Indolent Lymphoma, Low-dose Radiotherapy
Conditions
Keywords
indolent lymphoma, low-dose radiotherapy
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.
Interventions
RADIATIONLow-dose radiotherapy
Electron Beam/3D-CRT/IMRT/VMAT
Sponsors
Shanxi Province Cancer Hospital
Beijing Tongren Hospital
Fujian Medical University Union Hospital
Chinese Academy of Medical Sciences
Study design
Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
TREATMENT
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
18 Years to 80 Years
Healthy volunteers
No
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
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Rate of clinical complete response after radiotherapy | 6-month after radiotherapy | complete resolution of disease in imaging or biopsy after low-dose radiotherapy |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Overall response rate after radiotherapy | 6-month 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 | 2-year | From enrollment to any disease progression or death |
| Local control rate at year 2 after enrollment, 2y-LCR | 2-year | From enrollment to any local disease progression or death |
| Rate of late toxicity (any and above grade 3) | After 3 months of enrollment | toxicities according to CTCAE criteria |
| Quality of Life change, QoL | 1/3/6/12/24 months after radiotherapy | measurement basing on EORTC-QLQ-C30 tables |
| Rate of acute toxicity (any and above grade 3) | From enrollment to 3 months after treatment | toxicities according to CTCAE criteria |
Other
| Measure | Time frame | Description |
|---|---|---|
| Biomarkers to predict radiotherapy efficacy | baseline/through study completion, an average of 1 year | potential biomarkers in baseline tumor samples and blood samples |
| Conjunctival microbiota | baseline/4 fractions/1/3/6/12/24 months after radiotherapy | DNA samples from ocular adnexal extranodal MALT lymphoma patients' conjunctiva |
Countries
China
Outcome results
None listed