Clinical trial · Interventional
Efficacy of Palliative Low-Dose Involved-Field Radiation Therapy for Recurrent Advanced Follicular Lymphoma
A Prospective, Randomized, Open-label, Multi-center Study of Efficacy of Palliative Low-Dose Involved-Field Radiation Therapy for Recurrent Advanced Follicular Lymphoma: Wuhan University Cancer Center -NHL02 Trial
- Source
- ClinicalTrials.gov
- Retrieved
- Sep 8, 2026
- Layer
- normalized (units and labels harmonized; values unchanged)
- Run
- ING-CLINICALTRIALS-20260908-000001
Summary
Brief summary (as posted)
Many trials that patients with advanced or recurrent indolent lymphoma managed with very low-dose (4Gy) limited-field RT (LD-IFRT) have shown that high response rates and durable remission can be achieved. However, the results of two phase III trials have failed to demonstrate the lasting response rate (RR) with LD-IFRT versus in other approaches. Histology, bulky tumor (\>5 cm), higher number of prior chemotherapy regimens, adoption of rituximab, and age\>65 years have been shown to significantly influence response rates of LD-IFRT. The objectives of this trial investigate the efficacy of palliative low-dose involved-field radiation therapy in patients lower than 65 years of age with recurrent advanced follicular lymphoma.
Conditions
Conditions (1)
Free-text conditions as registered, with the CancerIndex entity they were reconciled to and the match type.
| Condition (as posted) | Mapped entity | Match | Confidence |
|---|---|---|---|
| Recurrent Follicular Lymphoma | Follicular Lymphoma | CURATED_BROADER | 0.78 |
Interventions
Interventions (2)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| Involved-field radiotherapy | Radiation | — | UNRESOLVED |
| Low-dose involved-field radiotherapy | Radiation | — | UNRESOLVED |
Design
Arms and outcomes
Arms (2)
- type
- EXPERIMENTAL
- label
- LD-IFRT group
- description
- Chemotherapy / Low-dose involved-field radiotherapy
- interventionNames
- Radiation: Low-dose involved-field radiotherapy
- type
- ACTIVE_COMPARATOR
- label
- IFRT group
- description
- Chemotherapy / Involved-field radiotherapy
- interventionNames
- Radiation: Involved-field radiotherapy
Primary outcomes (3)
- measure
- Overall response rates - ORR
- timeFrame
- At day 30 after radiotherapy
Eligibility
Eligibility (as posted)
- Sex
- All
- Minimum age
- 18 Years
- Maximum age
- 65 Years
Show eligibility criteria text
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 histological confirmed follicular lymphoma Grade 1 or 2. * Recurrent patient with stage III and IV after initial management. * Had the indications for treatment provided by GELA. * Rituximab is too expensive to be managed for the patient. * Adequate organ function. * Negative pregnancy test. * Signed informed consent document on file. Exclusion Criteria: * Woman who were pregnant or lactating. * Had uncontrolled metastases in central nervous system. * With severe local infection or general infective disease. * Immunotherapy for the treatment of follicular lymphoma within 1 month prior to the start of this trial. * With other second primary malignancy except cutaneum carcinoma. * Being or planing 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. * Continual consolidation chemotherapy after irradiation within the follow-up period. * In-field progression on irradiation ongoing. * Poor tolerability adverse events in the period of chemotherapy or irradiation after enrolled in the study.
References
Publications (0)
Data not yet available