Low-dose Radiotherapy in iNHL

September 13, 2022 updated by: Shunan Qi, Cancer Institute and Hospital, Chinese Academy of Medical Sciences

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

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.

Study Overview

Status

Recruiting

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Anticipated)

73

Phase

  • Phase 2

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • China
    • Beijing
      • Beijing, Beijing, China, 100021
        • Recruiting
        • National Cancer Center/National Clinical Research Center for Cancer/Cancer Hospital, Chinese Academy of Medical Sciences and Peking Union Medical College
        • Contact:

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

16 years to 78 years (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

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 Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: N/A
  • Interventional Model: Single Group Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / 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

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Rate of clinical complete response after radiotherapy
Time Frame: 6-month after radiotherapy
complete resolution of disease in imaging or biopsy after low-dose radiotherapy
6-month after radiotherapy

Secondary Outcome Measures

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

Other Outcome Measures

Outcome Measure
Measure Description
Time Frame
Biomarkers to predict radiotherapy efficacy
Time Frame: baseline/through study completion, an average of 1 year
potential biomarkers in baseline tumor samples and blood samples
baseline/through study completion, an average of 1 year
Conjunctival microbiota
Time Frame: baseline/4 fractions/1/3/6/12/24 months after radiotherapy
DNA samples from ocular adnexal extranodal MALT lymphoma patients' conjunctiva
baseline/4 fractions/1/3/6/12/24 months after radiotherapy

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Cancer Institute and Hospital, Chinese Academy of Medical Sciences

Collaborators

Shanxi Province Cancer Hospital
Beijing Tongren Hospital
Fujian Medical University Union Hospital

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

May 1, 2022

Primary Completion (Anticipated)

July 1, 2024

Study Completion (Anticipated)

January 1, 2025

Study Registration Dates

First Submitted

September 8, 2022

First Submitted That Met QC Criteria

September 13, 2022

First Posted (Actual)

September 16, 2022

Study Record Updates

Last Update Posted (Actual)

September 16, 2022

Last Update Submitted That Met QC Criteria

September 13, 2022

Last Verified

September 1, 2022

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • CLCG-iNHL-01

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

Yes

IPD Plan Description

All IPD that underlie results in a publication

IPD Sharing Time Frame

From: 6 months after publication. To: 5 years after publication

IPD Sharing Access Criteria

Will share data with the PIs who had specific study plan in tumor sequencing analysis

IPD Sharing Supporting Information Type

  • Study Protocol
  • Statistical Analysis Plan (SAP)
  • Informed Consent Form (ICF)
  • Clinical Study Report (CSR)
  • Analytic Code

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

Clinical Trials on Indolent Lymphoma

Clinical Trials on Low-dose radiotherapy

Search Similar Trials

Sponsors and Collaborators

Medical Conditions

Drug Interventions

CROs by country

CROs in Mozambique

Conditions

Rare Diseases

Drug Interventions

Dietary Supplements

Sponsor/Collaborators

Locations

3
Subscribe