RecruitingEarly Phase 1NCT03594630

Active Surveillance and Chemotherapy Before Surgery in Treating Participants With Stage II-III Rectal Cancer

Organ Preservation With Active Surveillance After Chemoradiation in Rectal Cancer (OPTION)

Sponsor

M.D. Anderson Cancer Center

Enrollment

120 participants

Start Date

Mar 13, 2024

Study Type

INTERVENTIONAL

Conditions

Rectal Adenocarcinoma Stage II Rectal Cancer AJCC v8 Stage III Rectal Cancer AJCC v8 Stage IIA Rectal Cancer AJCC v8 Stage IIB Rectal Cancer AJCC v8 Stage IIC Rectal Cancer AJCC v8 Stage IIIA Rectal Cancer AJCC v8 Stage IIIB Rectal Cancer AJCC v8 Stage IIIC Rectal Cancer AJCC v8

Summary

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.

Eligibility

Min Age: 18 Years

Plain Language Summary

Simplified for easier understanding

This trial is testing a treatment approach for stage II and III rectal cancer where patients receive chemotherapy before surgery, with close monitoring to see if some patients might not need the full surgery if they respond very well to treatment. **You may be eligible if...** - You have been diagnosed with rectal cancer (specifically adenocarcinoma), confirmed by a biopsy - Your tumor is located in the lower part of the rectum (within 12 cm of the anal opening) - Your cancer is stage II or III - You are physically well enough to tolerate treatment (ECOG performance status 0, 1, or 2) - You are eligible for surgery to remove the cancer **You may NOT be eligible if...** - Your cancer has spread beyond the areas treatable by radiation - You have serious other medical conditions that prevent surgery or chemotherapy - You have had previous pelvic radiation - You are pregnant Talk to your doctor to see if this trial is right for you.

This summary was AI-generated to explain the trial in plain language. It is not medical advice. Always discuss eligibility with your doctor before enrolling in a clinical trial.

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Interventions

DRUGChemotherapy

Receive chemotherapy

OTHERPatient Observation

Receive active surveillance

OTHERQuestionnaire Administration

Ancillary studies

PROCEDUREResection of Rectum

Undergo surgical resection

Locations(1)

M D Anderson Cancer Center

Houston, Texas, United States

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NCT03594630

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