RecruitingPhase 2NCT05526079

Watchful Waiting for Complete Responders to Therapy in Rectal Cancer

Treatment of T2-T3/NO-N+ Adenocarcinoma of the Rectum by Neoadjuvant Chemotherapy (FOLFOX) Followed by Preoperative Chemo (Fluorouracil / Capecitabine)-Radio Therapy (CRT) With Watchful Waiting for Complete Responders

Sponsor

Henry Ford Health System

Enrollment

30 participants

Start Date

Jul 10, 2018

Study Type

INTERVENTIONAL

Conditions

Rectal Cancer

Summary

The purpose of this project is to determine if in a selected group of patients, at higher risk of wound dehiscence and other complications, treatment by local excision and management by a "watchful waiting" or an initial "non-operative management" approach, with an offer of radical resection only to those patients whose tumors demonstrate "regrowth" will maintain acceptable local control and overall survival rate for the whole cohort.

Eligibility

Min Age: 18 YearsMax Age: 95 Years

Plain Language Summary

Simplified for easier understanding

This study is looking at whether people with rectal cancer who have a complete response to treatment (meaning the tumor appears to have disappeared) can be safely monitored with regular check-ups instead of undergoing surgery. **You may be eligible if...** - You are 18 or older - You have been diagnosed with rectal adenocarcinoma (a common type of rectal cancer) - Your tumor is in the very lowest part of the rectum (less than 4 cm from the anal opening) - Your cancer is at a specific stage (T3/N0-N1M0, or a low T2 tumor requiring extensive surgery) **You may NOT be eligible if...** - You are under 18 - You have a different type of cancer (not rectal adenocarcinoma) - Your tumor is 4 cm or more from the anal opening - Your cancer is at a different stage than those listed above 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

OTHERWatchfuf waiting

Careful review of patient response with the hope of avoiding radical surgery.

Locations(1)

Ascension St. John Hospital

Detroit, Michigan, United States

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NCT05526079

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