Treatment of Adenocarcinoma of the Rectum With Transanal Local Excision for Complete Responders

Description

The current standard of care for rectal cancer has diminished local recurrence and enhanced survival. Quality of life, however, remains poor for many patients and the probability of distant recurrence is high. In this study, we will attempt to reduce the distant recurrence rate and improve quality of life by making changes in the timing and administration of chemotherapy and radiation and doing less invasive rectal surgery when indicated.

Conditions

Rectal Cancer

Study Overview

Study Details

Study overview

The current standard of care for rectal cancer has diminished local recurrence and enhanced survival. Quality of life, however, remains poor for many patients and the probability of distant recurrence is high. In this study, we will attempt to reduce the distant recurrence rate and improve quality of life by making changes in the timing and administration of chemotherapy and radiation and doing less invasive rectal surgery when indicated.

Treatment of T2-T3/NO-N+ Adenocarcinoma of the Rectum by Neoadjuvant Chemotherapy (FOLFOX) Followed by Preoperative Chemo (5FU/Capecitabine)-Radio Therapy (CRT) With Transanal Local Excision for Complete Responders

Treatment of Adenocarcinoma of the Rectum With Transanal Local Excision for Complete Responders

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 or mid rectum (up to 11 cm from the anal verge)
  • 4. Clinical stage T3/N0-N1M0. Patients with low T2 who will need abdominal perineal resection are also eligible.
  • 1. Clinical staging will be estimated based on the combination of the following assessments:
  • 1. Physical examination by the primary surgeon
  • 2. Computed Tomography or Positron Emission Tomography/Computed Tomography scan of chest, abdomen and pelvis
  • 3. Pelvic MRI and endoscopic ultrasound
  • * Less than 18 years of age
  • * Do not complete informed consent
  • * Pregnant women

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 SME

Study Record Dates

2025-01-01