Indolent B-Cell Non-Hodgkin Lymphoma, Recurrent Indolent B-Cell Non-Hodgkin Lymphoma, Refractory Indolent B-Cell Non-Hodgkin Lymphoma, Recurrent Indolent Non-Hodgkin Lymphoma, Refractory Indolent Non-Hodgkin Lymphoma
Conditions
Brief 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.
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
Sponsors
Mayo Clinic
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
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 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 criteria
* 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
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Incidence of grade 2 or higher acute adverse events (AEs) | Up to 14 days after radiation treatment | 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
| Measure | Time frame | Description |
|---|---|---|
| Response rate | Up to 3 months after radiation treatment | 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 | Up to 24 months after radiation treatment | 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 | Up to 3 months after radiation treatment | 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). |
Countries
United States
Contacts
Primary ContactClinical Trials Referral Office
Outcome results
None listed