NCT05543070

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.

Trial Health

43
At Risk

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Trial has exceeded expected completion date
Enrollment
73

participants targeted

Target at P50-P75 for phase_2

Timeline
Completed

Started May 2022

Geographic Reach
1 country

1 active site

Status
unknown

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

May 1, 2022

Completed
4 months until next milestone

First Submitted

Initial submission to the registry

September 8, 2022

Completed
8 days until next milestone

First Posted

Study publicly available on registry

September 16, 2022

Completed
1.8 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

July 1, 2024

Completed
6 months until next milestone

Study Completion

Last participant's last visit for all outcomes

January 1, 2025

Completed
Last Updated

September 16, 2022

Status Verified

September 1, 2022

Enrollment Period

2.2 years

First QC Date

September 8, 2022

Last Update Submit

September 13, 2022

Conditions

Indolent LymphomaLow-dose Radiotherapy

Keywords

indolent lymphomalow-dose radiotherapy

Outcome Measures

Primary Outcomes (1)

  • Rate of clinical complete response after radiotherapy

    complete resolution of disease in imaging or biopsy after low-dose radiotherapy

    6-month after radiotherapy

Secondary Outcomes (6)

  • Overall response rate after radiotherapy

    6-month after radiotherapy

  • Progression-free survival rate at year 2 after enrollment, 2y-PFS

    2-year

  • Local control rate at year 2 after enrollment, 2y-LCR

    2-year

  • Rate of acute toxicity (any and above grade 3)

    From enrollment to 3 months after treatment

  • Rate of late toxicity (any and above grade 3)

    After 3 months of enrollment

  • +1 more secondary outcomes

Other Outcomes (2)

  • Biomarkers to predict radiotherapy efficacy

    baseline/through study completion, an average of 1 year

  • Conjunctival microbiota

    baseline/4 fractions/1/3/6/12/24 months after radiotherapy

Study Arms (1)

Low-dose Radiotherapy

EXPERIMENTAL

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

Radiation: Low-dose radiotherapy

Interventions

Low-dose radiotherapyRADIATION

Electron Beam/3D-CRT/IMRT/VMAT

Low-dose Radiotherapy

Eligibility Criteria

Age18 Years - 80 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • Pathology proved iNHL
  • ECOG PS ≤3
  • Signed Informed consent

You may not qualify if:

  • History of radiotherapy at the same site
  • Primary malignant lymphoma of the gastrointestinal tract
  • CTV (Clinical Target Volume)\>500ml
  • Others that researchers consider inappropriate

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

National Cancer Center/National Clinical Research Center for Cancer/Cancer Hospital, Chinese Academy of Medical Sciences and Peking Union Medical College

Beijing, Beijing Municipality, 100021, China

RECRUITING

Related Publications (2)

  • Wang XY, Zhang XM, Wang L, Gao LR, Chen K, Feng XL, Rao W, Zheng R, Wu YP, Song YW, Fang H, Chen B, Jin J, Liu YP, Jing H, Tang Y, Zhang WW, Zhai YR, Lu NN, Li N, Xia CF, Wang SL, Liu X, Li YX, Qi SN. Low-dose moderate hypofractionated radiotherapy for indolent non-Hodgkin lymphoma: a multicentre, single-arm, phase 2 trial. Lancet Haematol. 2025 Jun;12(6):e442-e450. doi: 10.1016/S2352-3026(25)00071-7. Epub 2025 May 2.

    PMID: 40324445DERIVED

  • Gao LR, Wang X, Xia C, Song YW, Wang L, Li X, Yang Y, Cao JZ, Chen K, Zhong QZ, Gao Y, Zhou SY, Feng XL, Wang X, Li YX, Qi SN. Multicenter phase II study of moderate low-dose radiotherapy in indolent non-Hodgkin lymphoma: CLCG-iNHL-01 protocol. Future Oncol. 2024 Jan;20(2):71-81. doi: 10.2217/fon-2023-0761. Epub 2024 Jan 5.

    PMID: 38179936DERIVED

MeSH Terms

Interventions

Radiotherapy

Intervention Hierarchy (Ancestors)

Therapeutics

Study Design

Study Type
interventional
Phase
phase 2
Allocation
NA
Masking
NONE
Purpose
TREATMENT
Intervention Model
SINGLE GROUP
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Associated Prof. in the radiation oncology department

Study Record Dates

First Submitted

September 8, 2022

First Posted

September 16, 2022

Study Start

May 1, 2022

Primary Completion

July 1, 2024

Study Completion

January 1, 2025

Last Updated

September 16, 2022

Record last verified: 2022-09

Data Sharing

IPD Sharing
Will share

All IPD that underlie results in a publication

Shared Documents
STUDY PROTOCOL, SAP, ICF, CSR, ANALYTIC CODE
Time Frame
From: 6 months after publication. To: 5 years after publication
Access Criteria
Will share data with the PIs who had specific study plan in tumor sequencing analysis

Locations

CN(1)