About this trial
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 criteria
This trial does not accept healthy volunteersQualifiers
Age ≥ 18 years
Follicular lymphoma (grade 1 or 2 or 3A)
Marginal zone lymphoma (nodal or extranodal)
Follicle center lymphoma
Disqualifiers
Pregnant women
Nursing women
Women of childbearing potential who are unwilling to employ adequate contraception
T-cell lymphoma
Trial design
Parallel
Treatments tested in this trial
Computed Tomography
Procedure/SurgeryUndergo CT or PET/CT
Endoscopic Procedure
Procedure/SurgeryUndergo endoscopy
Involved-site Radiation Therapy (3 Fractions)
RadiationUndergo ISRT in 3 fractions
Involved-site Radiation Therapy (12 Fractions)
RadiationUndergo ISRT in 12 fractions
Positron Emission Tomography
Procedure/SurgeryUndergo PET/CT
Questionnaire Administration
Other interventionAncillary studies
Treatment groups
Trial outcomes
Primary outcomes
Incidence of grade 2 or higher acute adverse events (AEs)
AEs will be graded using Common Terminology Criteria for Adverse Events (CTCAE) version 5.0. Acute toxicity will be reported as a proportion calculated as the number of patients with acute toxicity divided by the total number of treatment patients. Treatment cycles are 5 days ±2 days (Arm 1) and 16 days ±2 days (Arm 2).
Secondary outcomes
Response rate
Response rate will be defined as the proportion of patients displaying response (complete response or partial response) at 3 months post treatment. Complete response is defined as the disappearance of all signs of cancer in response to treatment. Partial response is defined decrease in the size of target lesions by ≥ 50%, with no increase in the size of any lesion and no appearance of new lesions. Treated patients who do not have a 3-month evaluation will be classified as a non-response. Treatment cycles are 5 days ±2 days (Arm 1) and 16 days ±2 days (Arm 2).
Time to progression rate
Local control will be defined as the number of days from end of radiation treatment until first local recurrence within 24 months post radiation treatment. Treatment cycles are 5 days ±2 days (Arm 1) and 16 days ±2 days (Arm 2).
Patient reported quality of life
Patient reported quality of life will be measured using Functional Assessment of Chronic Illness Therapy-Fatigue (FACIT-F) scale, a 13-item questionnaire answered on a scale of 1-5 where 1=Not at all and 5=Very much. Treatment cycles are 5 days ±2 days (Arm 1) and 16 days ±2 days (Arm 2).
Sponsors and contacts
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