A Prospective, Randomized, Open-label, Multi-center Study of Efficacy of Palliative Low-Dose Involved-Field Radiation Therapy for Recurrent Advanced Follicular Lymphoma: Wuhan University Cancer Center -NHL02 Trial

Who is this study for? Patients with Recurrent Follicular Lymphoma
What treatments are being studied? Involved-Field Radiotherapy
Status: Recruiting
Location: See location...
Intervention Type: Radiation
Study Type: Interventional
Study Phase: Phase 3
SUMMARY

Many trials that patients with advanced or recurrent indolent lymphoma managed with very low-dose (4Gy) limited-field RT (LD-IFRT) have shown that high response rates and durable remission can be achieved. However, the results of two phase III trials have failed to demonstrate the lasting response rate (RR) with LD-IFRT versus in other approaches. Histology, bulky tumor (\>5 cm), higher number of prior chemotherapy regimens, adoption of rituximab, and age\>65 years have been shown to significantly influence response rates of LD-IFRT. The objectives of this trial investigate the efficacy of palliative low-dose involved-field radiation therapy in patients lower than 65 years of age with recurrent advanced follicular lymphoma.

Eligibility
Participation Requirements
Sex: All
Minimum Age: 18
Maximum Age: 65
Healthy Volunteers: f
View:

• 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 histological confirmed follicular lymphoma Grade 1 or 2.

• Recurrent patient with stage III and IV after initial management.

• Had the indications for treatment provided by GELA.

• Rituximab is too expensive to be managed for the patient.

• Adequate organ function.

• Negative pregnancy test.

• Signed informed consent document on file.

Locations
Other Locations
China
DiDeng
RECRUITING
Wuhan
Contact Information
Primary
Di Deng, MD
dengdi69@163.com
0086-27-67813153
Backup
Liyong Zou, MD
zouliyong@csco.org.cn
0086-18908601687
Time Frame
Start Date: 2015-10
Estimated Completion Date: 2025-10
Participants
Target number of participants: 166
Treatments
Experimental: LD-IFRT group
Chemotherapy / Low-dose involved-field radiotherapy
Active_comparator: IFRT group
Chemotherapy / Involved-field radiotherapy
Sponsors
Leads: Di Deng

This content was sourced from clinicaltrials.gov

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