NCT05543070
Recruiting
Phase 2
Low-dose Radiotherapy in Indolent Lymphoma：A Multi-center Phase II Study
Overview
- Phase
- Phase 2
- Intervention
- Not specified
- Conditions
- Indolent Lymphoma
- Sponsor
- Chinese Academy of Medical Sciences
- Enrollment
- 73
- Locations
- 1
- Primary Endpoint
- Rate of clinical complete response after radiotherapy
- Status
- Recruiting
- Last Updated
- 3 years ago
Overview
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.
Investigators
Shunan Qi
Associated Prof. in the radiation oncology department
Chinese Academy of Medical Sciences
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
Outcomes
Primary Outcomes
Rate of clinical complete response after radiotherapy
Time Frame: 6-month after radiotherapy
complete resolution of disease in imaging or biopsy after low-dose radiotherapy
Secondary Outcomes
- Overall response rate after radiotherapy(6-month after radiotherapy)
- Quality of Life change, QoL(1/3/6/12/24 months after radiotherapy)
- Progression-free survival rate at year 2 after enrollment, 2y-PFS(2-year)
- Rate of acute toxicity (any and above grade 3)(From enrollment to 3 months after treatment)
- Local control rate at year 2 after enrollment, 2y-LCR(2-year)
- Rate of late toxicity (any and above grade 3)(After 3 months of enrollment)
Study Sites (1)
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