Back to resultsLow-dose Radiotherapy in iNHL
Primary Purpose
Indolent Lymphoma, Low-dose Radiotherapy
Status
Recruiting
Phase
Phase 2
Locations
China
Study Type
Interventional
Intervention
Low-dose radiotherapy
Sponsored by
About this trial
This is an interventional treatment trial for Indolent Lymphoma focused on measuring indolent lymphoma, low-dose radiotherapy
Eligibility Criteria
Inclusion Criteria:
- Pathology proved iNHL
- ECOG PS ≤3
- Signed Informed consent
Exclusion Criteria:
- History of radiotherapy at the same site
- Primary malignant lymphoma of the gastrointestinal tract
- CTV (Clinical Target Volume)>500ml
- Others that researchers consider inappropriate
Sites / Locations
- National Cancer Center/National Clinical Research Center for Cancer/Cancer Hospital, Chinese Academy of Medical Sciences and Peking Union Medical CollegeRecruiting
Arms of the Study
Arm 1
Arm Type
Experimental
Arm Label
Low-dose Radiotherapy
Arm Description
Involved-site radiotherapy (3 Gy*4f) in one week
Outcomes
Primary Outcome Measures
Rate of clinical complete response after radiotherapy
complete resolution of disease in imaging or biopsy after low-dose radiotherapy
Secondary Outcome Measures
Overall response rate after radiotherapy
complete or partial resolution of disease in imaging or biopsy after low-dose radiotherapy
Progression-free survival rate at year 2 after enrollment, 2y-PFS
From enrollment to any disease progression or death
Local control rate at year 2 after enrollment, 2y-LCR
From enrollment to any local disease progression or death
Rate of acute toxicity (any and above grade 3)
toxicities according to CTCAE criteria
Rate of late toxicity (any and above grade 3)
toxicities according to CTCAE criteria
Quality of Life change, QoL
measurement basing on EORTC-QLQ-C30 tables
Full Information
NCT ID
NCT05543070
First Posted
September 8, 2022
Last Updated
September 13, 2022
Sponsor
Chinese Academy of Medical Sciences
Collaborators
Shanxi Province Cancer Hospital, Beijing Tongren Hospital, Fujian Medical University Union Hospital
1. Study Identification
Unique Protocol Identification Number
NCT05543070
Brief Title
Low-dose Radiotherapy in iNHL
Official Title
Low-dose Radiotherapy in Indolent Lymphoma：A Multi-center Phase II Study
Study Type
Interventional
2. Study Status
Record Verification Date
September 2022
Overall Recruitment Status
Recruiting
Study Start Date
May 1, 2022 (Actual)
Primary Completion Date
July 1, 2024 (Anticipated)
Study Completion Date
January 1, 2025 (Anticipated)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Chinese Academy of Medical Sciences
Collaborators
Shanxi Province Cancer Hospital, Beijing Tongren Hospital, Fujian Medical University Union Hospital
4. Oversight
Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
Yes
5. Study Description
Brief Summary
The current study is a phase II multi-center single arm trial to evaluate the efficacy and safety of low-dose radiotherapy (3 Gy*4f) in indolent lymphoma.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Indolent Lymphoma, Low-dose Radiotherapy
Keywords
indolent lymphoma, low-dose radiotherapy
7. Study Design
Primary Purpose
Treatment
Study Phase
Phase 2
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
N/A
Enrollment
73 (Anticipated)
8. Arms, Groups, and Interventions
Arm Title
Low-dose Radiotherapy
Arm Type
Experimental
Arm Description
Involved-site radiotherapy (3 Gy*4f) in one week
Intervention Type
Radiation
Intervention Name(s)
Low-dose radiotherapy
Intervention Description
Electron Beam/3D-CRT/IMRT/VMAT
Primary Outcome Measure Information:
Title
Rate of clinical complete response after radiotherapy
Description
complete resolution of disease in imaging or biopsy after low-dose radiotherapy
Time Frame
6-month after radiotherapy
Secondary Outcome Measure Information:
Title
Overall response rate after radiotherapy
Description
complete or partial resolution of disease in imaging or biopsy after low-dose radiotherapy
Time Frame
6-month after radiotherapy
Title
Progression-free survival rate at year 2 after enrollment, 2y-PFS
Description
From enrollment to any disease progression or death
Time Frame
2-year
Title
Local control rate at year 2 after enrollment, 2y-LCR
Description
From enrollment to any local disease progression or death
Time Frame
2-year
Title
Rate of acute toxicity (any and above grade 3)
Description
toxicities according to CTCAE criteria
Time Frame
From enrollment to 3 months after treatment
Title
Rate of late toxicity (any and above grade 3)
Description
toxicities according to CTCAE criteria
Time Frame
After 3 months of enrollment
Title
Quality of Life change, QoL
Description
measurement basing on EORTC-QLQ-C30 tables
Time Frame
1/3/6/12/24 months after radiotherapy
Other Pre-specified Outcome Measures:
Title
Biomarkers to predict radiotherapy efficacy
Description
potential biomarkers in baseline tumor samples and blood samples
Time Frame
baseline/through study completion, an average of 1 year
Title
Conjunctival microbiota
Description
DNA samples from ocular adnexal extranodal MALT lymphoma patients' conjunctiva
Time Frame
baseline/4 fractions/1/3/6/12/24 months after radiotherapy
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
80 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria:
Pathology proved iNHL
ECOG PS ≤3
Signed Informed consent
Exclusion Criteria:
History of radiotherapy at the same site
Primary malignant lymphoma of the gastrointestinal tract
CTV (Clinical Target Volume)>500ml
Others that researchers consider inappropriate
Facility Information:
Facility Name
National Cancer Center/National Clinical Research Center for Cancer/Cancer Hospital, Chinese Academy of Medical Sciences and Peking Union Medical College
City
Beijing
State/Province
Beijing
ZIP/Postal Code
100021
Country
China
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Shunan Qi, MD
Phone
+861087788995
Email
medata@163.com
12. IPD Sharing Statement
Plan to Share IPD
Yes
IPD Sharing Plan Description
All IPD that underlie results in a publication
IPD Sharing Time Frame
From: 6 months after publication. To: 5 years after publication
IPD Sharing Access Criteria
Will share data with the PIs who had specific study plan in tumor sequencing analysis
Learn more about this trial
Low-dose Radiotherapy in iNHL
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