Ignite Creation Date:
2024-05-06 @ 8:26 PM
Last Modification Date:
2024-10-26 @ 3:28 PM
Study NCT ID:
NCT06386315
Status:
RECRUITING
Last Update Posted:
2024-05-24
First Post:
2024-04-23
Brief Title:
Reduced Dose Radiotherapy for the Treatment of Indolent Non-Hodgkin Lymphoma
Sponsor:
Mayo Clinic
Organization:
Mayo Clinic
Study Overview
Official Title:
Reduced Dose Hypofractionated Radiotherapy 3Gy X 3 Fractions for Indolent Non-Hodgkin Lymphoma POSEIDON a Multisite Phase 2 Randomized Trial
Status:
RECRUITING
Status Verified Date:
2024-10
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
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 andor 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 v50 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 PETcomputed 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 PETCT 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 PETCT 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
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 v50 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 PETcomputed 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 PETCT 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 PETCT 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
Study Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
False
Is a FDA Regulated Device?:
False
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
False
Is an FDA AA801 Violation?:
None
Secondary IDs
| Secondary ID | Type | Domain | Link |
|---|---|---|---|
| NCI-2024-03242 | REGISTRY | None | None |
| 23-010273 | OTHER | None | None |
| MC230808 | OTHER | Mayo Clinic | None |