Multiple Fields Radiotherapy Versus Intravenous Rituximab in the Treatment of Indolent Cutaneous Lymphomas B-cell With Multiple or Recurrent Lesions (RADIO-LYMPH)
Primary Purpose
Indolent Cutaneous B Cell Lymphomas
Status
Unknown status
Phase
Phase 3
Locations
France
Study Type
Interventional
Intervention
rituximab
Multi-fields radiotherapy
Sponsored by
About this trial
This is an interventional treatment trial for Indolent Cutaneous B Cell Lymphomas
Eligibility Criteria
Inclusion Criteria:
- patients with histological diagnosis of indolent cutaneous B cell lymphomas
- patients with multiple lesions inaccessible to a single field of radiotherapy or patients with a recurrence outside the field of first radiotherapy
- patient with a lesion of at least 15 mm in major axis and a total tumor surface area greater or egal than 4 cm2
- patient with a negative staging
- patient consenting to participate to the study
- patient enrolled in the national healthcare insurance program
- patient older than 18 years
Exclusion Criteria:
- contraindication for rituximab or radiotherapy
- immunosuppressive therapy
- immunosuppression
Sites / Locations
- Chu de Reims
Arms of the Study
Arm 1
Arm 2
Arm Type
Experimental
Active Comparator
Arm Label
Rituximab by intravenous
multi-field radiotherapy
Arm Description
attack treatment (4 slow intravenous perfusions of rituximab at a dose of 375 mg / m2 on day 1, day 8, day 15 and day 22) and maintenance treatment (intravenous perfusions of rituximab at a dose of 375 mg / m2 every 2 months for 2 years).
multi-fields radiotherapy with a dose between 20 and 30 gray and a fractionated dose over 2 at 3 weeks.
Outcomes
Primary Outcome Measures
Disease free survival
Disease free survival
Secondary Outcome Measures
Full Information
1. Study Identification
Unique Protocol Identification Number
NCT02867553
Brief Title
Multiple Fields Radiotherapy Versus Intravenous Rituximab in the Treatment of Indolent Cutaneous Lymphomas B-cell With Multiple or Recurrent Lesions
Acronym
RADIO-LYMPH
Official Title
Multiple Fields Radiotherapy Versus Intravenous Rituximab in the Treatment of Indolent Cutaneous Lymphomas B-cell With Multiple or Recurrent Lesions
Study Type
Interventional
2. Study Status
Record Verification Date
September 2016
Overall Recruitment Status
Unknown status
Study Start Date
October 2011 (undefined)
Primary Completion Date
July 2018 (Anticipated)
Study Completion Date
January 2019 (Anticipated)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor
Name of the Sponsor
CHU de Reims
4. Oversight
5. Study Description
Brief Summary
Cutaneous lymphomas are the most frequent extranodal lymphomas after digestive lymphomas. A quarter are B-cell lymphomas. 80% of cutaneous B cell lymphomas are indolent cutaneous B cell lymphomas. These indolent cutaneous B cell lymphomas are characterized by good prognosis (survival rate at 5 years: 90%), but also by the frequency of cutaneous recurrences. The radiotherapy is currently the most widely used treatment, with complete response rate close to 100% for a lesion treated. However, it has limits when there are outset multiple lesions inaccessible to a single radiotherapy field (concerning one case in three), or during recurrences. In these situations, conventional chemotherapy is not recommended and multi-field radiotherapy is often used empirically, but its effectiveness has never been studied prospectively.
Recently, retrospective studies with small numbers patients (totaling sixty patients) reported complete response rates of 80 to 100% with rituximab (anti-cluster of differentiation antigen 20 (CD20) antibodies) used as monotherapy in non-standardized treatment by intravenous with a recurrence rate of less than one case in three. These data suggest that rituximab by intravenous with a standardized initial cycle followed by a maintenance therapy could improve the prognosis of indolent cutaneous B cell lymphomas with multiple lesions or of recurrent lesions.
Detailed Description
Compare the efficacy and safety of two treatment strategies for indolent cutaneous B cell lymphomas with multiple or recurrent lesions: Rituximab by intravenous versus multi-field radiotherapy.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Indolent Cutaneous B Cell Lymphomas
7. Study Design
Primary Purpose
Treatment
Study Phase
Phase 3
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Randomized
Enrollment
36 (Actual)
8. Arms, Groups, and Interventions
Arm Title
Rituximab by intravenous
Arm Type
Experimental
Arm Description
attack treatment (4 slow intravenous perfusions of rituximab at a dose of 375 mg / m2 on day 1, day 8, day 15 and day 22) and maintenance treatment (intravenous perfusions of rituximab at a dose of 375 mg / m2 every 2 months for 2 years).
Arm Title
multi-field radiotherapy
Arm Type
Active Comparator
Arm Description
multi-fields radiotherapy with a dose between 20 and 30 gray and a fractionated dose over 2 at 3 weeks.
Intervention Type
Drug
Intervention Name(s)
rituximab
Intervention Type
Radiation
Intervention Name(s)
Multi-fields radiotherapy
Primary Outcome Measure Information:
Title
Disease free survival
Description
Disease free survival
Time Frame
5 years
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria:
patients with histological diagnosis of indolent cutaneous B cell lymphomas
patients with multiple lesions inaccessible to a single field of radiotherapy or patients with a recurrence outside the field of first radiotherapy
patient with a lesion of at least 15 mm in major axis and a total tumor surface area greater or egal than 4 cm2
patient with a negative staging
patient consenting to participate to the study
patient enrolled in the national healthcare insurance program
patient older than 18 years
Exclusion Criteria:
contraindication for rituximab or radiotherapy
immunosuppressive therapy
immunosuppression
Facility Information:
Facility Name
Chu de Reims
City
Reims
ZIP/Postal Code
51092
Country
France
12. IPD Sharing Statement
Learn more about this trial
Multiple Fields Radiotherapy Versus Intravenous Rituximab in the Treatment of Indolent Cutaneous Lymphomas B-cell With Multiple or Recurrent Lesions
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