Study on 3-Year Disease-Free Survival in Patients with Locally Advanced Rectal Cancer Treated with Chemoradiation and Surgery or Non-Surgical Management

Sponsor: Memorial Sloan Kettering Cancer Center

Sponsor score: 60

ClinicalTrials ID:NCT02008656

This clinical trial is investigating whether patients with locally advanced rectal cancer have better outcomes when treated with a combination of chemoradiation and either surgery or non-surgical management, compared to traditional treatments.

Patient Parameters

Program Overview

The purpose of this study is to determine if patients with locally advanced rectal cancer have improved disease-free survival over three years when treated with a combination of chemoradiation and either surgery or non-surgical management. This approach is compared to the standard treatment of chemoradiation followed by surgery and additional chemotherapy.

Eligibility Criteria

Inclusion Criteria

  • Diagnosed with adenocarcinoma of the rectum.
  • Cancer is at Stage II or III based on MRI results.
  • Tumor requires complete surgical removal.
  • No signs of cancer spread to other parts of the body.
  • No previous radiation therapy to the pelvic area.
  • No prior chemotherapy or surgery for rectal cancer.
  • Age 18 or older (19 in some Canadian provinces).
  • No active infections needing systemic antibiotics (oral antibiotics may be allowed).
  • Good overall health with an ECOG performance status of 0 to 2.
  • Women of childbearing potential must test negative for pregnancy and agree to use effective birth control.
  • Must be able to read, agree to, and sign an informed consent form.
  • Meet specific blood test criteria for white blood cells, hemoglobin, platelets, and liver function.

Exclusion Criteria

  • Recurrent rectal cancer.
  • Tumors that cannot be surgically removed.
  • High creatinine levels indicating kidney issues.
  • Previous pelvic radiation therapy.
  • Inability to undergo an MRI.
  • Recent history of arterial blood clots or heart-related events.
  • History of blood clots more than six months ago may be eligible if on stable anticoagulant therapy.
  • Cannot receive other cancer treatments or experimental therapies during the study.
  • Women who are pregnant, breastfeeding, or not using effective birth control.
  • Other medical or psychiatric conditions that may interfere with the study.
  • History of another cancer within the past five years, except for certain skin or cervical cancers.

Locations

FACILITYZIPCITYSTATE
University of California, Irvine92697IrvineCalifornia
St. Joseph Hospital92868-3849OrangeCalifornia
University of California San Francisco94143San FranciscoCalifornia
John Muir Health94598Walnut CreekCalifornia
University of Colorado80045AuroraColorado
Washington Hospital Center20010Washington D.C.District of Columbia
University Of South Florida33620TampaFlorida
Cleveland Clinic Florida33331WestonFlorida
University of Chicago60637ChicagoIllinois
University of Michigan48168NorthvilleMichigan

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