RECRUITING

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

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 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.

Official Title

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

Quick Facts

Study Start:2016-02-26
Study Completion:2025-01-01
Study Type:Not specified
Phase:Not Applicable
Enrollment:Not specified
Status:RECRUITING

Study ID

NCT03941366

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

Contacts and Locations

Study Contact

Lisa C Miller, BA
CONTACT
313-343-3166
lisa.miller4@ascension.org
Susan M Szpunar, PhD
CONTACT
313-343-7838
susan.szpunar@ascension.org

Principal Investigator

Amr Aref, MD
PRINCIPAL_INVESTIGATOR
Ascension SME

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 SME

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 Date2016-02-26
Study Completion Date2025-01-01

Study Record Updates

Study Start Date2016-02-26
Study Completion Date2025-01-01

Terms related to this study

Additional Relevant MeSH Terms

  • Rectal Cancer