OncoMatch/Clinical Trials/NCT07669298
Active Surveillance vs Adjuvant Chemoradiotherapy for Locally Resected Intermediate-Risk T1 Rectal Cancer
Official title: Active Surveillance vs Adjuvant Chemoradiotherapy for Locally Resected Intermediate-Risk T1 Rectal Cancer: Multicentre Randomised Controlled Trial
Is NCT07669298 recruiting? Yes, currently enrolling (Oct 2026). This NA trial studies non-drug interventions for rectal cancer.
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. 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. 2. 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: 1. 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. 2. 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.
Check if I qualifyExtracted eligibility criteria
Cancer type
Colorectal Cancer
Biomarker criteria
Excluded: MLH1 loss
Mismatch repair deficiency (dMMR) or microsatellite instability-high (MSI-H)
Excluded: MSH2 loss
Mismatch repair deficiency (dMMR) or microsatellite instability-high (MSI-H)
Excluded: MSH6 loss
Mismatch repair deficiency (dMMR) or microsatellite instability-high (MSI-H)
Excluded: PMS2 loss
Mismatch repair deficiency (dMMR) or microsatellite instability-high (MSI-H)
Excluded: MSI high
Mismatch repair deficiency (dMMR) or microsatellite instability-high (MSI-H)
Disease stage
Grade: poor histological differentiation (grade 3), high tumour budding (grade 2-3)
Performance status
ECOG 0–2(Ambulatory, capable of self-care)
Prior therapy
Cannot have received: pelvic radiation
Prior receipt of pelvic radiation
Lab requirements
Blood counts
ANC ≥ 1.5 × 10^9/L; Hb ≥ 8.0 g/dL (transfusions allowed); Platelet count ≥ 75 × 10^9/L
Kidney function
Serum creatinine clearance ≥ 50 mL/min (Cockcroft-Gault); Absence of significant proteinuria (<1 g/24 h if screening positive)
Liver function
Serum albumin ≥ 3.0 g/dL; Total bilirubin ≤ 2.0 mg/dL; AST ≤ 3 × ULN; ALT ≤ 3× ULN; ALP ≤ 3 × ULN
Adequate hematologic, liver, and renal function as per protocol laboratory criteria
Structured fields extracted by AI. May contain errors — verify against the official protocol.
Frequently asked questions
Is NCT07669298 currently recruiting?
Yes, this trial is currently recruiting patients.
Are there prior therapy exclusions?
Yes. Prior pelvic radiation disqualifies patients from enrollment.
Are patients with MLH1 alterations eligible?
No. MLH1 loss is an exclusion criterion.
Are patients with MSH2 alterations eligible?
No. MSH2 loss is an exclusion criterion.
Could you qualify for this trial?
Enter your biomarker results to see how this trial's eligibility criteria match your specific cancer profile.
Check if I qualifyRelated pages