Trial Title:
Reduced Dose Radiotherapy for the Treatment of Indolent Non-Hodgkin Lymphoma
NCT ID:
NCT06386315
Condition:
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: Official terms:
Lymphoma
Lymphoma, Non-Hodgkin
Lymphoma, B-Cell
Recurrence
Study type:
Interventional
Study phase:
Phase 2
Overall status:
Recruiting
Study design:
Allocation:
Randomized
Intervention model:
Parallel Assignment
Primary purpose:
Treatment
Masking:
None (Open Label)
Intervention:
Intervention type:
Procedure
Intervention name:
Computed Tomography
Description:
Undergo CT or PET/CT
Arm group label:
ARM 1 (reduced dose ISRT)
Arm group label:
ARM 2 (SOC ISRT)
Other name:
CAT
Other name:
CAT Scan
Other name:
Computed Axial Tomography
Other name:
Computerized Axial Tomography
Other name:
Computerized axial tomography (procedure)
Other name:
Computerized Tomography
Other name:
Computerized Tomography (CT) scan
Other name:
CT
Other name:
CT Scan
Other name:
tomography
Intervention type:
Procedure
Intervention name:
Endoscopic Procedure
Description:
Undergo endoscopy
Arm group label:
ARM 1 (reduced dose ISRT)
Arm group label:
ARM 2 (SOC ISRT)
Other name:
Endoscopic Examination
Other name:
Endoscopy
Other name:
ES
Intervention type:
Radiation
Intervention name:
Involved-site Radiation Therapy (3 Fractions)
Description:
Undergo ISRT in 3 fractions
Arm group label:
ARM 1 (reduced dose ISRT)
Other name:
ISRT
Intervention type:
Radiation
Intervention name:
Involved-site Radiation Therapy (12 Fractions)
Description:
Undergo ISRT in 12 fractions
Arm group label:
ARM 2 (SOC ISRT)
Other name:
ISRT
Intervention type:
Procedure
Intervention name:
Positron Emission Tomography
Description:
Undergo PET/CT
Arm group label:
ARM 1 (reduced dose ISRT)
Arm group label:
ARM 2 (SOC ISRT)
Other name:
Medical Imaging, Positron Emission Tomography
Other name:
PET
Other name:
PET Scan
Other name:
Positron emission tomography (procedure)
Other name:
Positron Emission Tomography Scan
Other name:
Positron-Emission Tomography
Other name:
proton magnetic resonance spectroscopic imaging
Other name:
PT
Intervention type:
Other
Intervention name:
Questionnaire Administration
Description:
Ancillary studies
Arm group label:
ARM 1 (reduced dose ISRT)
Arm group label:
ARM 2 (SOC ISRT)
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 9 Gy in 3 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 1: Patients undergo reduced dose ISRT once daily (QD) over 3 treatment fractions.
Patients also undergo CT or PET/CT throughout the study. Patients may additionally
undergo endoscopy during screening and during follow up.
ARM 2: 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, 3 months
then every 6 months for up to 2 years.
Criteria for eligibility:
Criteria:
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)
- 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
- Willing to return to enrolling institution for follow-up (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
- Men or women of childbearing potential who are unwilling to employ adequate
contraception
- T-cell lymphoma
- Small and chronic lymphocytic lymphoma
- Grade 3B follicular lymphoma
Gender:
All
Minimum age:
18 Years
Maximum age:
N/A
Healthy volunteers:
No
Locations:
Facility:
Name:
Mayo Clinic in Arizona
Address:
City:
Scottsdale
Zip:
85259
Country:
United States
Status:
Not yet recruiting
Contact:
Last name:
Clinical Trials Referral Office
Phone:
855-776-0015
Email:
mayocliniccancerstudies@mayo.edu
Contact backup:
Last name:
William G. Rule, MD
Facility:
Name:
Mayo Clinic in Florida
Address:
City:
Jacksonville
Zip:
32224-9980
Country:
United States
Status:
Recruiting
Contact:
Last name:
Clinical Trials Referral Office
Phone:
855-776-0015
Email:
mayocliniccancerstudies@mayo.edu
Contact backup:
Last name:
Bradford S. Hoppe, MD, MPH
Facility:
Name:
Mayo Clinic in Rochester
Address:
City:
Rochester
Zip:
55905
Country:
United States
Status:
Recruiting
Contact:
Last name:
Clinical Trials Referral Office
Phone:
855-776-0015
Email:
mayocliniccancerstudies@mayo.edu
Contact backup:
Last name:
Scott C. Lester, MD
Start date:
May 15, 2024
Completion date:
May 30, 2026
Lead sponsor:
Agency:
Mayo Clinic
Agency class:
Other
Source:
Mayo Clinic
Record processing date:
ClinicalTrials.gov processed this data on November 12, 2024
Source: ClinicalTrials.gov page:
https://clinicaltrials.gov/ct2/show/NCT06386315
https://www.mayo.edu/research/clinical-trials
