The Palliative Benefit of Involved-site Radiotherapy for Patients With Advanced-stage Diffuse Large B-cell Lymphoma
1 other identifier
interventional
120
1 country
1
Brief Summary
The standard treatment approach for patients with stage III-IV DLBCL is combination chemotherapy. Receipt of consolidation radiotherapy (RT) after effective chemotherapy was associated with improved in-field control and event-free survival. However, it is uncertain for the radiotherapy field size to treat for these patients after chemotherapy. Involved-field radiotherapy (IFRT) after effective chemotherapy is a common strategy for patients with stage III-IV DLBCL. There is not a clinical trial to research whether the sequential narrowed radiotherapy field size (involved-site radiotherapy, ISRT) can obtain the same efficacy as IFRT and decrease toxicities related to radiotherapy.
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
Click on a node to explore related trials.
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 60 months.
Rate of out-field progression
From the start of RT to the first documented disease progression outside the radiotherapy field, Assessed up to 60 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 60 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 maximal 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 patient with complete or partial response beginning 1 month after 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 maximal 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 patient with complete or partial response beginning 1 month after last cycle of chemotherapy.
Interventions
6 cycles modern CHOP chemotherapy followed consolidation involved-site radiotherapy (ISRT). 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. The general dose had been guided that 30-36Gy in 15\~18 fractions of 2 Gy 5 days per week was managed for patients with complete response (CR) after chemotherapy and 40-50Gy in 20\~25 fractions of 2 Gy 5 days per week for partial response (PR).
6 cycles modern CHOP chemotherapy followed consolidation involved-field radiotherapy (IFRT). Radiotherapy field of IFRT defined by CALGB is encompassed the prechemotherapy gross tumor. The general dose had been guided that 30-36Gy in 15\~18 fractions of 2 Gy 5 days per week was managed for patients with complete response (CR) after chemotherapy and 40-50Gy in 20\~25 fractions of 2 Gy 5 days per week for partial response (PR).
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 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.
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