Trials / Recruiting

RecruitingNCT06386315

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

Status: Recruiting
Phase: Phase 2
Study type: Interventional
Enrollment: 112 (estimated)

Sponsor: Mayo Clinic · Academic / Other
Sex: All
Age: 18 Years
Healthy volunteers: Not accepted

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.

Detailed 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 survival. EXPLORATORY OBJECTIVES: I. Financial toxicity will be assessed at the end of radiation treatment. II. Financial health care expenditure will be assessed at the end of radiation treatment III. Late toxicity. CORRELATIVE RESEARCH OBJECTIVES: I. Biopsies of enrolled patients will be evaluated for pathological assessment of cellular and genetic mutations to correlate them with disease local relapse and radiation resistance. II. Patients will have their baseline positron emission tomography (PET)/computed tomography (CT) scan undergo auto-segmentation to calculate the functional imaging 18-fluoro-deoxyglucose (FDG) metabolic tumor volume (MTV), total lesions glycolysis (TLG) and maximum standardized uptake volume (SUVmax) of the sites to be treated with involved-site radiation therapy (ISRT) using MIMvista platform to correlate it with disease local relapse and treatment response. OUTLINE: Patients are randomized to 1 of 2 arms. ARM I: Patients undergo reduced dose ISRT once daily (QD) over 3, 2, or 5 treatment fractions. Patients also undergo CT or PET/CT throughout the study. Patients may additionally undergo endoscopy during screening and during follow up. ARM II: Patients undergo standard of care (SOC) radiation therapy QD over 12 treatment fractions. Patients also undergo CT or PET/CT throughout the study. Patients may additionally undergo endoscopy during screening and during follow up. After completion of study treatment, patients are followed up at days 7 and 14, months 3 and 6, and then every 6 months for up to 2 years post-radiation therapy.

Conditions

Interventions

Type	Name	Description
PROCEDURE	Computed Tomography	Undergo CT or PET/CT
PROCEDURE	Endoscopic Procedure	Undergo endoscopy
RADIATION	Involved-site Radiation Therapy (3 Fractions)	Undergo ISRT in 3 fractions
RADIATION	Involved-site Radiation Therapy (12 Fractions)	Undergo ISRT in 12 fractions
PROCEDURE	Positron Emission Tomography	Undergo PET/CT
OTHER	Questionnaire Administration	Ancillary studies

Timeline

Start date: 2024-05-15
Primary completion: 2026-05-30
Completion: 2026-05-30
First posted: 2024-04-26
Last updated: 2025-11-24

Locations

7 sites across 1 country: United States

Source: ClinicalTrials.gov record NCT06386315. Inclusion in this directory is not an endorsement.