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Clinical Trial NCT07483060 (NG-ST) for Rectal Cancer is not yet recruiting. See the Trial Radar Card View and AI discovery tools for all the details. Or ask anything here. | ||
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Next Generation STAR-TREC (NG-ST) - Organ Preservation in Early Rectal Cancer Phase 4 90
Clinical Trial NCT07483060 (NG-ST) is designed to study Treatment for Rectal Cancer. This Phase 4 interventional study is not yet recruiting. Enrollment is planned to begin on 12 March 2026 until the study accrues 90 participants. Led by Vastra Gotaland Region, this study is expected to complete by 1 December 2031. The latest data from ClinicalTrials.gov was last updated on 19 March 2026.
Brief 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. Patients may choose between standard total mesorectal excision (TME) surgery or organ preservation with chemoradiotherapy followed by structured surveillance. The study aims to assess onco...Show More
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 ...
Show MoreOfficial Title
Next Generation STAR-TREC: A Prospective Multicenter Study Evaluating Organ Preservation With Mesorectal Chemoradiotherapy in Early Rectal Cancer
Conditions
Rectal CancerOther Study IDs
- NG-ST
- 2025-522955-25-00
NCT ID Number
Start Date (Actual)
2026-03-12
Last Update Posted
2026-03-19
Completion Date (Estimated)
2031-12
Enrollment (Estimated)
90
Study Type
Interventional
PHASE
Phase 4
Status
Not yet recruiting
Keywords
Early rectal cancer
organ preservation
watch and wait
chemoradiotherapy
clinical complete response
quality of life
low anterior resection syndrom
organ preservation
watch and wait
chemoradiotherapy
clinical complete response
quality of life
low anterior resection syndrom
Primary Purpose
Treatment
Design Allocation
Non-Randomized
Interventional Model
Parallel
Masking
None (Open Label)
Arms / Interventions
| Participant Group/Arm | Intervention/Treatment |
|---|---|
ExperimentalMesorectal chemoradiotherapy 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...Show More | Capecitabine + Radiotherapy 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-defin...Show More |
Active ComparatorStandard Surgery (Total Mesorectal Excision) 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,...Show More | 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. |
Primary Outcome Measures
Secondary Outcome Measures
| Outcome Measure | Measure Description | Time Frame |
|---|---|---|
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. | 1 year |
| Outcome Measure | Measure Description | Time Frame |
|---|---|---|
Clinical Complete Response at 3 Years | Proportion of participants achieving and maintaining clinical complete response without surgical resection at 3 years. | 3 years |
Local Recurrence Rate | Proportion of participants developing local recurrence after initial treatment. | 3 years |
Distant metastases | Proportion of participants developing distant metastatic disease. | 3 years |
Overall Survival | Overall survival measured from study inclusion to death from any cause. | up to 5 years |
Organ Preservation Rate | Proportion of participants with preserved rectum without permanent stoma at 3 years. | 3 years |
Surgical Morbidity | Postoperative complications measured using the Comprehensive Complication Index (CCI) in participants undergoing surgery. | Within 90 days after surgery |
Total Length of Hospital Stay | Total number of days hospitalized, including readmissions, within the first year after diagnosis. | 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. | 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. | 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). | Up to 3 years |
Participation Assistant
Eligibility Criteria
Eligible Ages
Adult, Older Adult
Minimum Age
18 Years
Eligible Sexes
All
- 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)
- 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
- 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
- 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
Vastra Gotaland Region- Skane University Hospital
- Stockholm South General Hospital
Study Central Contact
Contact: Eva Angenete, MD, PhD, +46-31-342-10-00, [email protected]
Contact: Jennifer Park, MD, PhD, [email protected]
No location data.