Study on Chemotherapy and Radiation-Free Treatment with Active Monitoring for Locally Advanced Rectal Cancer

Sponsor: University of Rochester

Sponsor score: 0

ClinicalTrials ID:NCT03781323

Provider View

This clinical trial is exploring a treatment approach for patients with locally advanced rectal cancer that uses chemotherapy without radiation or surgery, followed by active monitoring to see if the cancer responds completely.

Patient Parameters

Program Overview

The aim of this study is to see if patients with locally advanced rectal cancer can achieve a complete response to chemotherapy alone, without needing radiation or surgery. Patients will receive 10 cycles of chemotherapy (FOLFOX), with an evaluation after six cycles to check the cancer's response. If the cancer is stable or has progressed, further treatment will be decided by the doctor. If there is a partial or complete response, patients will continue with the full treatment and be closely monitored for any return of the cancer without immediate surgery. The study will measure how many patients achieve a complete response, as well as their survival without disease, overall survival, quality of life, and the safety of the treatment.

Description

Patients in this study will receive 10 cycles of chemotherapy using a combination of drugs called FOLFOX (fluorouracil, leucovorin, oxaliplatin). After six cycles, doctors will check how the cancer is responding. If the cancer is stable or has grown, the doctor will decide on the next steps. If the cancer has shrunk or disappeared, patients will finish the full treatment and be monitored closely to see if the cancer comes back, without having surgery right away. The main goal is to see how many patients have a complete or nearly complete response to the treatment. The study will also look at how long patients live without the cancer returning, their overall survival, their quality of life, and any side effects from the treatment.

Eligibility Criteria

Inclusion Criteria

  • Must be over 18 years old.
  • Have a confirmed diagnosis of rectal adenocarcinoma from a biopsy, located within 15 cm from the anal verge.
  • Cancer staging must be T3N0 or T1-3 with N1-2a disease.
  • Patients with lower rectal cancer not suitable for sphincter-sparing surgery can participate.
  • No evidence of cancer spread before starting the study.
  • Tumors must likely require total mesorectal excision (TME).
  • Must not have had any previous treatment for rectal cancer, including chemotherapy, radiation, or surgery.
  • No history of pelvic radiation.
  • No previous use of platinum-based drugs.
  • No active infections needing IV antibiotics.
  • No other active cancers.
  • No cancer treatment in the past 3 years.
  • Blood tests must meet specific criteria:
    • Neutrophil count >1500/mm3
    • Platelet count >100,000/mm3
    • Hemoglobin >8.0 g/dL
    • Total bilirubin and creatinine <1.5x upper limit of normal
    • AST and ALT <3x upper limit of normal
  • Women who can become pregnant must test negative for pregnancy and agree to use effective birth control during the study.
  • Must understand the study and sign informed consent. Non-English speakers can participate with appropriate consent procedures.

Exclusion Criteria

  • Recurrent or treatment-resistant rectal cancer.
  • Cancer staging of T1N0, T2N0, T4a, T4b, or N2b.
  • Any signs of cancer spread.
  • Cancer that cannot be surgically removed.
  • Tumors close to surgical margins or mesorectal fascia.
  • Inability to undergo MRI scans.
  • Recent history of arterial blood clots, such as heart attack or stroke.
  • History of blood clots more than 6 months ago may be eligible if on stable anticoagulant therapy.
  • Serious heart, liver, or kidney diseases that prevent chemotherapy use.
  • Severe nerve damage.
  • Participation in other experimental therapy trials.
  • Pregnant or breastfeeding women.
  • Men and women planning to have children.
  • Other medical or psychiatric conditions deemed unsuitable for the study.
  • History of other invasive cancers in the past 3 years, except for certain non-threatening cancers.

Locations

FACILITYZIPCITYSTATE
University of Rochester, James P. Wilmot Cancer Center14642RochesterNew York
University of Rochester14642RochesterNew York

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