Multiple Fields Radiotherapy Versus Intravenous Rituximab in the Treatment of Indolent Cutaneous Lymphomas B-cell With Multiple or Recurrent Lesions (RADIO-LYMPH)

September 6, 2016 updated by: CHU de Reims

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.

Study Overview

Status

Unknown

Conditions

Intervention / Treatment

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.

Study Type

Interventional

Enrollment (Actual)

36

Phase

  • Phase 3

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • France
      • Reims, France, 51092
        • CHU de Reims

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: Rituximab by intravenous
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).
Drug: rituximab
Active Comparator: multi-field radiotherapy
multi-fields radiotherapy with a dose between 20 and 30 gray and a fractionated dose over 2 at 3 weeks.
Radiation: Multi-fields radiotherapy

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Disease free survival
Time Frame: 5 years
Disease free survival
5 years

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

CHU de Reims

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

October 1, 2011

Primary Completion (Anticipated)

July 1, 2018

Study Completion (Anticipated)

January 1, 2019

Study Registration Dates

First Submitted

August 11, 2016

First Submitted That Met QC Criteria

August 11, 2016

First Posted (Estimate)

August 16, 2016

Study Record Updates

Last Update Posted (Estimate)

September 7, 2016

Last Update Submitted That Met QC Criteria

September 6, 2016

Last Verified

September 1, 2016

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • PN09001

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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