Study on Reduced Dose Radiation Therapy for Treating Slow-Growing Non-Hodgkin Lymphoma

Sponsor: Mayo Clinic

Sponsor score: 60
Inactive

ClinicalTrials ID:NCT06386315

Provider View

This clinical trial is testing if a lower dose of radiation therapy is as safe and effective as the standard dose for treating patients with slow-growing non-Hodgkin lymphoma. The study aims to find out if the reduced dose can minimize side effects while still effectively treating the cancer.

Patient Parameters

Program Overview

This study is comparing the safety and effectiveness of a lower dose of radiation therapy to the standard dose in patients with slow-growing non-Hodgkin lymphoma. Radiation therapy uses high-energy rays to kill cancer cells and shrink tumors. The standard treatment usually involves 12 sessions, but this study is testing if fewer sessions with a lower dose can be just as effective and cause fewer side effects.

Description

The main goal of this study is to see if a lower dose of radiation (9 Gy in 3 sessions) causes fewer side effects compared to the standard dose (24 Gy in 12 sessions). Researchers will also look at how the treatment affects patients' quality of life, how well the cancer responds, and how long patients stay cancer-free.

The study will also explore the financial impact of the treatment and any long-term side effects. Researchers will examine tissue samples to understand how the cancer might resist treatment and use imaging scans to measure the cancer's response.

Participants will be randomly assigned to one of two groups:

  • Group 1: Receives the lower dose of radiation over 3 sessions. Participants will have CT or PET/CT scans during the study and may have endoscopies during screening and follow-up.
  • Group 2: Receives the standard dose of radiation over 12 sessions. Participants will also have CT or PET/CT scans and may have endoscopies during screening and follow-up.

After finishing the treatment, participants will have follow-up visits at 7 and 14 days, 3 months, and then every 6 months for up to 2 years.

Eligibility Criteria

Inclusion Criteria

  • Must be 18 years or older.
  • Have a confirmed diagnosis of slow-growing B-cell lymphoma, such as:
    • Follicular lymphoma (grade 1, 2, or 3A)
    • Marginal zone lymphoma (nodal or extranodal)
  • Can be at any stage of the disease.
  • Have initial, resistant, or returning disease, with evidence of progression if the site to be treated is involved.
  • Have a performance status score of 3 or less, meaning able to carry out some daily activities.
  • Negative pregnancy test for those who can become pregnant, done within 7 days before joining the study.
  • Able to provide written consent and complete questionnaires.
  • Willing to return for follow-up visits, which can be virtual if applicable.
  • Confirmed by a radiation oncologist as suitable for the study.

Exclusion Criteria

  • Pregnant or nursing women.
  • Men or women who can have children but are not willing to use contraception.
  • Have T-cell lymphoma.
  • Have small or chronic lymphocytic lymphoma.
  • Have grade 3B follicular lymphoma.

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