Rectal CancerPhase 4NG-STNCT07483060
Next Generation STAR-TREC (NG-ST) - Organ Preservation in Early Rectal Cancer
A Phase 4 study testing Capecitabine + Radiotherapy and Total Mesorectal Excision (TME) in people with Rectal Cancer, run by Vastra Gotaland Region.
Trial summary
This study evaluates whether mesorectal chemoradiotherapy with a limited radiation target volume can achieve a sustained clinical complete response in patients with early-stage rectal cancer, allowing surgery to be safely deferred. 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?
- Capecitabine + Radiotherapy and Total Mesorectal Excision (TME)
- Type of treatment
- Pill or oral medicine, Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 90 participants
- Where
- No sites listed yet
- Study dates
- 12 Mar 2026to Dec 2031
- Phase
- Phase 4
- 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
- Age ≥ 18 years
- Written informed consent
- Biopsy-proven rectal adenocarcinoma
- Tumor located <12 cm from the anal verge
- MRI-staged T1-T3b tumor
- N0 or NX (no radiologic evidence of nodal metastases)
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- M0 or MX (no radiological evidence of distant metastases)
- ECOG performance status 0-1
- Multidisciplinary team (MDT) assessment confirming that both total mesorectal excision (TME) and chemoradiotherapy are feasible treatment options
Who cannot join
- MRI-defined N1 or higher nodal disease
- Distant metastases (M1)
- MRI extramural vascular invasion (mriEMVI)
- Threatened mesorectal fascia (≤1 mm on MRI)
- Maximum tumor diameter > 40 mm
- MRI defined mucinous tumor
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- No residual luminal tumor following prior endoscopic resection
- Recurrent rectal cancer
- Prior pelvic radiotherapy
- Uncontrolled significant cardiorespiratory comorbidity
- Known complete dihydropyrimidine dehydrogenase (DPYD) deficiency
- Known Gilbert's syndrome
- Pregnancy or breastfeeding
- Concomitant medication contraindicated with capecitabine that cannot be safely discontinued
- Age <18 years
Trial locations and contacts
No sites are listed yet. Contact the study team or a site near you to ask about taking part.
Jennifer Park, MD, PhD contact
About this study
Official title: Next Generation STAR-TREC: A Prospective Multicenter Study Evaluating Organ Preservation With Mesorectal Chemoradiotherapy in Early Rectal Cancer
This study evaluates whether mesorectal chemoradiotherapy with a limited radiation target volume can achieve a sustained clinical complete response in patients with early-stage rectal cancer, allowing surgery to be safely deferred. Patients may choose between standard total mesorectal excision (TME) surgery or organ preservation with chemoradiotherapy followed by structured surveillance. The study aims to assess oncologic safety, organ preservation rates, and quality of life.
Read the detailed description
Background and Rationale
Standard treatment for early-stage rectal cancer is total mesorectal excision (TME), which provides good oncologic control but may result in substantial functional morbidity. Even in early tumors, radical surgery can lead to bowel dysfunction (including low anterior resection syndrome), urinary and sexual dysfunction, and in some cases permanent stoma formation. While oncologic outcomes are generally favorable, the long-term impact on quality of life remains significant for many patients.
Neoadjuvant chemoradiotherapy (CRT) has been shown to induce tumor regression in rectal cancer, and in a subset of patients a clinical complete response (cCR) may be achieved. In such cases, surgery may potentially be deferred under strict surveillance protocols, a strategy often referred to as organ preservation or "watch and wait." Previous prospective and international studies, including STAR-TREC, have demonstrated promising rates of clinical complete response in selected patients with early rectal tumors.
Study Objectives
Primary Objective To determine whether mesorectal chemoradiotherapy (50 Gy in 25 fractions combined with capecitabine 825 mg/m² twice daily on radiotherapy days) can achieve a sustained clinical complete response at one year in patients with early rectal cancer, allowing surgery to be safely deferred.
Secondary Objectives
- To evaluate local recurrence and local regrowth rates
- To assess distant metastases and overall survival
- To evaluate organ preservation rates at 3 years
- To assess surgical morbidity (if surgery is performed)
- To evaluate patient-reported outcomes including quality of life, bowel function, urinary function, and sexual function
- To perform health economic evaluation
Study Design
NG-ST is a national, multicenter, prospective, non-randomized phase IV cohort study conducted under EU Regulation 536/2014 (CTR). The study is classified as a low-intervention clinical trial, as capecitabine is an authorized medicinal product used within its marketing authorization, albeit at an earlier tumor stage than standard routine.
Eligible patients have biopsy-confirmed rectal adenocarcinoma ≤12 cm from the anal verge and MRI-staged T1-T3b, N0/NX, M0 disease. Both TME surgery and chemoradiotherapy must be considered feasible treatment options by the multidisciplinary team (MDT).
Patients are offered a choice between standard upfront TME surgery and organ preservation with mesorectal chemoradiotherapy.
Interventions
Organ Preservation Arm Radiotherapy: 50 Gy delivered in 25 fractions (2 Gy per fraction), 5 days per week over 5 weeks.
Capecitabine: 825 mg/m² orally twice daily on radiotherapy days.
Structured response assessment is performed 6-8 weeks after completion of CRT using MRI, endoscopy, and clinical examination. Patients achieving clinical complete response enter a structured surveillance program. Patients without complete response proceed to TME surgery.
Standard Surgery Arm Patients undergo total mesorectal excision (TME) according to local standards. Surgical approach is at the discretion of the treating surgeon.
Definition of Clinical Complete Response
- No residual tumor or suspicious lymph nodes on MRI
- No visible tumor on endoscopy (scar or fibrosis permitted)
- No palpable tumor on digital rectal examination
Follow-Up
Patients are followed prospectively with structured surveillance including MRI, endoscopy, clinical examination, and quality-of-life questionnaires. Follow-up continues for at least three years, with longer-term survival assessment up to five years.
Safety Monitoring
Adverse events (AE), serious adverse events (SAE), and suspected unexpected serious adverse reactions (SUSAR) are recorded and reported according to EU CTR requirements. Annual Safety Reports are submitted via CTIS in accordance with Article 43 of Regulation (EU) 536/2014.
Significance
The NG-ST study aims to prospectively evaluate an organ-preserving strategy that may reduce the need for radical surgery and improve long-term functional outcomes without compromising oncologic safety in selected patients with early rectal cancer.
- Conditions
- Rectal Cancer
- Being tested
- Capecitabine + Radiotherapy, Total Mesorectal Excision (TME)
- Keywords
- Early rectal cancer, organ preservation, watch and wait, chemoradiotherapy, clinical complete response, quality of life, low anterior resection syndrom
- Medical subject headings
- Rectal Neoplasms
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Capecitabine + RadiotherapyCombination product
Capecitabine is administered orally at a dose of 825 mg/m² twice daily on radiotherapy treatment days (5 days per week) during the 5-week course of mesorectal radiotherapy. External beam radiotherapy is delivered to the primary tumor and surrounding mesorectum at a total dose of 50 Gy in 25 fractions (2 Gy per fraction), administered once daily, 5 days per week, over approximately 5 weeks, according to protocol-defined target volumes.
Total Mesorectal Excision (TME)Procedure or surgery
Total mesorectal excision (TME) is performed according to standard surgical practice for rectal cancer. The surgical approach (open, laparoscopic, or robotic) is determined by the treating surgeon in accordance with local guidelines.
| Study group | Role | What they receive |
|---|---|---|
| Mesorectal chemoradiotherapy | Experimental | Participants receive mesorectal chemoradiotherapy consisting of radiotherapy (50 Gy in 25 fractions over 5 weeks) combined with capecitabine 825 mg/m² orally twice daily on radiotherapy days. Treatment response is assessed 6-8 weeks after completion using high-resolution MRI, endoscopy, and clinical examination. Participants achieving clinical complete response enter a structured "watch and wait" surveillance program with regular MRI, endoscopy, and clinical follow-up. If incomplete response or tumor regrowth is detected at any time during surveillance, total mesorectal excision (TME) surgery is recommended according to standard of care. Receives: Combination Product: Capecitabine + Radiotherapy |
| Standard Surgery (Total Mesorectal Excision) | Active comparator | Participants undergo upfront total mesorectal excision (TME) according to standard surgical practice and national guidelines for early rectal cancer. The surgical approach (open, laparoscopic, or robotic) is at the discretion of the treating surgeon. No neoadjuvant radiotherapy is administered. Postoperative care and oncologic follow-up are conducted according to national guidelines. Participants contribute clinical, oncologic, and patient-reported outcome data for comparison with the organ preservation arm. Receives: Procedure: Total Mesorectal Excision (TME) |
What is being measured
The primary outcome is the main question the study is designed to answer.
Sustained clinical complete response at 1 year
Proportion of participants in the organ preservation arm who achieve a clinical complete response (cCR) and remain without surgical resection at 1 year after initiation of treatment. Clinical complete response is defined by absence of residual tumor on MRI, no visible tumor on endoscopy (scar/fibrosis permitted), and no palpable tumor on clinical examination.
Measured: 1 year
Secondary outcomes (10)
Clinical Complete Response at 3 Years
Proportion of participants achieving and maintaining clinical complete response without surgical resection at 3 years.
Measured: 3 years
Local Recurrence Rate
Proportion of participants developing local recurrence after initial treatment.
Measured: 3 years
Distant metastases
Proportion of participants developing distant metastatic disease.
Measured: 3 years
Overall Survival
Overall survival measured from study inclusion to death from any cause.
Measured: up to 5 years
Organ Preservation Rate
Proportion of participants with preserved rectum without permanent stoma at 3 years.
Measured: 3 years
Surgical Morbidity
Postoperative complications measured using the Comprehensive Complication Index (CCI) in participants undergoing surgery.
Measured: Within 90 days after surgery
Total Length of Hospital Stay
Total number of days hospitalized, including readmissions, within the first year after diagnosis.
Measured: Within 1 year after diagnosis
Patient reported quality of life
Quality of life will be measured using the European Organisation for Research and Treatment of Cancer (EORTC) quality of life questionnaire (QLQ) C30. Scores range from 0-100, with higher scores representing better functioning and global health status but worse symptoms on symptom scales.
Measured: up to 3 years
Patient reported quality of life
Quality of life related to colorectal cancer will be assessed using the European Organisation for Research and Treatment of Cancer colorectal cancer module (EORTC QLQ-CR29). Scores are linearly transformed to a 0-100 scale; higher scores on functional scales indicate better functioning, whereas higher scores on symptom scales indicate greater symptom burden.
Measured: up to 3 years
Bowel function
Low Anterior Resection Syndrome will be assessed using the Low Anterior Resection Syndrome (LARS) Score, a validated patient-reported outcome measure evaluating bowel dysfunction after rectal cancer surgery. Scores range from 0 to 42, with higher scores indicating more severe bowel dysfunction (0-20 = no LARS, 21-29 = minor LARS, 30-42 = major LARS).
Measured: Up to 3 years
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted19 Mar 2026
- Study start12 Mar 2026 (estimated)
- Primary completion31 Dec 2028 (estimated)
- Study completionDec 2031 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Rectal CancerStudies of the same condition, open and under way.
- More trials run by Vastra Gotaland RegionThe 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 4
- Primary purpose
- Treatment
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- Model description
- This is a non-randomized, patient preference-based parallel assignment study. Eligible patients with early rectal cancer are offered a choice between standard upfront total mesorectal excision (TME) surgery and organ preservation with mesorectal chemoradiotherapy. Participants remain in their selected treatment group and are followed prospectively according to the study protocol.
- Masking
- None (open label)
- Enrolment
- 90 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Vastra Gotaland Region
- Sponsor type
- Other government
- Collaborators
- Skane University Hospital, Stockholm South General Hospital
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07483060
- Sponsor's protocol ID
- 2025-522955-25-00
- Other IDs
- 2025
- Acronym
- NG-ST
- Status last verified
- Mar 2026
- First submitted
- 4 Mar 2026
- Last updated
- 19 Mar 2026
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 19 Mar 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Next Generation STAR-TREC: A Prospective Multicenter Study Evaluating Organ Preservation With Mesorectal Chemoradiotherapy in Early Rectal Cancer
- ClinicalTrials.gov ID
- NCT07483060
- Acronym / sponsor ID
- NG-ST / 2025-522955-25-00
- Conditions
- Rectal Cancer
- Keywords
- Early rectal cancer, organ preservation, watch and wait, chemoradiotherapy, clinical complete response, quality of life, low anterior resection syndrom
- Phase
- Phase 4
- Study type
- Interventional
- Recruitment status
- Not yet recruiting
- Enrolment
- 90 participants (estimated)
- Lead sponsor
- Vastra Gotaland RegionOther government
- Collaborators
- Skane University Hospital, Stockholm South General Hospital
- Study start
- 12 Mar 2026 (estimated)
- Primary completion
- 31 Dec 2028 (estimated)
- Study completion
- Dec 2031 (estimated)
- First posted
- 19 Mar 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.
This study evaluates whether mesorectal chemoradiotherapy with a limited radiation target volume can achieve a sustained clinical complete response in patients with early-stage rectal cancer, allowing surgery to be safely deferred. Patients may choose between standard total mesorectal excision (TME) surgery or organ preservation with chemoradiotherapy followed by structured surveillance. The study aims to assess oncologic safety, organ preservation rates, and quality of life.
Detailed description
Background and Rationale
Standard treatment for early-stage rectal cancer is total mesorectal excision (TME), which provides good oncologic control but may result in substantial functional morbidity. Even in early tumors, radical surgery can lead to bowel dysfunction (including low anterior resection syndrome), urinary and sexual dysfunction, and in some cases permanent stoma formation. While oncologic outcomes are generally favorable, the long-term impact on quality of life remains significant for many patients.
Neoadjuvant chemoradiotherapy (CRT) has been shown to induce tumor regression in rectal cancer, and in a subset of patients a clinical complete response (cCR) may be achieved. In such cases, surgery may potentially be deferred under strict surveillance protocols, a strategy often referred to as organ preservation or "watch and wait." Previous prospective and international studies, including STAR-TREC, have demonstrated promising rates of clinical complete response in selected patients with early rectal tumors.
Study Objectives
Primary Objective To determine whether mesorectal chemoradiotherapy (50 Gy in 25 fractions combined with capecitabine 825 mg/m² twice daily on radiotherapy days) can achieve a sustained clinical complete response at one year in patients with early rectal cancer, allowing surgery to be safely deferred.
Secondary Objectives
- To evaluate local recurrence and local regrowth rates
- To assess distant metastases and overall survival
- To evaluate organ preservation rates at 3 years
- To assess surgical morbidity (if surgery is performed)
- To evaluate patient-reported outcomes including quality of life, bowel function, urinary function, and sexual function
- To perform health economic evaluation
Study Design
NG-ST is a national, multicenter, prospective, non-randomized phase IV cohort study conducted under EU Regulation 536/2014 (CTR). The study is classified as a low-intervention clinical trial, as capecitabine is an authorized medicinal product used within its marketing authorization, albeit at an earlier tumor stage than standard routine.
Eligible patients have biopsy-confirmed rectal adenocarcinoma ≤12 cm from the anal verge and MRI-staged T1-T3b, N0/NX, M0 disease. Both TME surgery and chemoradiotherapy must be considered feasible treatment options by the multidisciplinary team (MDT).
Patients are offered a choice between standard upfront TME surgery and organ preservation with mesorectal chemoradiotherapy.
Interventions
Organ Preservation Arm Radiotherapy: 50 Gy delivered in 25 fractions (2 Gy per fraction), 5 days per week over 5 weeks.
Capecitabine: 825 mg/m² orally twice daily on radiotherapy days.
Structured response assessment is performed 6-8 weeks after completion of CRT using MRI, endoscopy, and clinical examination. Patients achieving clinical complete response enter a structured surveillance program. Patients without complete response proceed to TME surgery.
Standard Surgery Arm Patients undergo total mesorectal excision (TME) according to local standards. Surgical approach is at the discretion of the treating surgeon.
Definition of Clinical Complete Response
- No residual tumor or suspicious lymph nodes on MRI
- No visible tumor on endoscopy (scar or fibrosis permitted)
- No palpable tumor on digital rectal examination
Follow-Up
Patients are followed prospectively with structured surveillance including MRI, endoscopy, clinical examination, and quality-of-life questionnaires. Follow-up continues for at least three years, with longer-term survival assessment up to five years.
Safety Monitoring
Adverse events (AE), serious adverse events (SAE), and suspected unexpected serious adverse reactions (SUSAR) are recorded and reported according to EU CTR requirements. Annual Safety Reports are submitted via CTIS in accordance with Article 43 of Regulation (EU) 536/2014.
Significance
The NG-ST study aims to prospectively evaluate an organ-preserving strategy that may reduce the need for radical surgery and improve long-term functional outcomes without compromising oncologic safety in selected patients with early rectal cancer.
Study design
- Primary purpose
- Treatment
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
- Model description
- This is a non-randomized, patient preference-based parallel assignment study. Eligible patients with early rectal cancer are offered a choice between standard upfront total mesorectal excision (TME) surgery and organ preservation with mesorectal chemoradiotherapy. Participants remain in their selected treatment group and are followed prospectively according to the study protocol.
| Arm | Type | Receives |
|---|---|---|
| Mesorectal chemoradiotherapy | Experimental | Combination Product: Capecitabine + RadiotherapyParticipants receive mesorectal chemoradiotherapy consisting of radiotherapy (50 Gy in 25 fractions over 5 weeks) combined with capecitabine 825 mg/m² orally twice daily on radiotherapy days. Treatment response is assessed 6-8 weeks after completion using high-resolution MRI, endoscopy, and clinical examination. Participants achieving clinical complete response enter a structured "watch and wait" surveillance program with regular MRI, endoscopy, and clinical follow-up. If incomplete response or tumor regrowth is detected at any time during surveillance, total mesorectal excision (TME) surgery is recommended according to standard of care. |
| Standard Surgery (Total Mesorectal Excision) | Active comparator | Procedure: Total Mesorectal Excision (TME)Participants undergo upfront total mesorectal excision (TME) according to standard surgical practice and national guidelines for early rectal cancer. The surgical approach (open, laparoscopic, or robotic) is at the discretion of the treating surgeon. No neoadjuvant radiotherapy is administered. Postoperative care and oncologic follow-up are conducted according to national guidelines. Participants contribute clinical, oncologic, and patient-reported outcome data for comparison with the organ preservation arm. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (9 listed)
- Age ≥ 18 years
- Written informed consent
- Biopsy-proven rectal adenocarcinoma
- Tumor located <12 cm from the anal verge
- MRI-staged T1-T3b tumor
Key exclusion criteria (15 listed)
- MRI-defined N1 or higher nodal disease
- Distant metastases (M1)
- MRI extramural vascular invasion (mriEMVI)
- Threatened mesorectal fascia (≤1 mm on MRI)
- Maximum tumor diameter > 40 mm
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 |
|---|---|---|
| Capecitabine + RadiotherapyCapecitabine is administered orally at a dose of 825 mg/m² twice daily on radiotherapy treatment days (5 days per week) during the 5-week course of mesorectal radiotherapy. External beam radiotherapy is delivered to the primary tumor and surrounding mesorectum at a total dose of 50 Gy in 25 fractions (2 Gy per fraction), administered once daily, 5 days per week, over approximately 5 weeks, according to protocol-defined target volumes. | Combination product | Mesorectal chemoradiotherapy |
| Total Mesorectal Excision (TME)Total mesorectal excision (TME) is performed according to standard surgical practice for rectal cancer. The surgical approach (open, laparoscopic, or robotic) is determined by the treating surgeon in accordance with local guidelines. | Procedure or surgery | Standard Surgery (Total Mesorectal Excision) |
Primary outcome
Sustained clinical complete response at 1 year
Time frame: 1 year
Proportion of participants in the organ preservation arm who achieve a clinical complete response (cCR) and remain without surgical resection at 1 year after initiation of treatment. Clinical complete response is defined by absence of residual tumor on MRI, no visible tumor on endoscopy (scar/fibrosis permitted), and no palpable tumor on clinical examination.
10 secondary outcomes
Clinical Complete Response at 3 Years
Time frame: 3 years
Local Recurrence Rate
Time frame: 3 years
Distant metastases
Time frame: 3 years
Overall Survival
Time frame: up to 5 years
Organ Preservation Rate
Time frame: 3 years
Surgical Morbidity
Time frame: Within 90 days after surgery
Total Length of Hospital Stay
Time frame: Within 1 year after diagnosis
Patient reported quality of life
Time frame: up to 3 years
Patient reported quality of life
Time frame: up to 3 years
Bowel function
Time frame: Up to 3 years
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 19 Mar 2026.
- Individual participant dataSharing planned: No
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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.
Jennifer Park, MD, PhD contact
Questions about this trial
What is this clinical trial studying?
A Phase 4 study testing Capecitabine + Radiotherapy and Total Mesorectal Excision (TME) in people with Rectal Cancer, run by Vastra Gotaland Region.
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 9 inclusion and 15 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: opening soon, as of the sponsor's last update on 19 Mar 2026. Status can change between updates, so confirm with the study contact before making plans.
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 4 studies take place after a treatment is approved, to learn more about its long-term benefits and risks in everyday use.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
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 Eva Angenete, MD, PhD (+46-31-342-10-00, eva.angenete@gu.se), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Sustained clinical complete response at 1 year (time frame: 1 year). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
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 19 Mar 2026.