Rectal CancerPhase 3TESARNCT02371304
Rectal Preserving Treatment for Early Rectal Cancer. A Multi-centred Randomised Trial of Radical Surgery Versus Adjuvant Chemoradiotherapy After Local Excision for Early Rectal Cancers
A Phase 3 study testing Adjuvant chemoradiotherapy, Additional TME surgery and capecitabine in people with Rectal Cancer, run by Amsterdam UMC, location VUmc at 1 site in Netherlands.
Trial summary
Current therapy for early colorectal cancer is radical Total Mesorectal Excision (TME). Colorectal surgical resections are accompanied with high morbidity of up to 33% and 90 days mortality of up to 9% in the fragile elderly patients as is seen in the results of the Dutch Surgical Colorectal Audit (DSCA) of 2013. 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?
- Adjuvant chemoradiotherapy, Additional TME surgery and capecitabine
- Type of treatment
- Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 302 participants
- Where
- 1 siteNetherlands
- Study dates
- Oct 2015to Jan 2023
- Phase
- Phase 3
- Are there results?
- None posted in the registry
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
- Patient has had an endoluminal local excision (by TEM, TAMIS, TSPM, EMR/ESD or polypectomy) of an early rectal cancer without carcinoma in the resection plane.
- Patients with carcinoma in the resection plane or in case of unreliable resection planes (EMR/ESD) no macroscopic residual tumour confirmed by endoscopy are eligible for randomisation.
- Only lesions for which TME surgery is indicated can be included (if a partial mesorectal excision (PME) is indicated the patient should be excluded).
- Pathological confirmation of the rectal adenocarcinoma fulfilling the following criteria: T1 with size 3-5 cm of carcinoma or pT1, maximum size of carcinoma of 3 cm, with at least poor differentiation, Haggit 4 and/or sm3, lymphatic and/or venous invasion.
- Pathological confirmation of the rectal adenocarcinoma fulfilling the following criteria: pT2, maximum size of carcinoma of 3 cm, well/moderate differentiated and without lymphatic or venous invasion.
- Complete colonoscopy, without synchronous colorectal cancer.
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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 done within 6 weeks before randomisation.
- Adequate distant staging (X-thorax or CT-thorax and CT-abdomen) without signs of distant metastasis (cM0).
- Male or female, Age > 18 years.
- Life expectancy of at least 12 months.
- Medically fit (WHO 0-2) to undergo radical surgery and/or radiation.
- No contraindications to chemotherapy, including adequate blood counts;
- white blood count >= 4.0 x 10 9/l
- platelet count >=100 x 109/l
- clinical acceptable haemoglobin levels
- bilirubin < 35 umol/l
- creatinine levels indicating renal clearance of >=50 ml/min
- The patient is willing and able to comply with the protocol for the duration of the study, and scheduled follow-up visits and examinations.
- Written (signed and dated) informed consent and be capable of co-operating with protocol.
Who cannot join
- Incomplete or inconclusive resection margin with macroscopic residual tumour.
- T1 tumour with carcinoma < 3 cm, moderate/well differentiated, without sm3, venous or lymphatic invasion.
- T1 tumour with carcinoma of >5 cm and T2 tumour with carcinoma of > 3 cm.
- Presence of metastatic disease or recurrent rectal tumour.
- Previous pelvic radiation.
- Treatment with any other investigational agent, or participation in another clinical trial within 28 days prior to enrolment.
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- Concomitant malignancies, except for adequately treated basocellular carcinoma of the skin or in situ carcinoma of the cervix uteri. Subjects with prior malignancies must be disease-free for at least 5 years.
- Pregnancy, breast-feeding or fertile women without active birth control.
- Clinically significant (i.e. active) cardiovascular disease for example cerebro vascular accidents (<6 months prior to randomization), myocardial infarction (<6 months prior to randomization), unstable angina, New York Heart Association (NYHA) grade II or higher, congestive heart failure, serious cardiac arrhythmia requiring medication.
- Patients who are known to be serologically positive for Hepatitis B, Hepatitis C or HIV.
- History of severe and unexpected reactions to fluoropyrimidine therapy.
- Hypersensitivity to capecitabine.
- Patients with severe hepatic impairment.
- Medical or psychiatric conditions that compromise the patient's ability to give informed consent.
- Patients known with dihydropyrimidine dehydrogenase deficiency
- Any contra-indications to undergo MRI imaging.
Trial locations and contacts
1 site in 1 country.
Lisanne Smits contact
Jurriaan Tuynman contact
Netherlands1 site, 1 recruiting
- Recruiting
VU University Medical Center
Amsterdam
J.B. Tuynman, surgeon
About this study
Current therapy for early colorectal cancer is radical Total Mesorectal Excision (TME). Colorectal surgical resections are accompanied with high morbidity of up to 33% and 90 days mortality of up to 9% in the fragile elderly patients as is seen in the results of the Dutch Surgical Colorectal Audit (DSCA) of 2013. Additionally, rectal cancer surgery is associated with substantial loss of health related quality of life due to defecation disorders, incontinence, sexual dysfunction and stoma related morbidity. These disadvantages are acceptable when radical surgery is the only option for cure. Advances in technology enabled the development of local excision of early rectal cancer with precise endoluminal microsurgery or local endoscopic excision resulting in a significant decrease in short- and long term morbidity. However current evidence is of inadequate quality to conclude on the oncologic safety of local treatment for early rectal cancer. Imaging can predict outcome and tailors treatment in more advanced cancer but fails in early cancer. Pathological assessment of the excised tumor tissue provides the optimal information on tumor stage, tumor characteristics and tumor differentiation, thereby it enables to predict the risk of recurrence after local treatment alone. For early rectal cancers, with a low risk on recurrence based on favourable tumor characteristics local excision is seen as safe and these patients do not require an additional treatment. However, for patients with early rectal cancer with a higher risk on recurrence based on tumor characteristics there is no consensus on the additional treatment after local excision. According to the National guideline these patients receive a TME procedure. However, for this subgroup of patients local treatment followed by chemoradiotherapy might also be oncological safe. Current evidence is of inadequate quality to be conclusive. For this subgroup of patients with early rectal cancer with high risk tumorcharacteristics the TESAR trial is designed, in which patiens will be randomised after local endoluminal excision between an additional TME-procedure (standard) and adjuvant chemoradiotherapy. Primary endpoint of the study will be local recurrence at 3 three year follow-up.
- Conditions
- Rectal Cancer
- Being tested
- Adjuvant chemoradiotherapy, Additional TME surgery, capecitabine
- Keywords
- Local therapy, Adjuvant chemoradiotherapy, Rectal preserving
- Medical subject headings
- Rectal Neoplasms
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Adjuvant chemoradiotherapyRadiation
Patients will receive capecitabine 825 mg/m2 twice a day for 5 weeks only on weekdays. This will be combined with 1.8 Gy in 25 fractions with a limited dose only on the mesorectum
Additional TME surgeryProcedure or surgery
capecitabineDrug
| Study group | Role | What they receive |
|---|---|---|
| Total Mesorectal Excision | Active comparator | After local excision patients will receive additional TME surgery Receives: Procedure: Additional TME surgery |
| Adjuvant chemoradiotherapy | Experimental | After local excision. Patients will receive capecitabine 825 mg/m2 twice a day for 5 weeks only on weekdays. This will be combined with 1.8 Gy in 25 fractions with a limited dose only on the mesorectum Receives: Radiation: Adjuvant chemoradiotherapy; Drug: capecitabine |
What is being measured
The primary outcome is the main question the study is designed to answer.
Recurrence free at 3 year follow-up
Measured: 3 year
Secondary outcomes (1)
Treatment related morbidity
Measured: 1,3 and 5 year follow-up
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted25 Feb 2015 (estimated)
- Study startOct 2015
- Primary completionJun 2022 (estimated)
- Study completionJan 2023 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (2)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 Amsterdam UMC, location VUmcThe 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 3
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- None (open label)
- Enrolment
- 302 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Amsterdam UMC, location VUmc
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Jurriaan B. Tuynman, Amsterdam UMC, location VUmc
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02371304
- Sponsor's protocol ID
- NL50364.029
- Acronym
- TESAR
- Status last verified
- May 2020
- First submitted
- 18 Feb 2015
- Last updated
- 21 May 2020
- Results posted
- No
- Data monitoring committee
- Yes
Publications
Moolenaar 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 42202843Borstlap WA, Tanis PJ, Koedam TW, Marijnen CA, Cunningham C, Dekker E, van Leerdam ME, Meijer G, van Grieken N, Nagtegaal ID, Punt CJ, Dijkgraaf MG, De Wilt JH, Beets G, de Graaf EJ, van Geloven AA, Gerhards MF, van Westreenen HL, van de Ven AW, van Duijvendijk P, de Hingh IH, Leijtens JW, Sietses C, Spillenaar-Bilgen EJ, Vuylsteke RJ, Hoff C, Burger JW, van Grevenstein WM, Pronk A, Bosker RJ, Prins H, Smits AB, Bruin S, Zimmerman DD, Stassen LP, Dunker MS, Westerterp M, Coene PP, Stoot J, Bemelman WA, Tuynman JB. A multi-centred randomised trial of radical surgery versus adjuvant chemoradiotherapy after local excision for early rectal cancer. BMC Cancer. 2016 Jul 21;16:513. doi: 10.1186/s12885-016-2557-x.
PubMed 27439975
Study at a glance
From the registry record, last updated by the sponsor on 21 May 2020. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Rectal Preserving Treatment for Early Rectal Cancer. A Multi-centred Randomised Trial of Radical Surgery Versus Adjuvant Chemoradiotherapy After Local Excision for Early Rectal Cancers
- ClinicalTrials.gov ID
- NCT02371304
- Acronym / sponsor ID
- TESAR / NL50364.029
- Conditions
- Rectal Cancer
- Keywords
- Local therapy, Adjuvant chemoradiotherapy, Rectal preserving
- Phase
- Phase 3
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 302 participants (estimated)
- Lead sponsor
- Amsterdam UMC, location VUmcUniversity, hospital or other
- Study start
- Oct 2015
- Primary completion
- Jun 2022 (estimated)
- Study completion
- Jan 2023 (estimated)
- First posted
- 25 Feb 2015 (estimated)
- 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.
Current therapy for early colorectal cancer is radical Total Mesorectal Excision (TME). Colorectal surgical resections are accompanied with high morbidity of up to 33% and 90 days mortality of up to 9% in the fragile elderly patients as is seen in the results of the Dutch Surgical Colorectal Audit (DSCA) of 2013. Additionally, rectal cancer surgery is associated with substantial loss of health related quality of life due to defecation disorders, incontinence, sexual dysfunction and stoma related morbidity. These disadvantages are acceptable when radical surgery is the only option for cure. Advances in technology enabled the development of local excision of early rectal cancer with precise endoluminal microsurgery or local endoscopic excision resulting in a significant decrease in short- and long term morbidity. However current evidence is of inadequate quality to conclude on the oncologic safety of local treatment for early rectal cancer. Imaging can predict outcome and tailors treatment in more advanced cancer but fails in early cancer. Pathological assessment of the excised tumor tissue provides the optimal information on tumor stage, tumor characteristics and tumor differentiation, thereby it enables to predict the risk of recurrence after local treatment alone. For early rectal cancers, with a low risk on recurrence based on favourable tumor characteristics local excision is seen as safe and these patients do not require an additional treatment. However, for patients with early rectal cancer with a higher risk on recurrence based on tumor characteristics there is no consensus on the additional treatment after local excision. According to the National guideline these patients receive a TME procedure. However, for this subgroup of patients local treatment followed by chemoradiotherapy might also be oncological safe. Current evidence is of inadequate quality to be conclusive. For this subgroup of patients with early rectal cancer with high risk tumorcharacteristics the TESAR trial is designed, in which patiens will be randomised after local endoluminal excision between an additional TME-procedure (standard) and adjuvant chemoradiotherapy. Primary endpoint of the study will be local recurrence at 3 three year follow-up.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Total Mesorectal Excision | Active comparator | Procedure: Additional TME surgeryAfter local excision patients will receive additional TME surgery |
| Adjuvant chemoradiotherapy | Experimental | Radiation: Adjuvant chemoradiotherapy, Drug: capecitabineAfter local excision. Patients will receive capecitabine 825 mg/m2 twice a day for 5 weeks only on weekdays. This will be combined with 1.8 Gy in 25 fractions with a limited dose only on the mesorectum |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (19 listed)
- Patient has had an endoluminal local excision (by TEM, TAMIS, TSPM, EMR/ESD or polypectomy) of an early rectal cancer without carcinoma in the resection plane.
- Patients with carcinoma in the resection plane or in case of unreliable resection planes (EMR/ESD) no macroscopic residual tumour confirmed by endoscopy are eligible for randomisation.
- Only lesions for which TME surgery is indicated can be included (if a partial mesorectal excision (PME) is indicated the patient should be excluded).
- Pathological confirmation of the rectal adenocarcinoma fulfilling the following criteria: T1 with size 3-5 cm of carcinoma or pT1, maximum size of carcinoma of 3 cm, with at least poor differentiation, Haggit 4 and/or sm3, lymphatic and/or venous invasion.
- Pathological confirmation of the rectal adenocarcinoma fulfilling the following criteria: pT2, maximum size of carcinoma of 3 cm, well/moderate differentiated and without lymphatic or venous invasion.
Key exclusion criteria (16 listed)
- Incomplete or inconclusive resection margin with macroscopic residual tumour.
- T1 tumour with carcinoma < 3 cm, moderate/well differentiated, without sm3, venous or lymphatic invasion.
- T1 tumour with carcinoma of >5 cm and T2 tumour with carcinoma of > 3 cm.
- Presence of metastatic disease or recurrent rectal tumour.
- Previous pelvic radiation.
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 |
|---|---|---|
| Adjuvant chemoradiotherapyPatients will receive capecitabine 825 mg/m2 twice a day for 5 weeks only on weekdays. This will be combined with 1.8 Gy in 25 fractions with a limited dose only on the mesorectum | Radiation | Adjuvant chemoradiotherapy |
| Additional TME surgery | Procedure or surgery | Total Mesorectal Excision |
| capecitabine | Drug | Adjuvant chemoradiotherapy |
Primary outcome
Recurrence free at 3 year follow-up
Time frame: 3 year
1 secondary outcome
Treatment related morbidity
Time frame: 1,3 and 5 year follow-up
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 21 May 2020.
- Derived from this study: 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.
- Derived from this study: PubMed 27439975Borstlap WA, Tanis PJ, Koedam TW, Marijnen CA, Cunningham C, Dekker E, van Leerdam ME, Meijer G, van Grieken N, Nagtegaal ID, Punt CJ, Dijkgraaf MG, De Wilt JH, Beets G, de Graaf EJ, van Geloven AA, Gerhards MF, van Westreenen HL, van de Ven AW, van Duijvendijk P, de Hingh IH, Leijtens JW, Sietses C, Spillenaar-Bilgen EJ, Vuylsteke RJ, Hoff C, Burger JW, van Grevenstein WM, Pronk A, Bosker RJ, Prins H, Smits AB, Bruin S, Zimmerman DD, Stassen LP, Dunker MS, Westerterp M, Coene PP, Stoot J, Bemelman WA, Tuynman JB. A multi-centred randomised trial of radical surgery versus adjuvant chemoradiotherapy after local excision for early rectal cancer. BMC Cancer. 2016 Jul 21;16:513. doi: 10.1186/s12885-016-2557-x.
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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. This study is not recruiting at the moment.
Lisanne Smits contact
Jurriaan Tuynman contact
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 3 study testing Adjuvant chemoradiotherapy, Additional TME surgery and capecitabine in people with Rectal Cancer, run by Amsterdam UMC, location VUmc at 1 site in Netherlands.
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 19 inclusion and 16 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: status not confirmed, as of the sponsor's last update on 21 May 2020. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Netherlands. 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.
What does this phase mean?
Phase 3 studies compare the treatment with the current standard treatment or a placebo in a large group, to confirm how well it works and watch for side effects.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Lisanne Smits (l.j.smits@amsterdamumc.nl), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Recurrence free at 3 year follow-up (time frame: 3 year). 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 NCT02371304, which also lists 2 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 21 May 2020.