.
- Synchronous colorectal cancer in screening colonoscopy.
- Known genetic cancer syndrome, including, but not limited to adenomatous or serrated polyposis syndrome; Lynch or Lynch-like syndrome.
- Known inflammatory bowel disease.
- Previously identified allergy or hypersensitivity to 5-FU or capecitabine.
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- Known or suspected dihydropyridine dehydrogenase (DPD) deficiency.
- Prior receipt of pelvic radiation.
- Other contraindications to pelvic irradiation.
- Serious illness other than cancer that would preclude safe participation in the study
- Uncontrolled and significant condition, including, but not limited to, the following conditions:
- Heart failure NYHA II or above.
- Major cardiac arrhythmia.
- Myocardial infarction within 6 months before randomisation.
- Unstable angina pectoris.
- Stroke (including transient ischemic attack, TIA) within 6 months before randomisation.
- Thromboembolism within 3 months before randomisation.
- History of hypertensive crisis.
- Gastrointestinal disorders associated with a high risk of perforation or fistula formation.
- Gastrointestinal bleeding event within 28 days of randomisation.
- Major surgery performed within 4 weeks prior to randomisation or scheduled for surgery during the study period. Complete healing from major surgery must have occurred 1 month before randomisation. Complete healing from minor surgery must have occurred at least 7 days before randomisation.
- Serious non-healing wound or bone fracture.
- Malabsorption syndrome.
- Pregnancy or lactation.
- Mismatch repair deficiency (dMMR) or microsatellite instability-high (MSI-H).
Trial locations and contacts
3 sites in 2 countries. Contact the study team or a site near you to ask about taking part.
3 sites in 2 countries
Poland2 sites, 2 recruiting
- Recruiting
University Clinical Centre
Gdansk, 80210
Piotr Spychalski, MD, PhD, (58) 349 20 00, piotr.spychalski@gumed.edu.pl
Jaroslaw Kobiela, Prof.
- Recruiting
Institute of Oncology in Warsaw
Warsaw
Michal Kaminski, Prof., (22) 546 23 28, michal.kaminski@nio.gov.pl
Michal Kaminski, Prof.
France1 site, 1 recruiting
- Not yet recruiting
University Hospital, Limoges
Limoges
Jeremie Jacques, Prof., 05 55 05 87 72, josette.rebours@chu-limoges.fr
Jeremie Jacques, Prof.
About this study
Official title: Active Surveillance vs Adjuvant Chemoradiotherapy for Locally Resected Intermediate-Risk T1 Rectal Cancer: Multicentre Randomised Controlled Trial
The goal of this clinical trial is to learn if close follow-up alone (active surveillance) works as well as radiation combined with chemotherapy (chemoradiotherapy) after removing early rectal cancer in adults. The main questions it aims to answer are:
- Does active surveillance cause fewer serious adverse events than chemoradiotherapy within 3 years? Serious adverse events include a permanent or temporary ostomy (a surgical opening in the belly to pass stool), major bowel problems, or severe treatment-related complications.
- Is active surveillance as safe as chemoradiotherapy in preventing cancer from coming back or spreading within 3 years?
Read more
Researchers will compare active surveillance to chemoradiotherapy to see if surveillance causes fewer serious adverse events while keeping cancer outcomes comparable.
To join this study, participants must be adults who had an early-stage rectal cancer (T1) removed by an endoscopic procedure, and whose removed tumor showed certain features that raise the risk of cancer cells remaining nearby.
Participants will be randomly placed in one of two groups:
- Active surveillance group: Participants will have regular checkups, blood tests, flexible camera exams of the bowel (rectoscopy), scans of the pelvis and abdomen, and colonoscopy on a set schedule for 5 years. If cancer comes back, doctors will propose further treatment options.
- Chemoradiotherapy group: Participants will receive radiation to the pelvis along with a chemotherapy pill (capecitabine) or an intravenous (IV) chemotherapy drug (5-FU) for about 5 weeks. After treatment, they will have regular checkups and scans for 5 years.
Read the detailed description
The current standard treatment for T1 rectal cancer (T1N0M0) is local excision by endoscopic submucosal dissection (ESD) or intermuscular dissection (IMD) performed endoscopically or via transanal minimally invasive surgery (TAMIS). More than half of the patients treated with ESD or IMD require secondary treatment due to unfavourable histopathological features in the resected specimen. Lesions can be classified as intermediate-risk if the specimen presents at least one of the following features: poor differentiation (grade 3), lymphovascular invasion, high-grade tumour budding (grade 2-3), or deep submucosal invasion (sm2-sm3).
Secondary treatment can be performed either by total mesorectal excision (TME) or adjuvant chemoradiotherapy. The latest evidence suggests that chemoradiotherapy may offer a superior risk-benefit ratio compared to completion TME. Still, chemoradiotherapy remains associated with a substantial risk of major low anterior resection syndrome (LARS); the risk is reduced but still reported at approximately 25-33%. Given a 15-20% risk of lymph node involvement in the intermediate-risk group, chemoradiotherapy might be overtreatment for the majority of these patients. Active surveillance can reduce treatment-related morbidity, but it is associated with higher local recurrence rates. Available cohort data suggest that most recurrences are detected early during structured surveillance and are salvageable with curative-intent surgery, resulting in oncological outcomes similar to those achieved with adjuvant chemoradiotherapy. However, no randomised trial has directly compared these two strategies in this population.
- Conditions
- Rectal Cancer
- Being tested
- Active surveillance, Adjuvant chemoradiotherapy
- Keywords
- early rectal cancer, local excision, active surveillance, adjuvant chemoradiotherapy, organ preservation
- Medical subject headings
- Rectal Neoplasms
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Active surveillanceOther
Active surveillance includes physical examination, and carcinoembryonic antigen (CEA) testing every 3 months during years 1-2 and every 6 months during years 3-5. Rectoscopy is performed every 3 months during years 1-2 and every 6 months during years 3-5. Pelvic MRI is performed every 6 months for 5 years. Thoracic and abdominal CT scans are performed annually for 5 years. Colonoscopy is performed at 1 year after local excision and subsequently according to findings. Recurrences are managed according to multidisciplinary team recommendations.
Adjuvant chemoradiotherapyRadiation
Adjuvant long-course pelvic chemoradiotherapy will be initiated within 12 weeks after local excision. Radiotherapy consists of 45 Gy delivered in 25 fractions of 1.8 Gy once daily, 5 days per week, over approximately 5 weeks. Concurrent chemotherapy consists of either oral capecitabine 825 mg/m² twice daily on radiotherapy days or continuous intravenous 5-fluorouracil 225 mg/m²/day throughout radiotherapy. After treatment, follow-up includes history, physical examination, CEA testing, and flexible sigmoidoscopy every 6 months for 5 years; pelvic MRI every 6 months during the first 3 years; annual thoracic and abdominal CT for 5 years; pelvic CT after discontinuation of MRI surveillance; and colonoscopy at 1 year and thereafter according to findings.
| Study group | Role | What they receive |
|---|---|---|
| Active surveillance | Experimental | Not described Receives: Other: Active surveillance |
| Adjuvant chemoradiotherapy | Active comparator | Not described Receives: Radiation: Adjuvant chemoradiotherapy |
What is being measured
The primary outcome is the main question the study is designed to answer.
Disease-related treatment failure
Time from randomisation to the first occurrence of:
- Cancer specific death.
- Non-salvageable locoregional recurrence.
- Distant metastases.
Measured: 3 years from randomisation
Composite severe treatment-related adverse event
Occurrence of any of the following:
- Stoma (permanent or temporary).
- Major LARS (score ≥30).
- CTCAE grade ≥3 toxicity.
- Clavien-Dindo ≥3b complications.
Measured: 3 years from randomisation
Secondary outcomes (14)
Disease-free survival
Time from randomisation to first event: death (any cause), distant metastases, or locoregional recurrence
Measured: 3 and 5 years after randomization
Overall Survival
Time from randomization to death from any cause.
Measured: 3 and 5 years after randomization
Stoma formation rate
Proportion of patients with a colostomy or ileostomy (permanent or temporary) present at assessment. Stoma rates will be evaluated at predefined follow-up intervals.
Measured: 12 months, 3 years, and 5 years after randomization
Incidence of Major Low Anterior Resection Syndrome (LARS)
Proportion of patients with a LARS Questionnaire score of 30 points or greater, indicating major low anterior resection syndrome.
Measured: 12 months, 3 years, and 5 years after treatment
Grade 3 or Higher Treatment-Related Toxicity
Incidence of adverse events of grade 3 or higher according to Common Terminology Criteria for Adverse Events (CTCAE) version 6.0 occurring during treatment and follow-up.
Measured: From treatment initiation through 12 months after completion of chemoradiotherapy.
Locoregional Recurrence Rate
Proportion of patients with radiologically or histologically confirmed recurrence within the pelvis or mesorectum.
Measured: 5 years after randomization.
Salvageability of Locoregional Recurrence
Proportion of detected locoregional recurrences amenable to curative-intent salvage therapy.
Measured: At the time of recurrence detection, up to 5 years after randomization
Duration of Hospital Stay After Primary Treatment
Total cumulative length of hospitalization following the randomized treatment strategy, measured in calendar days.
Measured: From the day of randomization untill 5 years from randomization.
Distant Recurrence Rate
Proportion of patients with radiologically or histologically confirmed distant metastatic disease outside the locoregional area.
Measured: 3 years and 5 years after randomization.
Health-Related Quality of Life (EORTC QLQ-C30)
Health-related quality of life assessed using the European Organisation for Research and Treatment of Cancer Quality of Life Questionnaire - Core 30 (EORTC QLQ-C30).
Measured: Baseline, 12 months, 3 years, and 5 years after randomization
Healthcare Resource Utilization Costs per Patient
Direct healthcare resource utilization costs including treatment, procedures, imaging, hospitalization, surveillance, and management of recurrence and complications measured as a total per patient in euro (€).
Measured: Up to 5 years after randomization.
Cost-Effectiveness
Incremental cost-effectiveness expressed as cost per quality-adjusted life-year (QALY) gained and cost per disease-free survival year gained.
Measured: 3 years and 5 years after randomization
Ostomy-Free Survival
Time from randomization to permanent ostomy formation or death, with estimation of the proportion of patients alive without a permanent ostomy.
Measured: 3 years and 5 years after randomization.
Health-Related Quality of Life (EORTC QLQ-CR29)
Health-related quality of life assessed using the European Organisation for Research and Treatment of Cancer Quality of Life Questionnaire - Colorectal Cancer Module (EORTC QLQ-CR29).
Measured: Baseline, 12 months, 3 years, and 5 years after randomization.
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted25 Jun 2026
- Study start14 Jun 2026
- Primary completionJun 2037 (estimated)
- Study completionJun 2037 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (8)Papers the sponsor has linked to this study.
- Other trials for Rectal CancerStudies of the same condition, open and under way.
- More trials run by Medical University of GdanskThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 480 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Medical University of Gdansk
- Sponsor type
- University, hospital or other
- Collaborators
- University of Oslo, Maria Sklodowska-Curie National Research Institute of Oncology, Centre Hospitalier Universitaire Dupuytren de Limoges (CHUL), Vestre Viken Hospital Trust, Universitätsklinikum Hamburg-Eppendorf, Karolinska Institutet, University Hospital, Akershus, University of Roma La Sapienza, Hospital Clinic of Barcelona, Leuven University Medical Center, University Hospital, Ghent, Sorlandet Hospital HF, Northern Norway Regional Health Trust, Helse Stavanger HF, Haukeland University Hospital, St. Olavs Hospital
- Responsible party
- Principal investigator, Michał F.Kaminski, Medical University of Gdansk
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07669298
- Sponsor's protocol ID
- KB/247/2026
- Other IDs
- 101156165
- Acronym
- T-REX
- Status last verified
- Jun 2026
- First submitted
- 16 Jun 2026
- Last updated
- 25 Jun 2026
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
Publications
van Oostendorp SE, Smits LJH, Vroom Y, Detering R, Heymans MW, Moons LMG, Tanis PJ, de Graaf EJR, Cunningham C, Denost Q, Kusters M, Tuynman JB. Local recurrence after local excision of early rectal cancer: a meta-analysis of completion TME, adjuvant (chemo)radiation, or no additional treatment. Br J Surg. 2020 Dec;107(13):1719-1730. doi: 10.1002/bjs.12040. Epub 2020 Sep 16.
PubMed 32936943Ouchi A, Komori K, Masahiro T, Toriyama K, Kajiwara Y, Oka S, Fukunaga Y, Hotta K, Ikematsu H, Tsukamoto S, Nagata S, Yamada K, Konno M, Ishihara S, Saitoh Y, Matsuda K, Togashi K, Ishiguro M, Kuwai T, Okuyama T, Ohuchi A, Ohnuma S, Sakamoto K, Sugai T, Katsumata K, Matsushita HO, Nakai K, Uraoka T, Akimoto N, Kobayashi H, Ajioka Y, Sugihara K, Ueno H; Study Group for the JSCCR-T study. How Does Omitting Additional Surgery After Local Excision Affect the Prognostic Outcome of Patients With High-risk T1 Colorectal Cancer? Ann Surg. 2024 Feb 1;279(2):290-296. doi: 10.1097/SLA.0000000000006092. Epub 2023 Sep 5.
PubMed 37669045Corre F, Albouys J, Tran VT, Lepilliez V, Ratone JP, Coron E, Lambin T, Rahmi G, Karsenti D, Canard JM, Chabrun E, Camus M, Wallenhorst T, Chevaux JB, Schaefer M, Gerard R, Rouquette A, Terris B, Coriat R, Jacques J, Barret M, Pioche M, Chaussade S, Cappelle E. Impact of surgery after endoscopically resected high-risk T1 colorectal cancer: results of an emulated target trial. Gastrointest Endosc. 2024 Mar;99(3):408-416.e2. doi: 10.1016/j.gie.2023.09.027. Epub 2023 Oct 2.
PubMed 37793506Emmertsen KJ, Laurberg S. Low anterior resection syndrome score: development and validation of a symptom-based scoring system for bowel dysfunction after low anterior resection for rectal cancer. Ann Surg. 2012 May;255(5):922-8. doi: 10.1097/SLA.0b013e31824f1c21.
PubMed 22504191Moolenaar LR, van Geffen EGM, Hazen SJA, Sluckin TC, Beets GL, Leijtens JWA, Talsma AK, de Wilt JHW, Tanis PJ, Kusters M, Hompes R, Tuynman JB; Dutch Snapshot Research Group; Collaborators Snapshot Registry. Salvageable locoregional recurrence and stoma rate after local excision of pT1-2 rectal cancer - A nationwide cross-sectional cohort study. Eur J Surg Oncol. 2025 Jun;51(6):109623. doi: 10.1016/j.ejso.2025.109623. Epub 2025 Jan 23.
PubMed 40009914Serra-Aracil X, Pericay C, Cidoncha A, Badia-Closa J, Golda T, Kreisler E, Hernandez P, Targarona E, Borda-Arrizabalaga N, Reina A, Delgado S, Espin-Bassany E, Caro-Tarrago A, Gallego-Plazas J, Pascual M, Alvarez-Laso C, Guadalajara-Labajo H, Otero A, Biondo S; TAUTEM Collaborative Group. Chemoradiotherapy and Local Excision vs Total Mesorectal Excision in T2-T3ab, N0, M0 Rectal Cancer: The TAUTEM Randomized Clinical Trial. JAMA Surg. 2025 Jul 1;160(7):783-793. doi: 10.1001/jamasurg.2025.1398.
PubMed 40434784van der Schee L, Albers SC, Didden P, Lacle MM, Farina Sarasqueta A, Richir MC, Intven MPW, Tuynman JB, Hompes R, Dekker E, Vleggaar FP, Bastiaansen BAJ, Moons LMG. Results of endoscopic intermuscular dissection for deep submucosal invasive rectal cancer: a three-year follow-up study. Gut. 2025 Nov 10;74(12):1995-2003. doi: 10.1136/gutjnl-2024-334612.
PubMed 40562523Moolenaar LR, Ali M, Aufenacker TJ, Beets GL, Bosker RJI, Buffart TE, Burger JW, Dekker E, Denost Q, Doornebosch PG, Duijvendijk PV, Fabry HFJ, Geijsen ED, Gerhards MF, van Grevenstein WMU, Grotenhuis BA, Hoff C, Leijtens JWA, Peeters KCMJ, Pronk A, van der Schelling GP, Sietses C, Smits AB, Toorenvliet BR, van de Ven AWH, Verdaasdonk EGG, Vuylsteke RJCLM, van Westreenen HL, de Wilt JHW, Zimmerman DDE, Lange MM, van Grieken NCT, Bastiaansen BAJ, Hompes R, Marijnen CA, Dijkgraaf MGW, Moons LMG, Tanis PJ, Cunningham C, Tuynman JB; TESAR Study Group. Adjuvant chemoradiotherapy versus completion total mesorectal excision after local excision for early rectal cancer (TESAR): a multicentre, randomised, controlled, phase 3, non-inferiority trial. Lancet Gastroenterol Hepatol. 2026 Jul;11(7):557-569. doi: 10.1016/S2468-1253(26)00109-3. Epub 2026 May 27.
PubMed 42202843
Study at a glance
From the registry record, last updated by the sponsor on 25 Jun 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Active Surveillance vs Adjuvant Chemoradiotherapy for Locally Resected Intermediate-Risk T1 Rectal Cancer: Multicentre Randomised Controlled Trial
- ClinicalTrials.gov ID
- NCT07669298
- Acronym / sponsor ID
- T-REX / KB/247/2026
- Conditions
- Rectal Cancer
- Keywords
- early rectal cancer, local excision, active surveillance, adjuvant chemoradiotherapy, organ preservation
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 480 participants (estimated)
- Lead sponsor
- Medical University of GdanskUniversity, hospital or other
- Collaborators
- University of Oslo, Maria Sklodowska-Curie National Research Institute of Oncology, Centre Hospitalier Universitaire Dupuytren de Limoges (CHUL), Vestre Viken Hospital Trust, Universitätsklinikum Hamburg-Eppendorf, Karolinska Institutet, University Hospital, Akershus, University of Roma La Sapienza, Hospital Clinic of Barcelona, Leuven University Medical Center, University Hospital, Ghent, Sorlandet Hospital HF, Northern Norway Regional Health Trust, Helse Stavanger HF, Haukeland University Hospital, St. Olavs Hospital
- Study start
- 14 Jun 2026 (actual)
- Primary completion
- Jun 2037 (estimated)
- Study completion
- Jun 2037 (estimated)
- First posted
- 25 Jun 2026 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
The goal of this clinical trial is to learn if close follow-up alone (active surveillance) works as well as radiation combined with chemotherapy (chemoradiotherapy) after removing early rectal cancer in adults. The main questions it aims to answer are:
- Does active surveillance cause fewer serious adverse events than chemoradiotherapy within 3 years? Serious adverse events include a permanent or temporary ostomy (a surgical opening in the belly to pass stool), major bowel problems, or severe treatment-related complications.
- Is active surveillance as safe as chemoradiotherapy in preventing cancer from coming back or spreading within 3 years?
Researchers will compare active surveillance to chemoradiotherapy to see if surveillance causes fewer serious adverse events while keeping cancer outcomes comparable.
To join this study, participants must be adults who had an early-stage rectal cancer (T1) removed by an endoscopic procedure, and whose removed tumor showed certain features that raise the risk of cancer cells remaining nearby.
Participants will be randomly placed in one of two groups:
- Active surveillance group: Participants will have regular checkups, blood tests, flexible camera exams of the bowel (rectoscopy), scans of the pelvis and abdomen, and colonoscopy on a set schedule for 5 years. If cancer comes back, doctors will propose further treatment options.
- Chemoradiotherapy group: Participants will receive radiation to the pelvis along with a chemotherapy pill (capecitabine) or an intravenous (IV) chemotherapy drug (5-FU) for about 5 weeks. After treatment, they will have regular checkups and scans for 5 years.
Detailed description
The current standard treatment for T1 rectal cancer (T1N0M0) is local excision by endoscopic submucosal dissection (ESD) or intermuscular dissection (IMD) performed endoscopically or via transanal minimally invasive surgery (TAMIS). More than half of the patients treated with ESD or IMD require secondary treatment due to unfavourable histopathological features in the resected specimen. Lesions can be classified as intermediate-risk if the specimen presents at least one of the following features: poor differentiation (grade 3), lymphovascular invasion, high-grade tumour budding (grade 2-3), or deep submucosal invasion (sm2-sm3).
Secondary treatment can be performed either by total mesorectal excision (TME) or adjuvant chemoradiotherapy. The latest evidence suggests that chemoradiotherapy may offer a superior risk-benefit ratio compared to completion TME. Still, chemoradiotherapy remains associated with a substantial risk of major low anterior resection syndrome (LARS); the risk is reduced but still reported at approximately 25-33%. Given a 15-20% risk of lymph node involvement in the intermediate-risk group, chemoradiotherapy might be overtreatment for the majority of these patients. Active surveillance can reduce treatment-related morbidity, but it is associated with higher local recurrence rates. Available cohort data suggest that most recurrences are detected early during structured surveillance and are salvageable with curative-intent surgery, resulting in oncological outcomes similar to those achieved with adjuvant chemoradiotherapy. However, no randomised trial has directly compared these two strategies in this population.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Active surveillance | Experimental | Other: Active surveillance |
| Adjuvant chemoradiotherapy | Active comparator | Radiation: Adjuvant chemoradiotherapy |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (38 listed)
- Pathologically confirmed rectal cancer located extraperitoneally.
- Complete tumour resection (R0) by means of ESD or IMD (endoscopic or TAMIS).
- Pathological report indicative of:
- Endoscopic images or video of the tumour before local excision.
- Maximum cancer diameter ≤ 30 mm based on the pathological assessment.
Key exclusion criteria (25 listed)
- Suspicion of distant metastases on computed tomography of the abdomen or thorax or lymph node involvement (lymph nodes >9mm in short axis); In case of isolated enlarged nodes biopsy will be required before exclusion.
- Mesorectal tumour involvement on pelvic MRI.
- Synchronous colorectal cancer in screening colonoscopy.
- Known genetic cancer syndrome, including, but not limited to adenomatous or serrated polyposis syndrome; Lynch or Lynch-like syndrome.
- Known inflammatory bowel disease.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Active surveillanceActive surveillance includes physical examination, and carcinoembryonic antigen (CEA) testing every 3 months during years 1-2 and every 6 months during years 3-5. Rectoscopy is performed every 3 months during years 1-2 and every 6 months during years 3-5. Pelvic MRI is performed every 6 months for 5 years. Thoracic and abdominal CT scans are performed annually for 5 years. Colonoscopy is performed at 1 year after local excision and subsequently according to findings. Recurrences are managed according to multidisciplinary team recommendations. | Other | Active surveillance |
| Adjuvant chemoradiotherapyAdjuvant long-course pelvic chemoradiotherapy will be initiated within 12 weeks after local excision. Radiotherapy consists of 45 Gy delivered in 25 fractions of 1.8 Gy once daily, 5 days per week, over approximately 5 weeks. Concurrent chemotherapy consists of either oral capecitabine 825 mg/m² twice daily on radiotherapy days or continuous intravenous 5-fluorouracil 225 mg/m²/day throughout radiotherapy. After treatment, follow-up includes history, physical examination, CEA testing, and flexible sigmoidoscopy every 6 months for 5 years; pelvic MRI every 6 months during the first 3 years; annual thoracic and abdominal CT for 5 years; pelvic CT after discontinuation of MRI surveillance; and colonoscopy at 1 year and thereafter according to findings. | Radiation | Adjuvant chemoradiotherapy |
Primary outcome
Disease-related treatment failure
Time frame: 3 years from randomisation
Time from randomisation to the first occurrence of: 1. Cancer specific death. 2. Non-salvageable locoregional recurrence. 3. Distant metastases.
Composite severe treatment-related adverse event
Time frame: 3 years from randomisation
Occurrence of any of the following: 1. Stoma (permanent or temporary). 2. Major LARS (score ≥30). 3. CTCAE grade ≥3 toxicity. 4. Clavien-Dindo ≥3b complications.
14 secondary outcomes
Disease-free survival
Time frame: 3 and 5 years after randomization
Overall Survival
Time frame: 3 and 5 years after randomization
Stoma formation rate
Time frame: 12 months, 3 years, and 5 years after randomization
Incidence of Major Low Anterior Resection Syndrome (LARS)
Time frame: 12 months, 3 years, and 5 years after treatment
Grade 3 or Higher Treatment-Related Toxicity
Time frame: From treatment initiation through 12 months after completion of chemoradiotherapy.
Locoregional Recurrence Rate
Time frame: 5 years after randomization.
Salvageability of Locoregional Recurrence
Time frame: At the time of recurrence detection, up to 5 years after randomization
Duration of Hospital Stay After Primary Treatment
Time frame: From the day of randomization untill 5 years from randomization.
Distant Recurrence Rate
Time frame: 3 years and 5 years after randomization.
Health-Related Quality of Life (EORTC QLQ-C30)
Time frame: Baseline, 12 months, 3 years, and 5 years after randomization
Healthcare Resource Utilization Costs per Patient
Time frame: Up to 5 years after randomization.
Cost-Effectiveness
Time frame: 3 years and 5 years after randomization
Ostomy-Free Survival
Time frame: 3 years and 5 years after randomization.
Health-Related Quality of Life (EORTC QLQ-CR29)
Time frame: Baseline, 12 months, 3 years, and 5 years after randomization.
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 25 Jun 2026.
- Background: PubMed 32936943van Oostendorp SE, Smits LJH, Vroom Y, Detering R, Heymans MW, Moons LMG, Tanis PJ, de Graaf EJR, Cunningham C, Denost Q, Kusters M, Tuynman JB. Local recurrence after local excision of early rectal cancer: a meta-analysis of completion TME, adjuvant (chemo)radiation, or no additional treatment. Br J Surg. 2020 Dec;107(13):1719-1730. doi: 10.1002/bjs.12040. Epub 2020 Sep 16.
- Background: PubMed 37669045Ouchi A, Komori K, Masahiro T, Toriyama K, Kajiwara Y, Oka S, Fukunaga Y, Hotta K, Ikematsu H, Tsukamoto S, Nagata S, Yamada K, Konno M, Ishihara S, Saitoh Y, Matsuda K, Togashi K, Ishiguro M, Kuwai T, Okuyama T, Ohuchi A, Ohnuma S, Sakamoto K, Sugai T, Katsumata K, Matsushita HO, Nakai K, Uraoka T, Akimoto N, Kobayashi H, Ajioka Y, Sugihara K, Ueno H; Study Group for the JSCCR-T study. How Does Omitting Additional Surgery After Local Excision Affect the Prognostic Outcome of Patients With High-risk T1 Colorectal Cancer? Ann Surg. 2024 Feb 1;279(2):290-296. doi: 10.1097/SLA.0000000000006092. Epub 2023 Sep 5.
- Background: PubMed 37793506Corre F, Albouys J, Tran VT, Lepilliez V, Ratone JP, Coron E, Lambin T, Rahmi G, Karsenti D, Canard JM, Chabrun E, Camus M, Wallenhorst T, Chevaux JB, Schaefer M, Gerard R, Rouquette A, Terris B, Coriat R, Jacques J, Barret M, Pioche M, Chaussade S, Cappelle E. Impact of surgery after endoscopically resected high-risk T1 colorectal cancer: results of an emulated target trial. Gastrointest Endosc. 2024 Mar;99(3):408-416.e2. doi: 10.1016/j.gie.2023.09.027. Epub 2023 Oct 2.
- Background: PubMed 22504191Emmertsen KJ, Laurberg S. Low anterior resection syndrome score: development and validation of a symptom-based scoring system for bowel dysfunction after low anterior resection for rectal cancer. Ann Surg. 2012 May;255(5):922-8. doi: 10.1097/SLA.0b013e31824f1c21.
- Background: PubMed 40009914Moolenaar LR, van Geffen EGM, Hazen SJA, Sluckin TC, Beets GL, Leijtens JWA, Talsma AK, de Wilt JHW, Tanis PJ, Kusters M, Hompes R, Tuynman JB; Dutch Snapshot Research Group; Collaborators Snapshot Registry. Salvageable locoregional recurrence and stoma rate after local excision of pT1-2 rectal cancer - A nationwide cross-sectional cohort study. Eur J Surg Oncol. 2025 Jun;51(6):109623. doi: 10.1016/j.ejso.2025.109623. Epub 2025 Jan 23.
- Background: PubMed 40434784Serra-Aracil X, Pericay C, Cidoncha A, Badia-Closa J, Golda T, Kreisler E, Hernandez P, Targarona E, Borda-Arrizabalaga N, Reina A, Delgado S, Espin-Bassany E, Caro-Tarrago A, Gallego-Plazas J, Pascual M, Alvarez-Laso C, Guadalajara-Labajo H, Otero A, Biondo S; TAUTEM Collaborative Group. Chemoradiotherapy and Local Excision vs Total Mesorectal Excision in T2-T3ab, N0, M0 Rectal Cancer: The TAUTEM Randomized Clinical Trial. JAMA Surg. 2025 Jul 1;160(7):783-793. doi: 10.1001/jamasurg.2025.1398.
- Background: PubMed 40562523van der Schee L, Albers SC, Didden P, Lacle MM, Farina Sarasqueta A, Richir MC, Intven MPW, Tuynman JB, Hompes R, Dekker E, Vleggaar FP, Bastiaansen BAJ, Moons LMG. Results of endoscopic intermuscular dissection for deep submucosal invasive rectal cancer: a three-year follow-up study. Gut. 2025 Nov 10;74(12):1995-2003. doi: 10.1136/gutjnl-2024-334612.
- Background: PubMed 42202843Moolenaar LR, Ali M, Aufenacker TJ, Beets GL, Bosker RJI, Buffart TE, Burger JW, Dekker E, Denost Q, Doornebosch PG, Duijvendijk PV, Fabry HFJ, Geijsen ED, Gerhards MF, van Grevenstein WMU, Grotenhuis BA, Hoff C, Leijtens JWA, Peeters KCMJ, Pronk A, van der Schelling GP, Sietses C, Smits AB, Toorenvliet BR, van de Ven AWH, Verdaasdonk EGG, Vuylsteke RJCLM, van Westreenen HL, de Wilt JHW, Zimmerman DDE, Lange MM, van Grieken NCT, Bastiaansen BAJ, Hompes R, Marijnen CA, Dijkgraaf MGW, Moons LMG, Tanis PJ, Cunningham C, Tuynman JB; TESAR Study Group. Adjuvant chemoradiotherapy versus completion total mesorectal excision after local excision for early rectal cancer (TESAR): a multicentre, randomised, controlled, phase 3, non-inferiority trial. Lancet Gastroenterol Hepatol. 2026 Jul;11(7):557-569. doi: 10.1016/S2468-1253(26)00109-3. Epub 2026 May 27.
- Related InfoLink provided by the sponsor.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
3 sites in 2 countries: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Active surveillance and Adjuvant chemoradiotherapy in people with Rectal Cancer, run by Medical University of Gdansk at 3 sites in 2 countries.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 38 inclusion and 25 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: looking for participants now, as of the sponsor's last update on 25 Jun 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 3 sites in Poland, France. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Michal Kaminski, Prof. ((22) 546 23 28, michal.kaminski@nio.gov.pl), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Disease-related treatment failure (time frame: 3 years from randomisation). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT07669298, which also lists 8 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 25 Jun 2026.