Watchful Waiting for Complete Responders to Therapy in Rectal Cancer

Description

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

Rectal Cancer

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Study Overview

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Study Details

Study overview

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.

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

Watchful Waiting for Complete Responders to Therapy in Rectal Cancer

Condition
Rectal Cancer
Intervention / Treatment

-

Contacts and Locations

Detroit

Ascension St. John Hospital, Detroit, Michigan, United States, 48236

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

For general information about clinical research, read Learn About Studies.

Eligibility Criteria

  • 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.
  • 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

Ages Eligible for Study

18 Years to 95 Years

Sexes Eligible for Study

ALL

Accepts Healthy Volunteers

No

Collaborators and Investigators

Ascension South East Michigan,

Amr Aref, MD, PRINCIPAL_INVESTIGATOR, Ascension St. John Hospital

Study Record Dates

2029-07-09