Watchful Waiting for Complete Responders to Therapy in Rectal Cancer

Stopped early · Not applicable

Conditions studied: Rectal Cancer

In brief

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.

Key facts

Study ID

NCT05526079

Run by

Henry Ford Health System

People needed

15

Starts

2018-07-10

Expected to finish

2026-03-31

Last updated by the study team

2026-07-23

Who can join

Age: 18 and older, up to 95. Sex: any. Healthy volunteers: not accepted.

You may qualify if…

• Age ≥ 18 years
• Diagnosis of rectal invasive adenocarcinoma
• Tumor in the low rectum lying < 4 cm from the anal verge
• Clinical stage T3/N0-N1M0.
• Patients with low T2 who will need abdominal perineal resection are also eligible.

You may not qualify if…

• Age less than 18 years
• Other forms of cancer
• Tumors >= 4 cm from the anal verge
• Tumors of other clinical stages than listed above

Where it is running

• Ascension St. John Hospital — Detroit, Michigan, United States

Full record on ClinicalTrials.gov

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