Low-dose Radiotherapy in iNHL

Sponsor

Chinese Academy of Medical Sciences (Other)

Overall Status

Recruiting

CT.gov ID

NCT05543070

Collaborator

Shanxi Province Cancer Hospital (Other), Beijing Tongren Hospital (Other), Fujian Medical University Union Hospital (Other)

Enrollment

Location

Arm

32.1

Anticipated Duration (Months)

2.3

Patients Per Site Per Month

Study Details

Study Description

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.

Condition or Disease	Intervention/Treatment	Phase
Indolent Lymphoma Low-dose Radiotherapy	Radiation: Low-dose radiotherapy	Phase 2

Study Design

Study Type:

Interventional

Anticipated Enrollment :

73 participants

Allocation:

N/A

Intervention Model:

Single Group Assignment

Masking:

None (Open Label)

Primary Purpose:

Treatment

Official Title:

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

Actual Study Start Date :

May 1, 2022

Anticipated Primary Completion Date :

Jul 1, 2024

Anticipated Study Completion Date :

Jan 1, 2025

Arms and Interventions

Arm	Intervention/Treatment
Experimental: Low-dose Radiotherapy Involved-site radiotherapy (3 Gy*4f) in one week	Radiation: Low-dose radiotherapy Electron Beam/3D-CRT/IMRT/VMAT

Arm

Intervention/Treatment

Experimental: Low-dose Radiotherapy

Involved-site radiotherapy (3 Gy*4f) in one week

Radiation: Low-dose radiotherapy

Electron Beam/3D-CRT/IMRT/VMAT

Outcome Measures

Primary Outcome Measures

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

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 acute toxicity (any and above grade 3) [From enrollment to 3 months after treatment]
toxicities according to CTCAE criteria
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

Other Outcome Measures

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

Eligibility Criteria

Criteria

Ages Eligible for Study:

18 Years to 80 Years

Sexes Eligible for Study:

All

Accepts Healthy Volunteers:

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

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
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	100021

Sponsors and Collaborators

Chinese Academy of Medical Sciences
Shanxi Province Cancer Hospital
Beijing Tongren Hospital
Fujian Medical University Union Hospital

Investigators

None specified.

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.

Responsible Party:

Shunan Qi, Associated Prof. in the radiation oncology department, Chinese Academy of Medical Sciences

ClinicalTrials.gov Identifier:

NCT05543070

Other Study ID Numbers:

CLCG-iNHL-01

First Posted:

Sep 16, 2022

Last Update Posted:

Sep 16, 2022

Last Verified:

Sep 1, 2022

Individual Participant Data (IPD) Sharing Statement:

Yes

Plan to Share IPD:

Yes

Studies a U.S. FDA-regulated Drug Product:

Studies a U.S. FDA-regulated Device Product:

Keywords provided by Shunan Qi, Associated Prof. in the radiation oncology department, Chinese Academy of Medical Sciences

indolent lymphoma

low-dose radiotherapy

Additional relevant MeSH terms:

Lymphoma

Study Results

No Results Posted as of Sep 16, 2022