Treatment of Aggressive Localized Lymphoma

This study has been completed.
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 3, 2014
Last verified: October 2014
  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 ]

Enrollment: 334
Study Start Date: April 2005
Study Completion Date: June 2014
Primary Completion Date: June 2014 (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
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT00841945

Locations
France
Regional university hospital
Rennes, France, 35033
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 3, 2014
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
Immune System Diseases
Immunoproliferative Disorders
Lymphatic Diseases
Lymphoma, Non-Hodgkin
Lymphoproliferative Disorders
Neoplasms
Neoplasms by Histologic Type
Doxorubicin
Liposomal doxorubicin
Prednisone
Rituximab
Vincristine
Anti-Inflammatory Agents
Antibiotics, Antineoplastic
Antimitotic Agents
Antineoplastic Agents
Antineoplastic Agents, Hormonal
Antineoplastic Agents, Phytogenic
Antirheumatic Agents
Enzyme Inhibitors
Glucocorticoids
Hormones
Hormones, Hormone Substitutes, and Hormone Antagonists
Immunologic Factors
Mitosis Modulators
Molecular Mechanisms of Pharmacological Action
Pharmacologic Actions
Physiological Effects of Drugs

ClinicalTrials.gov processed this record on October 21, 2014