Treatment of Aggressive Localized Lymphoma

This study is currently recruiting participants.
Verified October 2013 by Groupe Ouest Est d'Etude des Leucémies et Autres Maladies du Sang GOELAMS
Sponsor:
Information provided by (Responsible Party):
Groupe Ouest Est d'Etude des Leucémies et Autres Maladies du Sang GOELAMS
ClinicalTrials.gov Identifier:
NCT00841945
First received: February 11, 2009
Last updated: October 31, 2013
Last verified: October 2013
  Purpose

Prospective and multicentric Phase III study, evaluation of the interest of the radiotherapy after 4 or 6 cycles of CHOP 14 R regimen of chemotherapy , patients with agressive and localized B lymphoma , age 18 to 75 years.


Condition Intervention Phase
B Cell Lymphoma
Drug: rituximab
Drug: doxorubicin
Drug: vincristine
Drug: prednisone
Procedure: radiotherapy
Phase 3

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Parallel Assignment
Masking: Open Label
Primary Purpose: Treatment
Official Title: Phase III Study of the Interest of Radiotherapy After 4 or 6 Cycles of CHOP 14 Rituximab Regimen of Chemotherapy , Patients With Agressive Localized Lymphoma

Resource links provided by NLM:


Further study details as provided by Groupe Ouest Est d'Etude des Leucémies et Autres Maladies du Sang GOELAMS:

Primary Outcome Measures:
  • Event Free Survival (EFS) and Progression Free Survival (PFS) [ Time Frame: EFS PFS one year after treatment ] [ Designated as safety issue: Yes ]

Secondary Outcome Measures:
  • Pet-scan [ Time Frame: pronostic impact of Pet-scan ] [ Designated as safety issue: Yes ]
  • radiotherapy [ Time Frame: Toxicity of the radiotherapy ] [ Designated as safety issue: Yes ]

Estimated Enrollment: 400
Study Start Date: April 2005
Estimated Study Completion Date: June 2014
Primary Completion Date: October 2013 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Active Comparator: 1

Chemotherapy + Radiotherapy

- 4 or 6 R CHOP courses regimen every 14 days R CHOP = Rituximab, Doxorubicin, Vincristine and prednisone

  • Radiotherapy 40 gray on initial nodes
Drug: rituximab
RITUXIMAB 375 MG/M² IV DAY 1 or each course
Other Name: MABTHERA
Drug: doxorubicin
doxorubicin 50 mg / m² iv day 1 of each course
Other Name: Adriblastine
Drug: vincristine
VINCRISTINE 1?4 MG/M² IV ON DAY 1
Other Name: Oncovin
Drug: prednisone
Prednisone 40 mg/m² DAy 1 to day 5
Other Name: solupred
Procedure: radiotherapy
radiotherapy : total dose = 40 GY (5 fractions by week)
Other Name: no other name
Experimental: 2

Chemotherapy

- 4 or 6 R CHOP courses regimen every 14 days R CHOP = Rituximab, Doxorubicin, Vincristine and prednisone

Drug: rituximab
RITUXIMAB 375 MG/M² IV DAY 1 or each course
Other Name: MABTHERA
Drug: doxorubicin
doxorubicin 50 mg / m² iv day 1 of each course
Other Name: Adriblastine
Drug: vincristine
VINCRISTINE 1?4 MG/M² IV ON DAY 1
Other Name: Oncovin
Drug: prednisone
Prednisone 40 mg/m² DAy 1 to day 5
Other Name: solupred

Detailed Description:

CHOP 14 R regimen of chemotherapy is a good standard in the treatment of agressive and localized B lymphoma.

Interest of the radiotheraphy

  Eligibility

Ages Eligible for Study:   18 Years to 75 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • Age > 18 and < 75 years
  • Diffuse B large cell lymphoma , CD 20+
  • Ann Arbor stage I or II withe a bulk <7 cm
  • stage i ou II confirmed by the PET-scan
  • No previously treated
  • HIV negative
  • Signed Informed consent

Exclusion Criteria:

  • Age< 18 and > 75 years
  • other type of lymphoma
  • CD20 negative
  • Ann Arbor stage >II or bulk > 7 cm
  • HIV positive
  • Contraindication to Rituximab use according to Sm PC
  • Containdication to antracyclin
  • cancer or history of cancer , excepted in situ cancer of the cervix or skin epithelioma
  • Refusal of sign the informed consent
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT00841945

Contacts
Contact: Thierry LAMY, MD Ph D +33 2 99 28 42 91 thierry.lamy@univ-rennes1.fr

Locations
France
Regional university hospital Recruiting
Rennes, France, 35033
Contact: Thierry LAMY, MD PhD    + 33 2 99 28 42 91    thierry.lamy@univ-rennes1.fr   
Sponsors and Collaborators
Groupe Ouest Est d'Etude des Leucémies et Autres Maladies du Sang GOELAMS
Investigators
Principal Investigator: Thierry LAMY, MD PhD Groupe Ouest Est d'Etude des Leucémies et Autres Maladies du Sang GOELAMS
  More Information

Additional Information:
No publications provided

Responsible Party: Groupe Ouest Est d'Etude des Leucémies et Autres Maladies du Sang GOELAMS
ClinicalTrials.gov Identifier: NCT00841945     History of Changes
Other Study ID Numbers: GOELAMS 02 03
Study First Received: February 11, 2009
Last Updated: October 31, 2013
Health Authority: France: Afssaps - Agence française de sécurité sanitaire des produits de santé (Saint-Denis)

Keywords provided by Groupe Ouest Est d'Etude des Leucémies et Autres Maladies du Sang GOELAMS:
Diffuse B larg cell lymphoma
Chemotherapy
Radiotherapy

Additional relevant MeSH terms:
Lymphoma
Lymphoma, B-Cell
Neoplasms by Histologic Type
Neoplasms
Lymphoproliferative Disorders
Lymphatic Diseases
Immunoproliferative Disorders
Immune System Diseases
Lymphoma, Non-Hodgkin
Doxorubicin
Rituximab
Prednisone
Vincristine
Antibiotics, Antineoplastic
Antineoplastic Agents
Therapeutic Uses
Pharmacologic Actions
Glucocorticoids
Hormones
Hormones, Hormone Substitutes, and Hormone Antagonists
Physiological Effects of Drugs
Antineoplastic Agents, Hormonal
Anti-Inflammatory Agents
Tubulin Modulators
Antimitotic Agents
Mitosis Modulators
Molecular Mechanisms of Pharmacological Action
Antineoplastic Agents, Phytogenic
Immunologic Factors
Antirheumatic Agents

ClinicalTrials.gov processed this record on April 21, 2014