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Clinical Trial Details — Status: Recruiting

Administrative data

NCT number NCT05543070
Other study ID # CLCG-iNHL-01
Secondary ID
Status Recruiting
Phase Phase 2
First received
Last updated
Start date May 1, 2022
Est. completion date January 1, 2025

Study information

Verified date September 2022
Source Chinese Academy of Medical Sciences
Contact n/a
Is FDA regulated No
Health authority
Study type Interventional

Clinical Trial 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.


Recruitment information / eligibility

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

Study Design


Related Conditions & MeSH terms


Intervention

Radiation:
Low-dose radiotherapy
Electron Beam/3D-CRT/IMRT/VMAT

Locations

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

Sponsors (4)

Lead Sponsor Collaborator
Chinese Academy of Medical Sciences Beijing Tongren Hospital, Fujian Medical University Union Hospital, Shanxi Province Cancer Hospital

Country where clinical trial is conducted

China, 

Outcome

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
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