Efficacy of Consolidative Involved-site Radiotherapy Following Effective Chemotherapy for Patients With Limited-stage Follicular Lymphoma: Wuhan University Cancer Center -NHL01 Trial

Who is this study for? Patients with Follicular Lymphoma
What treatments are being studied? Consolidation Involved-Site Radiotherapy (ISRT)+Cyclophosphamide+Doxorubicin+Vincristine+Prednisone
Status: Recruiting
Location: See location...
Intervention Type: Radiation, Drug
Study Type: Interventional
Study Phase: Phase 3
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.

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 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.

Locations
Other Locations
China
DiDeng
RECRUITING
Wuhan
Contact Information
Primary
Di Deng, MD
dengdi69@163.com
0086-27-67813153
Backup
Ruizhi Ran, MD
rrz1966@126.com
0086-718-8295535
Time Frame
Start Date: 2015-10
Estimated Completion Date: 2025-10
Participants
Target number of participants: 120
Treatments
Experimental: ISRT group
Six cycles chemotherapy (cyclophosphamide 750mg/square meter on day 1 + doxorubicin 50mg/square meter on day 1 + vincristine 1.4mg/square meter on day 1 (up to a maxomal dose of 2 mg) + prednisone 60mg/square meter on day 1 through 5, repeated at 21-day intervals).~Consolidation involved-site radiotherapy (ISRT) following in patients with complete or partial response beginning 1 month after the last cycle of chemotherapy.
Active_comparator: IFRT group
Six cycles chemotherapy (cyclophosphamide 750mg/square meter on day 1 + doxorubicin 50mg/square meter on day 1 + vincristine 1.4mg/square meter on day 1 (up to a maxomal dose of 2 mg) + prednisone 60mg/square meter on day 1 through 5, repeated at 21-day intervals).~Consolidation involved-field radiotherapy (IFRT) following in patients with complete or partial response beginning 1 month after the last cycle of chemotherapy.
Sponsors
Leads: Wuhan University

This content was sourced from clinicaltrials.gov