Low-dose Radiotherapy in iNHL

Phase 2

Recruiting

• Conditions: Low-dose Radiotherapy; Indolent Lymphoma
• Interventions: Radiation: Low-dose radiotherapy

• Registration Number: NCT05543070
• Lead Sponsor: Chinese Academy of Medical Sciences

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.

Detailed Description

Not available

Study Timeline

• Study Start: 2022-05-01
• Status Verified: 2022-09
• Study First Submitted: 2022-09-08
• Study First Submitted QC: 2022-09-13
• Last Update Submitted: 2022-09-13
• Study First Posted: 2022-09-16
• Last Update Posted: 2022-09-16
• Primary Completion: 2024-07-01
• Study Completion: 2025-01-01

Recruitment & Eligibility

• Status: RECRUITING
• Sex: All
• Target Recruitment: 73

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

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Arm && Interventions

Group	Intervention	Description
Low-dose Radiotherapy	Low-dose radiotherapy	Involved-site radiotherapy (3 Gy\*4f) in one week

Primary Outcome Measures

Name	Time	Method
Rate of clinical complete response after radiotherapy	6-month after radiotherapy	complete resolution of disease in imaging or biopsy after low-dose radiotherapy

Secondary Outcome Measures

Name	Time	Method
Overall response rate after radiotherapy	6-month after radiotherapy	complete or partial resolution of disease in imaging or biopsy after low-dose radiotherapy
Quality of Life change, QoL	1/3/6/12/24 months after radiotherapy	measurement basing on EORTC-QLQ-C30 tables
Progression-free survival rate at year 2 after enrollment, 2y-PFS	2-year	From enrollment to any disease progression or death
Rate of acute toxicity (any and above grade 3)	From enrollment to 3 months after treatment	toxicities according to CTCAE criteria
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

Trial Locations

Locations (1)

National Cancer Center/National Clinical Research Center for Cancer/Cancer Hospital, Chinese Academy of Medical Sciences and Peking Union Medical College; 🇨🇳 Beijing, Beijing, China