Reduced Dose Radiotherapy for the Treatment of Indolent Non-Hodgkin Lymphoma
NCT ID: NCT06386315
Last Updated: 2025-11-12
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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RECRUITING
PHASE2
112 participants
INTERVENTIONAL
2024-05-15
2026-05-30
Brief Summary
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Detailed Description
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I. To show that the experimental arm (9 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
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Study Design
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RANDOMIZED
PARALLEL
TREATMENT
NONE
Study Groups
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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.
Computed Tomography
Undergo CT or PET/CT
Endoscopic Procedure
Undergo endoscopy
Involved-site Radiation Therapy (3 Fractions)
Undergo ISRT in 3 fractions
Positron Emission Tomography
Undergo PET/CT
Questionnaire Administration
Ancillary studies
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.
Computed Tomography
Undergo CT or PET/CT
Endoscopic Procedure
Undergo endoscopy
Involved-site Radiation Therapy (12 Fractions)
Undergo ISRT in 12 fractions
Positron Emission Tomography
Undergo PET/CT
Questionnaire Administration
Ancillary studies
Interventions
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Computed Tomography
Undergo CT or PET/CT
Endoscopic Procedure
Undergo endoscopy
Involved-site Radiation Therapy (3 Fractions)
Undergo ISRT in 3 fractions
Involved-site Radiation Therapy (12 Fractions)
Undergo ISRT in 12 fractions
Positron Emission Tomography
Undergo PET/CT
Questionnaire Administration
Ancillary studies
Other Intervention Names
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Eligibility Criteria
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Inclusion Criteria
* 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
* 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
18 Years
ALL
No
Sponsors
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Mayo Clinic
OTHER
Responsible Party
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Principal Investigators
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Bradford S. Hoppe, MD, MPH
Role: PRINCIPAL_INVESTIGATOR
Mayo Clinic
Locations
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Mayo Clinic in Arizona
Scottsdale, Arizona, United States
Mayo Clinic in Florida
Jacksonville, Florida, United States
Mayo Clinic Health System in Albert Lea
Albert Lea, Minnesota, United States
Mayo Clinic Health System - Mankato
Mankato, Minnesota, United States
Mayo Clinic in Rochester
Rochester, Minnesota, United States
Mayo Clinic Health System-Eau Claire Clinic
Eau Claire, Wisconsin, United States
Mayo Clinic Health System-Franciscan Healthcare
La Crosse, Wisconsin, United States
Countries
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Central Contacts
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Facility Contacts
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Clinical Trials Referral Office
Role: primary
Clinical Trials Referral Office
Role: primary
Clinical Trials Referral Office
Role: primary
Clinical Trials Referral Office
Role: primary
Clinical Trials Referral Office
Role: primary
Clinical Trials Referral Office
Role: primary
Clinical Trials Referral Office
Role: primary
Related Links
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Mayo Clinic Clinical Trials
Other Identifiers
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NCI-2024-03242
Identifier Type: REGISTRY
Identifier Source: secondary_id
23-010273
Identifier Type: OTHER
Identifier Source: secondary_id
MC230808
Identifier Type: OTHER
Identifier Source: secondary_id
MC230808
Identifier Type: -
Identifier Source: org_study_id