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The Palliative Benefit of Involved-site Radiotherapy for Patients With Advanced-stage Diffuse Large B-cell Lymphoma

NCT02449278 · Status: RECRUITING · Phase: PHASE3 · Type: INTERVENTIONAL · Enrollment: 120

Last updated 2015-12-14

No results posted yet for this study

Summary

The standard treatment approach for patients with stage III-IV DLBCL is combination chemotherapy. Receipt of consolidation radiotherapy (RT) after effective chemotherapy was associated with improved in-field control and event-free survival. However, it is uncertain for the radiotherapy field size to treat for these patients after chemotherapy. Involved-field radiotherapy (IFRT) after effective chemotherapy is a common strategy for patients with stage III-IV DLBCL. There is not a clinical trial to research whether the sequential narrowed radiotherapy field size (involved-site radiotherapy, ISRT) can obtain the same efficacy as IFRT and decrease toxicities related to radiotherapy.

Conditions

  • Diffuse Large B-cell Lymphoma

Interventions

RADIATION

Consolidation involved-site radiotherapy (ISRT)

6 cycles modern CHOP chemotherapy followed consolidation involved-site radiotherapy (ISRT). Involved-site radiotherapy (ISRT) is based on defining the site of gross disease before chemotherapy, the GTV and using a CT-based volume with an expansion to form a CTV in the cranio-caudal direction. The general dose had been guided that 30-36Gy in 15\~18 fractions of 2 Gy 5 days per week was managed for patients with complete response (CR) after chemotherapy and 40-50Gy in 20\~25 fractions of 2 Gy 5 days per week for partial response (PR).

RADIATION

Consolidation involved-field radiotherapy (IFRT)

6 cycles modern CHOP chemotherapy followed consolidation involved-field radiotherapy (IFRT). Radiotherapy field of IFRT defined by CALGB is encompassed the prechemotherapy gross tumor. The general dose had been guided that 30-36Gy in 15\~18 fractions of 2 Gy 5 days per week was managed for patients with complete response (CR) after chemotherapy and 40-50Gy in 20\~25 fractions of 2 Gy 5 days per week for partial response (PR).

DRUG

cyclophosphamide

Patients in both arms will be given cyclophosphamide chemotherapy

DRUG

doxorubicin

Patients in both arms will be given doxorubicin chemotherapy

DRUG

vincristine

Patients in both arms will be given vincristine chemotherapy

DRUG

prednisone

Patients in both arms will be given prednisone chemotherapy

Sponsors & Collaborators

  • Wuhan University

    lead OTHER

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Model
PARALLEL

Eligibility

Min Age
18 Years
Max Age
65 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2015-10-31
Primary Completion
2019-10-31
Completion
2025-10-31

Countries

  • China

Study Locations

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Entities

Drugs

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT02449278 on ClinicalTrials.gov