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Efficacy of Consolidative Involved-site Radiotherapy for Patients With Limited-stage Follicular Lymphoma

NCT02449252 · Status: RECRUITING · Phase: PHASE3 · Type: INTERVENTIONAL · Enrollment: 120

Last updated 2015-12-14

No results posted yet for this study

Summary

Radiotherapy (RT) is an important option for patients with limited stage FL. The recommended approach for patients with limited stage FL by The National Comprehensive Cancer Network (NCCN) is 24Gy\~30Gy consolidation RT following effective systemic therapy. There is no universal consensus for a ''standard'' RT field size in the treatment of limited stage FL. The involved-site radiotherapy (ISRT) has been treated effectively for these patients. However, the certain target volumes of ISRT need to be defined for patients with limited stage FL after effective chemotherapy.

Conditions

Interventions

RADIATION

Consolidation involved-site radiotherapy (ISRT)

six cycles modern CHOP chemotherapy. 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. Involved-site radiotherapy (ISRT) is given in 24Gy\~30Gy in 12\~15 fractions of 2 Gy 5 days per week.

RADIATION

Consolidation involved-field radiotherapy (IFRT)

six cycles modern CHOP chemotherapy. Radiotherapy field of involved-field radiotherapy defined by CALGB is encompassed the prechemotherapy gross tumor. Involved-field RT (IFRT) is given in 24Gy\~30Gy in 12\~15 fractions of 2 Gy 5 days per week.

DRUG

cyclophosphamide

patients in both arms will be given cyclophosphamide chemotherapy.

DRUG

doxorubicin

patients in both arms will be given cyclophosphamide chemotherapy.

DRUG

vincristine

patients in both arms will be given cyclophosphamide chemotherapy.

DRUG

prednisone

patients in both arms will be given cyclophosphamide 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
Diseases

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 NCT02449252 on ClinicalTrials.gov