MC230808 Reduced Dose Hypofractionated Radiotherapy (3Gy x 3 Fractions) for Indolent Non-Hodgkin Lymphoma (POSEIDON): A Multisite Phase 2 Randomized Trial
Mayo Clinic
Summary
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.
Description
PRIMARY OBJECTIVE: I. To show that the experimental arm \[9 gray (Gy) in 3 fractions, 8 Gy in 2 fractions, or 10 Gy in 5 fractions\] 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 \[according to Common Terminology Criteria for Adverse Events (CTCAE) version (v)5.0\] compared to 24 Gy in 12 fractions. SECONDARY OBJECTIVES: I. To evaluate patient reported quality of life. II. To evaluate response rate. III. To evaluate local control rate. IV. To evaluate relapse-free surviv…
Eligibility
- Age range
- 18+ years
- Sex
- All
- Healthy volunteers
- No
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) * Follicle center lymphoma * 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 wr…
Interventions
- ProcedureComputed Tomography
Undergo CT or PET/CT
- ProcedureEndoscopic Procedure
Undergo endoscopy
- RadiationInvolved-site Radiation Therapy (3 Fractions)
Undergo ISRT in 3 fractions
- RadiationInvolved-site Radiation Therapy (12 Fractions)
Undergo ISRT in 12 fractions
- ProcedurePositron Emission Tomography
Undergo PET/CT
- OtherQuestionnaire Administration
Ancillary studies
Locations (7)
- Mayo Clinic in ArizonaScottsdale, Arizona
- Mayo Clinic in FloridaJacksonville, Florida
- Mayo Clinic Health System in Albert LeaAlbert Lea, Minnesota
- Mayo Clinic Health System - MankatoMankato, Minnesota
- Mayo Clinic in RochesterRochester, Minnesota
- Mayo Clinic Health System-Eau Claire ClinicEau Claire, Wisconsin