Effect of targeted radiotherapy on limited-stage diffuse large B-cell lymphoma
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
This study is testing if adding targeted radiotherapy to chemotherapy can help people with early-stage diffuse large B-cell lymphoma control their disease better while reducing side effects.
Quick facts
| Phase | Phase 3 |
|---|---|
| Study type | Interventional |
| Enrollment | 160 (estimated) |
| Ages | 18 Years to 65 Years |
| Sex | All |
| Sponsor | Wuhan University Academic / other |
| Drugs / interventions | chemotherapy, radiation, cyclophosphamide, doxorubicin, prednisone |
| Locations | 1 site (Wuhan, Hubei) |
| Trial ID | NCT02449265 on ClinicalTrials.gov |
What this trial studies
This clinical trial investigates the efficacy of consolidation involved-site radiotherapy (ISRT) for patients with limited-stage diffuse large B-cell lymphoma (DLBCL). It aims to determine whether ISRT, when combined with chemotherapy, can effectively control the disease while minimizing radiation-induced toxicities. The study will assess the appropriate chemotherapy cycles needed to maintain treatment efficacy and evaluate the biological definition of the clinical target volume for ISRT. Participants will receive a combination of chemotherapy and radiotherapy tailored to their specific disease stage.
Who should consider this trial
Good fit: Ideal candidates are adults aged 18 to 65 with histologically confirmed limited-stage DLBCL who have not received prior radiotherapy.
Not a fit: Patients with primary lymphoma in special organs or those with severe infections may not benefit from this study.
Why it matters
Potential benefit: If successful, this study could improve treatment outcomes and reduce side effects for patients with limited-stage DLBCL.
How similar studies have performed: Previous studies have shown mixed results regarding the efficacy of radiotherapy in similar patient populations, indicating that this approach is still being explored.
Eligibility criteria
Show full inclusion / exclusion 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.
Where this trial is running
Wuhan, Hubei
- DiDeng — Wuhan, Hubei, China (Recruiting)
Study contacts
- Study coordinator: Di Deng, MD
- Email: dengdi69@163.com
- Phone: 0086-27-67813153
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.