Reduced Dose Radiotherapy for the Treatment of Indolent Non-Hodgkin Lymphoma
Reduced Dose Hypofractionated Radiotherapy (3Gy x 3 Fractions) for Indolent Non-Hodgkin Lymphoma (POSEIDON): A Multisite Phase 2 Randomized Trial
Mayo Clinic
112 participants
May 15, 2024
INTERVENTIONAL
Conditions
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.
Eligibility
Inclusion Criteria13
- 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 written informed consent
- Ability to complete questionnaire(s) by themselves or with assistance
- Willing to return to enrolling institution for follow-up visits (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 Criteria7
- Any of the following:
- Pregnant women
- Nursing women
- Women of childbearing potential who are unwilling to employ adequate contraception
- T-cell lymphoma
- Receiving treatment for small and chronic lymphocytic lymphoma
- Grade 3B follicular lymphoma
Interventions
Undergo CT or PET/CT
Undergo endoscopy
Undergo ISRT in 3 fractions
Undergo ISRT in 12 fractions
Undergo PET/CT
Ancillary studies
Locations(7)
View Full Details on ClinicalTrials.gov
For the most up-to-date information, visit the official listing.
NCT06386315