Efficacy of Consolidative Involved-site Radiotherapy for Patients With Limited-stage Follicular Lymphoma
1 other identifier
interventional
120
1 country
1
Brief Summary
Radiotherapy (RT) is an important option for patients with limited stage FL. The recommended approach for patients with limited stage FL by The National Comprehensive Cancer Network (NCCN) is 24Gy\~30Gy consolidation RT following effective systemic therapy. There is no universal consensus for a ''standard'' RT field size in the treatment of limited stage FL. The involved-site radiotherapy (ISRT) has been treated effectively for these patients. However, the certain target volumes of ISRT need to be defined for patients with limited stage FL after effective chemotherapy.
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
May 7, 2015
CompletedFirst Posted
Study publicly available on registry
May 20, 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
May 7, 2015
December 11, 2015
Conditions
Keywords
Outcome Measures
Primary Outcomes (2)
Progression-free survival - PFS
Treatment failure was defined as any recurrence of non-Hodgkin lymphoma.
from the date of diagnosis to the date of treatment failure or death from any cause, whichever occurs first, Assessed up to 100 months.
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 (4)
Overall survival - OS
From the initial diagnosis of follicular lymphoma to death from any cause, Assessed up to 120 months.
Rate of in-field progression
From the start of RT to the first documented disease progression within the radiotherapy field, Assessed up to 120 months.
Rate of out-field progression
From the start of RT to the first documented disease progression outside the radiotherapy field, Assessed up to 120 months.
Rate of regional failure
From the start of RT to the first documented disease progression outside of ISRT field but within the involved region defined as CALGB, Assessed up to 120 months.
Study Arms (2)
ISRT group
EXPERIMENTALSix cycles chemotherapy (cyclophosphamide 750mg/square meter on day 1 + doxorubicin 50mg/square meter on day 1 + vincristine 1.4mg/square meter on day 1 (up to a maxomal dose of 2 mg) + prednisone 60mg/square meter on day 1 through 5, repeated at 21-day intervals). Consolidation involved-site radiotherapy (ISRT) following in patients with complete or partial response beginning 1 month after the last cycle of chemotherapy.
IFRT group
ACTIVE COMPARATORSix cycles chemotherapy (cyclophosphamide 750mg/square meter on day 1 + doxorubicin 50mg/square meter on day 1 + vincristine 1.4mg/square meter on day 1 (up to a maxomal dose of 2 mg) + prednisone 60mg/square meter on day 1 through 5, repeated at 21-day intervals). Consolidation involved-field radiotherapy (IFRT) following in patients with complete or partial response beginning 1 month after the last cycle of chemotherapy.
Interventions
six cycles modern CHOP chemotherapy. Involved-site radiotherapy (ISRT) is based on defining the site of gross disease before chemotherapy, the GTV and using a CT-based volume with an expansion to form a CTV in the cranio-caudal direction. Involved-site radiotherapy (ISRT) is given in 24Gy\~30Gy in 12\~15 fractions of 2 Gy 5 days per week.
six cycles modern CHOP chemotherapy. Radiotherapy field of involved-field radiotherapy defined by CALGB is encompassed the prechemotherapy gross tumor. Involved-field RT (IFRT) is given in 24Gy\~30Gy in 12\~15 fractions of 2 Gy 5 days per week.
patients in both arms will be given cyclophosphamide chemotherapy.
patients in both arms will be given cyclophosphamide chemotherapy.
patients in both arms will be given cyclophosphamide chemotherapy.
patients in both arms will be given cyclophosphamide chemotherapy.
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 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.
You may not qualify if:
- 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.
Contact the study team to confirm eligibility.
Sponsors & Collaborators
- Wuhan Universitylead
Study Sites (1)
DiDeng
Wuhan, Hubei, 430071, China
MeSH Terms
Conditions
Interventions
Condition Hierarchy (Ancestors)
Intervention 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
- PRINCIPAL INVESTIGATOR
- PI Title
- Director, Clinical Research
Study Record Dates
First Submitted
May 7, 2015
First Posted
May 20, 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