Efficacy of Consolidative Involved-site Radiotherapy Following Sufficient Chemotherapy for Patients With Limited-stage Diffuse Large B-cell Lymphoma: Wuhan University Cancer Center -NHL03 Trial

Who is this study for? Adult patients with diffuse large B-cell lymphoma
Status: Recruiting
Location: See location...
Intervention Type: Drug, Radiation
Study Type: Interventional
Study Phase: Phase 3
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.

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 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.

Locations
Other Locations
China
DiDeng
RECRUITING
Wuhan
Contact Information
Primary
Di Deng, MD
dengdi69@163.com
0086-27-67813153
Backup
Ping Chen, MD
zlk_cp@163.com
0086-13971911302
Time Frame
Start Date: 2015-10
Estimated Completion Date: 2025-10
Participants
Target number of participants: 160
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 maximal 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 paratial 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 maximal 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 paratial response beginning 1 month after the last cycle of chemotherapy.
Sponsors
Leads: Wuhan University

This content was sourced from clinicaltrials.gov

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