Reduced Dose Hypofractionated Radiotherapy (3Gy X 3 Fractions) for Indolent Non-Hodgkin Lymphoma (POSEIDON): a Multisite Phase 2 Randomized Trial

Description

This phase II trial compares the safety, side effects and effectiveness of reduced dose radiation therapy to standard of care dose radiation in treating patients with indolent non-Hodgkin lymphoma. Radiation therapy uses high energy x-rays, particles, or radioactive seeds to kill cancer cells and shrink tumors. Standard of care radiation treatment for indolent non-Hodgkin lymphoma is usually delivered in 12 treatments. Studies have shown indolent lymphoma to be sensitive to radiation treatment, however, larger doses have higher rates of toxicities. A reduced radiation dose may be safe, tolerable and/or effective compared to standard of care radiation dose in treating patients with indolent non-Hodgkin lymphoma.PRIMARY OBJECTIVE: I. To show that 9 Gy in 3 fractions has significantly reduced acute toxicity (grade ≥ 2 adverse events at least possibly related to radiation treatment within 14 days after the end of radiation treatment (according to Common Terminology Criteria for Adverse Ev

Trial Eligibility

Inclusion Criteria: * Age ≥ 18 years * Histological confirmation of indolent B-cell lymphoma that can include any of the following: * Follicular lymphoma (grade 1 or 2 or 3A) * Marginal zone lymphoma (nodal or extranodal) * Any stage disease * Initial, refractory, or relapsed disease. If relapse involves the site to be treated there must be evidence of disease progression * Eastern Cooperative Oncology Group (ECOG) performance status (PS) ≤ 3 * Negative pregnancy test done ≤ 7 days prior to registration, for persons of childbearing potential only * Provide written informed consent * Ability to complete questionnaire(s) by themselves * Willing to return to enrolling institution for follow-up (during the active monitoring phase of the study). Virtual visits can also be considered as an option for applicable items * Confirmation from radiation oncologist of suitability to participate in study Exclusion Criteria: * Any of the following: * Pregnant women * Nursing women * Men or women of childbearing potential who are unwilling to employ adequate contraception * T-cell lymphoma * Small and chronic lymphocytic lymphoma * Grade 3B follicular lymphoma

Study Info

Interventions

Locations Recruiting

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