Actively Recruiting
Organ Preservation With Active Surveillance After Chemoradiation in Rectal Cancer (OPTION)
Led by M.D. Anderson Cancer Center · Updated on 2026-05-20
120
Participants Needed
1
Research Sites
N/A
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
Researchers are evaluating how well active surveillance combined with chemotherapy before surgery works for treating people with stage II-III rectal cancer. This study aims to understand if delaying surgery after these treatments can better preserve organs and manage tumor growth. The trial also explores patient decision-making, communication with providers, and safety outcomes after treatment. Participants are assigned to one of two groups based on their response to treatment. Group I includes those who have a complete clinical response and undergo standard surgical removal of the rectum. Group II includes those with a complete response who receive active surveillance and additional chemotherapy for up to four months, with surgery reserved for tumor regrowth or incomplete response. Follow-up schedules differ between groups, with more frequent visits for Group II to monitor for disease progression. During the study, participants will undergo various assessments including physical exams, imaging scans like MRI, and quality of life questionnaires. Researchers will collect tissue samples to study treatment effects and biomarkers. Key outcomes measured include organ preservation rates, tumor regrowth, time to surgery or death, and long-term survival. Safety is monitored through recording adverse events, and participants are followed for up to five years to assess ongoing health and treatment impact.
CONDITIONS
Brief 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 (ECOG) performance status of 0, 1, or 2
- Clinical Stage II or III based on exams and imaging
- No known contraindication to standard fluoropyrimidine-based pelvic chemoradiation
- Patients of child-bearing potential must agree to use adequate contraception during and after treatment
- Willing to provide written informed consent
- Willing to return to the study site for all assessments
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 cancer undergoing active treatment that prevents standard chemoradiation or chemotherapy
- Unwilling or unable to undergo pelvic MRI
AI-Screening
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Your Study Journey
Duration - 2 to 4 weeks
Participants are screened for eligibility to participate in the trial.
1 visit (in-person)
Duration - Up to 4 months
Participants receive chemotherapy and/or undergo surgical resection depending on their group assignment. Group I participants undergo surgical resection after achieving clinical complete response. Group II participants receive active surveillance and consolidated chemotherapy for up to 4 months unless disease progression or unacceptable toxicity occurs. Participants with incomplete response or tumor regrowth may undergo surgical resection.
Visits occur during chemotherapy and active surveillance period; frequency depends on treatment and monitoring needs
Duration - Up to 3 years
After completing study treatment, participants are followed to monitor organ preservation, tumor regrowth, survival, and quality of life. Group I participants have follow-up visits at 6 and 12 months, then annually for up to 3 years. Group II participants have follow-up visits every 3 months for 18 months, every 6 months for 2 years, then annually for up to 3 years.
Follow-up visits occur every 3 months initially, then every 6 months, and finally annually depending on group and time since treatment
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
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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