Efficacy of Consolidative Involved-site Radiotherapy for Patients With Limited-stage Diffuse Large B-cell Lymphoma

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

Summary

The most common option of radiotherapy for patients with limited-stage DLBCL is involved-field radiotherapy (IFRT). The more limited radiotherapy field size changing from IFRT to reasonable margin from gross tumor has been reported to maintain the high rates of local disease control, while minimizing the risks of radiation-induced toxicities. However, the research didn't analyze whether the efficacy of consolidation involved-site radiotherapy (ISRT) be affected by the response of chemotherapy. The biologic definition of clinical target volume (CTV) of ISRT and actual radiotherapy field size need to be ascertained.

• 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 Diffuse large B-cell lymphoma.

• Limited-stage DLBCL 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.