Effectiveness of targeted radiotherapy for limited-stage follicular lymphoma
Efficacy of Consolidative Involved-site Radiotherapy Following Effective Chemotherapy for Patients With Limited-stage Follicular Lymphoma: Wuhan University Cancer Center -NHL01 Trial
This study is testing if a specific type of targeted radiotherapy can help people with early-stage follicular lymphoma live longer and stay cancer-free after their initial treatment.
Quick facts
| Phase | Phase 3 |
|---|---|
| Study type | Interventional |
| Enrollment | 120 (estimated) |
| Ages | 18 Years to 65 Years |
| Sex | All |
| Sponsor | Wuhan University Academic / other |
| Drugs / interventions | chemotherapy, immunotherapy, radiation |
| Locations | 1 site (Wuhan, Hubei) |
| Trial ID | NCT02449252 on ClinicalTrials.gov |
What this trial studies
This clinical trial evaluates the efficacy of consolidative involved-site radiotherapy (ISRT) for patients diagnosed with limited-stage follicular lymphoma (FL) after receiving effective systemic therapy. The study aims to define optimal target volumes for ISRT, which is recommended by the National Comprehensive Cancer Network as a treatment option. Participants will receive ISRT or involved-field radiotherapy (IFRT) in conjunction with chemotherapy agents such as cyclophosphamide, doxorubicin, and vincristine. The trial seeks to improve overall survival and disease-free survival rates for patients with this indolent form of lymphoma.
Who should consider this trial
Good fit: Ideal candidates include males and females aged 18 to 65 with histologically confirmed grade 1 or 2 follicular lymphoma at limited stage.
Not a fit: Patients with severe infections, other malignancies, or those who are pregnant or lactating may not benefit from this study.
Why it matters
Potential benefit: If successful, this approach could enhance survival rates and reduce recurrence in patients with limited-stage follicular lymphoma.
How similar studies have performed: Previous studies have shown positive outcomes with similar radiotherapy approaches, indicating potential for success in this trial.
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 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. 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.