Low-dose Radiotherapy in iNHL

Indolent Lymphoma Clinical Trial

Official title:

Low-dose Radiotherapy in Indolent Lymphoma：A Multi-center Phase II Study

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT05543070
• Other study ID #: CLCG-iNHL-01
• Status: Recruiting
• Phase: Phase 2
• 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
• 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

Related Conditions & MeSH terms

• Indolent Lymphoma
• Lymphoma

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