Evaluating the benefits of targeted radiotherapy for advanced-stage lymphoma patients
The Palliative Benefit of Involved-site Radiotherapy Following Effective Chemotherapy for Patients With Advanced-stage Diffuse Large B-cell Lymphoma: Wuhan University Cancer Center - NHL04 Trial
This study is testing if a new type of targeted radiotherapy can help people with advanced-stage lymphoma feel better while causing fewer side effects than the standard 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, radiation |
| Locations | 1 site (Wuhan, Hubei) |
| Trial ID | NCT02449278 on ClinicalTrials.gov |
What this trial studies
This clinical trial investigates the effectiveness of involved-site radiotherapy (ISRT) compared to involved-field radiotherapy (IFRT) in patients with advanced-stage diffuse large B-cell lymphoma (DLBCL) who have undergone chemotherapy. The study aims to determine if ISRT can provide similar efficacy to IFRT while reducing the associated toxicities of radiotherapy. Patients aged 18 to 65 with confirmed DLBCL and adequate organ function will be enrolled, and their responses to treatment will be monitored to assess event-free survival and in-field control. The trial is designed to clarify the optimal radiotherapy approach for this patient population.
Who should consider this trial
Good fit: Ideal candidates are males and females aged 18 to 65 with histologically confirmed advanced-stage DLBCL who have not received radiotherapy in their initial management.
Not a fit: Patients who are pregnant, have severe infections, or have primary lymphoma in specific organs may not benefit from this study.
Why it matters
Potential benefit: If successful, this study could lead to a more effective and less toxic radiotherapy option for patients with advanced-stage DLBCL.
How similar studies have performed: While there is existing research on radiotherapy approaches for DLBCL, this specific comparison of ISRT versus IFRT is novel and has not been extensively tested.
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. * Advanced-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.