Indolent Lymphoma Clinical Trial
Official title:
Low-dose Radiotherapy in Indolent Lymphoma:A Multi-center Phase II Study
Verified date | September 2022 |
Source | Chinese Academy of Medical Sciences |
Contact | n/a |
Is FDA regulated | No |
Health authority | |
Study type | Interventional |
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.
Status | Recruiting |
Enrollment | 73 |
Est. completion date | January 1, 2025 |
Est. primary completion date | July 1, 2024 |
Accepts healthy volunteers | No |
Gender | All |
Age group | 18 Years to 80 Years |
Eligibility | 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 |
Country | Name | City | State |
---|---|---|---|
China | National Cancer Center/National Clinical Research Center for Cancer/Cancer Hospital, Chinese Academy of Medical Sciences and Peking Union Medical College | Beijing | Beijing |
Lead Sponsor | Collaborator |
---|---|
Chinese Academy of Medical Sciences | Beijing Tongren Hospital, Fujian Medical University Union Hospital, Shanxi Province Cancer Hospital |
China,
Type | Measure | Description | Time frame | Safety issue |
---|---|---|---|---|
Other | Biomarkers to predict radiotherapy efficacy | potential biomarkers in baseline tumor samples and blood samples | baseline/through study completion, an average of 1 year | |
Other | Conjunctival microbiota | DNA samples from ocular adnexal extranodal MALT lymphoma patients' conjunctiva | baseline/4 fractions/1/3/6/12/24 months after radiotherapy | |
Primary | Rate of clinical complete response after radiotherapy | complete resolution of disease in imaging or biopsy after low-dose radiotherapy | 6-month after radiotherapy | |
Secondary | Overall response rate after radiotherapy | complete or partial resolution of disease in imaging or biopsy after low-dose radiotherapy | 6-month after radiotherapy | |
Secondary | Progression-free survival rate at year 2 after enrollment, 2y-PFS | From enrollment to any disease progression or death | 2-year | |
Secondary | Local control rate at year 2 after enrollment, 2y-LCR | From enrollment to any local disease progression or death | 2-year | |
Secondary | Rate of acute toxicity (any and above grade 3) | toxicities according to CTCAE criteria | From enrollment to 3 months after treatment | |
Secondary | Rate of late toxicity (any and above grade 3) | toxicities according to CTCAE criteria | After 3 months of enrollment | |
Secondary | Quality of Life change, QoL | measurement basing on EORTC-QLQ-C30 tables | 1/3/6/12/24 months after radiotherapy |
Status | Clinical Trial | Phase | |
---|---|---|---|
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