Efficacy of Palliative Low-Dose Involved-Field Radiation Therapy for Recurrent Advanced Follicular Lymphoma
WUCC-NHL02
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
1 other identifier
interventional
166
1 country
1
Brief Summary
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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P25-P50 for phase_3
Started Oct 2015
Longer than P75 for phase_3
1 active site
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
First Submitted
Initial submission to the registry
April 27, 2015
CompletedFirst Posted
Study publicly available on registry
May 8, 2015
CompletedStudy Start
First participant enrolled
October 1, 2015
CompletedPrimary Completion
Last participant's last visit for primary outcome
October 1, 2019
CompletedStudy Completion
Last participant's last visit for all outcomes
October 1, 2025
CompletedDecember 14, 2015
December 1, 2015
4 years
April 27, 2015
December 11, 2015
Conditions
Keywords
Outcome Measures
Primary Outcomes (3)
Overall response rates - ORR
At day 30 after radiotherapy
Time to treatment failure - TTF
From the start of radiotherapy to the first documented disease progression or death from any cause, whichever occurs first, Assessed up to 40 months.
Number of participants with adverse events with grade 3 or 4 - AEs
Toxicity was scored according to the toxicity scale of the National Cancer Institute Common Terminology Criteria for Adverse Events 3.0.
The time from the day of treatment to the day of the first documented disease progression or death from any cause, Assessed up to 24 months.
Secondary Outcomes (3)
Overall survival - OS
From the initial diagnosis of follicular lymphoma to death from any cause, Assessed up to 100 months.
Rate of in-field progression
From the start of RT to the first documented disease progression within the radiotherapy portal, Assessed up to 24 months.
Rate of out-field progression
From the start of RT to the first documented disease progression outside the radiotherapy field, Assessed up to 40 months.
Study Arms (2)
LD-IFRT group
EXPERIMENTALChemotherapy / Low-dose involved-field radiotherapy
IFRT group
ACTIVE COMPARATORChemotherapy / Involved-field radiotherapy
Interventions
Low-dose involved-field RT (LD-IFRT) is given in 2 daily fractions (2Ă—2 Gy). Involved-field of radiotherapy defined by CALGB is encompassed the prechemotherapy gross tumor.
Involved-field RT (IFRT) is given in 24 Gy in 12 fractions. Radiotherapy field defined by CALGB is encompassed the prechemotherapy gross tumor.
Eligibility Criteria
You may qualify if:
- 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.
You may not qualify if:
- 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.
Contact the study team to confirm eligibility.
Sponsors & Collaborators
- Di Denglead
Study Sites (1)
DiDeng
Wuhan, Hubei, 430071, China
MeSH Terms
Conditions
Condition Hierarchy (Ancestors)
Central Study Contacts
Study Design
- Study Type
- interventional
- Phase
- phase 3
- Allocation
- RANDOMIZED
- Masking
- NONE
- Purpose
- TREATMENT
- Intervention Model
- PARALLEL
- Sponsor Type
- OTHER
- Responsible Party
- SPONSOR INVESTIGATOR
- PI Title
- Associate Professor, Director of Research
Study Record Dates
First Submitted
April 27, 2015
First Posted
May 8, 2015
Study Start
October 1, 2015
Primary Completion
October 1, 2019
Study Completion
October 1, 2025
Last Updated
December 14, 2015
Record last verified: 2015-12