Actively Recruiting

Phase 2
Age: 18Years - 95Years
All Genders
NCT05526079

Watchful Waiting for Complete Responders to Therapy in Rectal Cancer

Led by Henry Ford Health System · Updated on 2024-01-29

30

Participants Needed

1

Research Sites

573 weeks

Total Duration

On this page

AI-Summary

What this Trial Is About

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.

CONDITIONS

Official Title

Watchful Waiting for Complete Responders to Therapy in Rectal Cancer

Who Can Participate

Age: 18Years - 95Years
All Genders

Eligibility Criteria

Eligible

You may qualify if you...

  1. Age ≥ 18 years
  2. Diagnosis of rectal invasive adenocarcinoma
  3. Tumor in the low rectum lying < 4 cm from the anal verge
  4. Clinical stage T3/N0-N1M0.
  5. Patients with low T2 who will need abdominal perineal resection are also eligible.
Not Eligible

You will not qualify if you...

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

AI-Screening

AI-Powered Screening

Complete this quick 3-step screening to check your eligibility

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Trial Site Locations

Total: 1 location

1

Ascension St. John Hospital

Detroit, Michigan, United States, 48236

Actively Recruiting

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Research Team

A

Amr Aref, MD

CONTACT

How is the study designed?

Study Type

INTERVENTIONAL

Masking

NONE

Allocation

NA

Model

SINGLE_GROUP

Primary Purpose

TREATMENT

Number of Arms

1

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