Study on Hypofractionated Radiation Therapy for Merkel Cell Carcinoma

Sponsor: M.D. Anderson Cancer Center

Sponsor score: 0
Inactive

ClinicalTrials ID:NCT05100095

Provider View

This clinical trial is exploring whether a new type of radiation therapy, called hypofractionated radiation, can effectively treat Merkel cell carcinoma by delivering higher doses over fewer days, potentially making it more convenient and less suppressive to the immune system.

Patient Parameters

Program Overview

This phase II study is testing a new approach to radiation therapy for patients with Merkel cell carcinoma, a type of skin cancer. The treatment, known as hypofractionated radiation therapy, uses higher doses of radiation over a shorter period compared to traditional methods. This could be more convenient for patients and may better support the immune system's response to the cancer.

Description

The main goals of this study are to:

  • Estimate how well hypofractionated radiation therapy controls the cancer in the original tumor area and nearby lymph nodes over two years.
  • Evaluate the time it takes for the cancer to return in different areas, the time until it spreads to distant parts of the body, and overall survival rates for patients receiving this treatment.
  • Assess any immediate or long-term side effects related to the radiation therapy.

Eligibility Criteria

Inclusion Criteria

  • Must have a confirmed diagnosis of Merkel cell carcinoma (MCC).
  • No signs of cancer spreading to distant parts of the body.
  • If receiving radiation to the primary tumor, surgery must have been done within 4 months before starting radiation.
  • If receiving radiation to lymph nodes, must have had a positive lymph node biopsy or lymph node surgery within 4 months before starting radiation.
  • Immunotherapy is allowed at any time during the study.
  • Must be 18 years or older.
  • Must be in relatively good health, with an ECOG performance status of 3 or less.
  • Can have other cancers if they do not interfere with this study.
  • Women and men must agree to use effective birth control during the study and for a period after, due to the risks of radiation.
  • Must be able to understand and sign a consent form to participate.

Exclusion Criteria

  • Cannot have had previous radiation to the area planned for treatment in this study.
  • Cannot have cancer that has spread to distant parts of the body.
  • Pregnant women cannot participate due to the risks of radiation.
  • Must be 18 years or older, as this treatment is not typically used in younger patients.

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