Actively Recruiting
Active Surveillance and Chemotherapy Before Surgery in Treating Participants With Stage II-III Rectal Cancer
Led by M.D. Anderson Cancer Center · Updated on 2025-11-06
120
Participants Needed
1
Research Sites
137 weeks
Total Duration
On this page
Sponsors
M
M.D. Anderson Cancer Center
Lead Sponsor
N
National Cancer Institute (NCI)
Collaborating Sponsor
AI-Summary
What this Trial Is About
This pilot trial studies how well active surveillance and chemotherapy before surgery work in treating participants with stage II-III rectal cancer. Active surveillance involves monitoring participants for additional tumor growth after receiving cancer treatment. Drugs used in chemotherapy work in different ways to stop the growth of tumor cells, either by killing the cells, by stopping them from dividing, or by stopping them from spreading. It is not yet known whether deferring surgery after active surveillance and chemotherapy will work better in treating participants with stage II-III rectal cancer.
CONDITIONS
Official Title
Active Surveillance and Chemotherapy Before Surgery in Treating Participants With Stage II-III Rectal Cancer
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Histologically confirmed diagnosis of rectal adenocarcinoma
- Eligible for curative resection of rectal adenocarcinoma
- Rectal tumor located 12 cm or less from the anal verge by endoscopy or MRI
- Nodal involvement confined to the radiation field
- Radiologically measurable or clinically evaluable disease
- Eastern Cooperative Oncology Group performance status of 0, 1, or 2
- Clinical Stage II or III rectal cancer with N2 disease defined as four or more lymph nodes at least 10 mm
- Clinical staging based on physical exam, CT or PET/CT scans, and pelvic MRI as specified
- No known contraindication to standard fluoropyrimidine-based pelvic chemoradiation
- If of child-bearing potential, willing to use adequate contraception during and after treatment
- Willing to provide written informed consent
- Willing to return for all study assessments at the enrolling medical site
You will not qualify if you...
- Diagnosis of inflammatory bowel disease (IBD)
- Diagnosis of MSI-H colorectal cancer at time of consent
- Recurrent rectal cancer
- Tumor causing symptomatic bowel obstruction (patients with diverting ostomy are eligible)
- Any prior pelvic radiation
- Other invasive malignancy undergoing active treatment that precludes standard chemoradiation or chemotherapy
- Unwilling or unable to undergo pelvic MRI
AI-Screening
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Trial Site Locations
Total: 1 location
1
M D Anderson Cancer Center
Houston, Texas, United States, 77030
Actively Recruiting
Research Team
G
George J. Chang
CONTACT
How is the study designed?
Study Type
INTERVENTIONAL
Masking
NONE
Allocation
NON_RANDOMIZED
Model
PARALLEL
Primary Purpose
TREATMENT
Number of Arms
2
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