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

• Status: Recruiting
• Trial end date: 2025-10-01
• Target enrollment: 0
• Participant gender: All

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.

• Phase: Phase 3
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: Wuhan University
• Treatments: Cyclophosphamide; Doxorubicin; Liposomal doxorubicin; Prednisone; Vincristine

Criteria

Inclusion Criteria:

• Both male and female aged range from 18 years to 65 years.

• Eastern Cooperative Oncology Group(ECOG) performance status of 0 or 1.

• All patients had histologically confirmed Follicular lymphoma, grade 1 or 2.

• Limited-stage FL patients at newly diagnosed or recurrent without RT in initial management.

• Adequate organ function.

• Negative pregnancy test.

• Signed informed consent document on file.

Exclusion Criteria:

• Woman who were pregnant or lactating.

• With severe local infection or general infective disease.

• Primary lymphoma in special organ including cuticula, center never system, gastrointestinal tract, testicle, and lung.

• With other second primary malignancy except cutaneum carcinoma.

• Being or planning to participate in other study.

• Any patient who in the opinion of the investigator should not participate in the study.

Withdrawal Criteria:

• Patient are free to withdrawal completely from the study at any time upon request.

• Patient in the study may be stopped with the patient agreement at any time at the discretion of investigator.

• In-field progression on irradiation ongoing.

• Poor tolerability adverse events in the period of chemotherapy or irradiation after enrolled in the study.