The Palliative Benefit of Involved-site Radiotherapy for Patients With Advanced-stage Diffuse Large B-cell Lymphoma
NCT ID: NCT02449278
Last Updated: 2015-12-14
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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RECRUITING
PHASE3
120 participants
INTERVENTIONAL
2015-10-31
2025-10-31
Brief Summary
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Detailed Description
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Some benefits of consolidation RT after chemotherapy exist for patients with advanced-stage DLBCL. One of the important aims of treatment for these patients is the improvement of event-free survival (EFS). After patients receive chemotherapy alone, the most common site of disease recurrence is at sites of initial disease involvement. The complications related to chemotherapy, including second malignancies and other non-neoplastic late events, were needed to emphasize for those patients managed with more cycles' regimens alone to increase the efficacy of patients with advanced-stage DLBCL. Receipt of consolidation RT was associated with improved in-field control and EFS though no difference in overall survival (OS) when compared to patients without consolidation RT. Several randomized and retrospective studies demonstrated that the EFS (even the OS) can be improved by consolidation RT for patients with advanced-stage DLBCL after CHOP or CHOP-like chemotherapy. The patients randomized among those diagnosed initially with bulky disease (\>10 cm), those achieving CR or PR after chemotherapy, and even those in stage IV with bone marrow involved.
The complications related to consolidation RT also need to be additionally explored for those patients since the efficacy of advanced-stage DLBCL has improved by combined-modality therapy (CMT). Especially, considerable difficulties in the continuous salvage options are unavoidable because of the risk of blood cell production disorders associated to extensive-field radiotherapy. Consolidation involved-field radiotherapy (IFRT) after effective chemotherapy is common palliative strategy for patients with advanced-stage DLBCL. The morbidity of treatment may be decreased further by RT with the radiation field size reduction. Involved-site radiotherapy (ISRT), based on a modified involved field, aims to reduce the radiation volume treated and the probability of late effects. Its radiation targets include a gross tumor volume (GTV), a clinical target volume (CTV), and a planning target volume (PTV), which were defined in International Commission on Radiation Units and Measurements Report (ICRU) 50. This 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. 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.
To evaluate the differences between IFRT and ISRT in the efficacy and complications related to consolidation RT for patients with advanced-stage DLBCL who achieved effective chemotherapy. The CTV of ISRT is defined as the region including the prechemotherapy volume of disease with 1.5 cm margin expanded cranio-caudally in the direction of potential lymphatic spread. The CTV should not extend into air in the transverse plane and should be limited in the involved lymph node region defined by the Cancer and Leukemia Group B (CALGB). The PTV is then extended from CTV by adding the necessary margin for setup error and organ motion.
Conditions
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Keywords
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Study Design
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RANDOMIZED
PARALLEL
TREATMENT
NONE
Study Groups
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ISRT group
Six 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.
Consolidation involved-site radiotherapy (ISRT)
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).
cyclophosphamide
Patients in both arms will be given cyclophosphamide chemotherapy
doxorubicin
Patients in both arms will be given doxorubicin chemotherapy
vincristine
Patients in both arms will be given vincristine chemotherapy
prednisone
Patients in both arms will be given prednisone chemotherapy
IFRT group
Six 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.
Consolidation involved-field radiotherapy (IFRT)
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).
cyclophosphamide
Patients in both arms will be given cyclophosphamide chemotherapy
doxorubicin
Patients in both arms will be given doxorubicin chemotherapy
vincristine
Patients in both arms will be given vincristine chemotherapy
prednisone
Patients in both arms will be given prednisone chemotherapy
Interventions
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Consolidation involved-site radiotherapy (ISRT)
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).
Consolidation involved-field radiotherapy (IFRT)
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).
cyclophosphamide
Patients in both arms will be given cyclophosphamide chemotherapy
doxorubicin
Patients in both arms will be given doxorubicin chemotherapy
vincristine
Patients in both arms will be given vincristine chemotherapy
prednisone
Patients in both arms will be given prednisone chemotherapy
Eligibility Criteria
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Inclusion Criteria
* 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
* 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.
18 Years
65 Years
ALL
No
Sponsors
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Wuhan University
OTHER
Responsible Party
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Di Deng
Director,Clinical Research
Locations
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DiDeng
Wuhan, Hubei, China
Countries
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Central Contacts
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Other Identifiers
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WUCC-NHL04 Trial
Identifier Type: -
Identifier Source: org_study_id