RECRUITING

Watchful Waiting for Complete Responders to Therapy in Rectal Cancer

Conditions

Study Overview

This clinical trial focuses on testing the efficacy of different digital interventions to promote re-engagement in cancer-related long-term follow-up care for adolescent and young adult (AYA) survivors of childhood 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.

Official Title

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

Quick Facts

Study Start:2018-07-10
Study Completion:2029-07-09
Study Type:Not specified
Phase:Not Applicable
Enrollment:Not specified
Status:RECRUITING

Study ID

NCT05526079

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.

Ages Eligible for Study:18 Years to 95 Years
Sexes Eligible for Study:ALL
Accepts Healthy Volunteers:No
Standard Ages:ADULT, OLDER_ADULT
Inclusion CriteriaExclusion Criteria
  1. 1. Age ≥ 18 years
  2. 2. Diagnosis of rectal invasive adenocarcinoma
  3. 3. Tumor in the low rectum lying \< 4 cm from the anal verge
  4. 4. Clinical stage T3/N0-N1M0.
  5. 5. Patients with low T2 who will need abdominal perineal resection are also eligible.
  1. 1. Age less than 18 years
  2. 2. Other forms of cancer
  3. 3. Tumors \>= 4 cm from the anal verge
  4. 4. Tumors of other clinical stages than listed above

Contacts and Locations

Study Contact

Amr Aref, MD
CONTACT
(313) 647-3100
amr.aref@ascension.org

Principal Investigator

Amr Aref, MD
PRINCIPAL_INVESTIGATOR
Ascension St. John Hospital

Study Locations (Sites)

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

Collaborators and Investigators

Sponsor: Ascension South East Michigan

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

Study Record Dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Registration Dates

Study Start Date2018-07-10
Study Completion Date2029-07-09

Study Record Updates

Study Start Date2018-07-10
Study Completion Date2029-07-09

Terms related to this study

Additional Relevant MeSH Terms

  • Rectal Cancer