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

Status: Recruiting
Location: See all (7) locations...
Intervention Type: Procedure, Other, Radiation
Study Type: Interventional
Study Phase: Phase 2
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
Participation Requirements
Sex: All
Minimum Age: 18
Healthy Volunteers: f
View:

• 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

Locations
United States
Arizona
Mayo Clinic in Arizona
RECRUITING
Scottsdale
Florida
Mayo Clinic in Florida
RECRUITING
Jacksonville
Minnesota
Mayo Clinic Health System in Albert Lea
RECRUITING
Albert Lea
Mayo Clinic Health System - Mankato
RECRUITING
Mankato
Mayo Clinic in Rochester
RECRUITING
Rochester
Wisconsin
Mayo Clinic Health System-Eau Claire Clinic
RECRUITING
Eau Claire
Mayo Clinic Health System-Franciscan Healthcare
RECRUITING
La Crosse
Contact Information
Primary
Clinical Trials Referral Office
mayocliniccancerstudies@mayo.edu
855-776-0015
Time Frame
Start Date: 2024-05-15
Estimated Completion Date: 2026-05-30
Participants
Target number of participants: 112
Treatments
Experimental: ARM 1 (reduced dose ISRT)
Patients undergo reduced dose ISRT once daily (excluding weekends): 9 Gy delivered in 3 treatment fractions or 8 Gy in 2 fractions. At physician discretion, patients may receive 10 Gy in 5 fractions. Patients also undergo CT or PET/CT throughout the study. Patients may additionally undergo endoscopy during screening and during follow up.
Active_comparator: ARM 2 (SOC ISRT)
Patients undergo standard of care (SOC) radiation therapy once daily (excluding weekends): 24 Gy in 12 treatment fractions. Patients also undergo CT or PET/CT throughout the study. Patients may additionally undergo endoscopy during screening and during follow up.
Related Therapeutic Areas
Sponsors
Leads: Mayo Clinic

This content was sourced from clinicaltrials.gov

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