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Combination Chemotherapy in Treating Older Patients With Non-Hodgkin's Lymphoma

Primary Purpose

Lymphoma

Status
Completed
Phase
Phase 2
Locations
International
Study Type
Interventional
Intervention
cyclophosphamide
prednisone
vincristine sulfate
radiation therapy
Sponsored by
European Organisation for Research and Treatment of Cancer - EORTC
About
Eligibility
Locations
Outcomes
Full info

About this trial

This is an interventional treatment trial for Lymphoma focused on measuring stage I adult diffuse large cell lymphoma, stage III adult diffuse large cell lymphoma, stage IV adult diffuse large cell lymphoma, contiguous stage II adult diffuse large cell lymphoma, noncontiguous stage II adult diffuse large cell lymphoma, angioimmunoblastic T-cell lymphoma

Eligibility Criteria

70 Years - undefined (Older Adult)All SexesDoes not accept healthy volunteers

DISEASE CHARACTERISTICS: Diagnosis of diffuse large B-cell or peripheral T-cell non-Hodgkin's lymphoma (NHL) No Burkitt's-like lymphoma Small cells in bone marrow allowed Previously untreated NHL At least 1 measurable lesion At least 1.1 cm Poor physiological status with at least 1 of the following: WHO performance status of 3-4 LVEF less than 50% Creatinine clearance less than 50 mL/min Neutrophil count no greater than 1,500/mm^3 Platelet count no greater than 100,000/mm^3 Concurrent severe disease that would preclude cyclophosphamide, vincristine, prednisolone, and doxorubicin No cerebral or meningeal involvement PATIENT CHARACTERISTICS: Age: 70 and over Performance status: See Disease Characteristics Life expectancy: Not specified Hematopoietic: See Disease Characteristics Hepatic: Not specified Renal: See Disease Characteristics Other: HIV negative No other malignancy within the past 5 years except adequately treated basal cell skin cancer, curatively treated carcinoma in situ of the cervix, or curatively treated solid tumor No active infection No psychological, familial, sociological, or geographical condition that would preclude study participation PRIOR CONCURRENT THERAPY: Biologic therapy: Not specified Chemotherapy: See Disease Characteristics Endocrine therapy: Not specified Radiotherapy: Not specified Surgery: Not specified Other: No other concurrent investigational drugs No other concurrent antineoplastic agents

Sites / Locations

  • Ziekenhuis Network Antwerpen Middelheim
  • Centre Hospitalier Universitaire Brugmann
  • U.Z. Gasthuisberg
  • National Cancer Institute of Egypt
  • Centre D'Oncologie Du Pays-Basque
  • Hopital Saint Andre
  • Institut Bergonie
  • Centre Hospitalier de Dax
  • Hopital Robert Boulin
  • Polyclinique de Francheville
  • Onze Lieve Vrouwe Gasthuis
  • Academisch Ziekenhuis Groningen
  • University Medical Center Nijmegen
  • Hospitais da Universidade de Coimbra (HUC)
  • Hopitaux Universitaires de Geneve
  • New Cross Hospital
  • Dumfries Royal Infirmary

Outcomes

Primary Outcome Measures

Secondary Outcome Measures

Full Information

First Posted
June 6, 2002
Last Updated
September 20, 2012
Sponsor
European Organisation for Research and Treatment of Cancer - EORTC
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1. Study Identification

Unique Protocol Identification Number
NCT00039351
Brief Title
Combination Chemotherapy in Treating Older Patients With Non-Hodgkin's Lymphoma
Official Title
Diffuse Large B Cell And Peripheral T-Cell Non-Hodgkin's Lymphoma In The Frail Elderly. Progressive And Cautious Treatment Strategy In Poor Status Patients. A Phase II Trial With Emphasis On Geriatric Assessment And Quality Of Life
Study Type
Interventional

2. Study Status

Record Verification Date
September 2012
Overall Recruitment Status
Completed
Study Start Date
March 2002 (undefined)
Primary Completion Date
January 2005 (Actual)
Study Completion Date
undefined (undefined)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
European Organisation for Research and Treatment of Cancer - EORTC

4. Oversight

5. Study Description

Brief Summary
RATIONALE: Drugs used in chemotherapy use different ways to stop cancer cells from dividing so they stop growing or die. Combining more than one drug may kill more tumor cells. PURPOSE: Phase II trial to study the effectiveness of combination chemotherapy in treating older patients who have non-Hodgkin's lymphoma.
Detailed Description
OBJECTIVES: Determine the complete remission (CR) rate and duration of CR in frail elderly patients with diffuse large B-cell or peripheral T-cell non-Hodgkin's lymphoma treated with cyclophosphamide, vincristine, and prednisone. Determine the time to progression and overall survival of patients treated with this regimen. Determine the severe toxicity rate of this regimen in these patients. Assess the quality of life of patients treated with this regimen. OUTLINE: This is a multicenter study. Patients receive cyclophosphamide IV and vincristine IV on day 1 and oral prednisone on days 1-5. Treatment repeats every 3 weeks for 3 courses in the absence of disease progression or unacceptable toxicity. Patients with stage I or II non-Hodgkin's lymphoma (NHL), no baseline lactate dehydrogenase (LDH) elevation, baseline WHO performance status 0-1, and longest tumor diameter of less than 5 cm, who achieve partial response (PR) or complete response (CR), receive 1 additional course of chemotherapy. Patients then undergo involved-field radiotherapy once daily 5 days a week for 3.5-4 weeks. Patients with stage I or II NHL, a baseline LDH elevation, and/or baseline WHO performance status 2-4, and/or longest tumor diameter of at least 5 cm, who achieve PR or CR, receive 3 additional courses of chemotherapy. Patients then undergo involved-field radiotherapy once daily 5 days a week for 3.5-4 weeks. Patients with stage III or IV NHL who achieve CR or PR receive 3 additional courses of chemotherapy. Patients then undergo consolidative radiotherapy once daily 5 days a week for 2.5-3 weeks. Quality of life is assessed at baseline, after the third chemotherapy course, at the end of chemotherapy, every 6 months for 3 years, and then annually thereafter. Patients are followed every 3 months for 3 years, every 6 months for 2 years, and then annually thereafter. PROJECTED ACCRUAL: A total of 29-56 patients will be accrued for this study within 12-18 months.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Lymphoma
Keywords
stage I adult diffuse large cell lymphoma, stage III adult diffuse large cell lymphoma, stage IV adult diffuse large cell lymphoma, contiguous stage II adult diffuse large cell lymphoma, noncontiguous stage II adult diffuse large cell lymphoma, angioimmunoblastic T-cell lymphoma

7. Study Design

Primary Purpose
Treatment
Study Phase
Phase 2
Masking
None (Open Label)
Enrollment
32 (Actual)

8. Arms, Groups, and Interventions

Intervention Type
Drug
Intervention Name(s)
cyclophosphamide
Intervention Type
Drug
Intervention Name(s)
prednisone
Intervention Type
Drug
Intervention Name(s)
vincristine sulfate
Intervention Type
Radiation
Intervention Name(s)
radiation therapy

10. Eligibility

Sex
All
Minimum Age & Unit of Time
70 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
DISEASE CHARACTERISTICS: Diagnosis of diffuse large B-cell or peripheral T-cell non-Hodgkin's lymphoma (NHL) No Burkitt's-like lymphoma Small cells in bone marrow allowed Previously untreated NHL At least 1 measurable lesion At least 1.1 cm Poor physiological status with at least 1 of the following: WHO performance status of 3-4 LVEF less than 50% Creatinine clearance less than 50 mL/min Neutrophil count no greater than 1,500/mm^3 Platelet count no greater than 100,000/mm^3 Concurrent severe disease that would preclude cyclophosphamide, vincristine, prednisolone, and doxorubicin No cerebral or meningeal involvement PATIENT CHARACTERISTICS: Age: 70 and over Performance status: See Disease Characteristics Life expectancy: Not specified Hematopoietic: See Disease Characteristics Hepatic: Not specified Renal: See Disease Characteristics Other: HIV negative No other malignancy within the past 5 years except adequately treated basal cell skin cancer, curatively treated carcinoma in situ of the cervix, or curatively treated solid tumor No active infection No psychological, familial, sociological, or geographical condition that would preclude study participation PRIOR CONCURRENT THERAPY: Biologic therapy: Not specified Chemotherapy: See Disease Characteristics Endocrine therapy: Not specified Radiotherapy: Not specified Surgery: Not specified Other: No other concurrent investigational drugs No other concurrent antineoplastic agents
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Pierre Soubeyran, MD, PhD
Organizational Affiliation
Institut Bergonié
Official's Role
Study Chair
Facility Information:
Facility Name
Ziekenhuis Network Antwerpen Middelheim
City
Antwerp
ZIP/Postal Code
2020
Country
Belgium
Facility Name
Centre Hospitalier Universitaire Brugmann
City
Brussels
ZIP/Postal Code
B 1020
Country
Belgium
Facility Name
U.Z. Gasthuisberg
City
Leuven
ZIP/Postal Code
B-3000
Country
Belgium
Facility Name
National Cancer Institute of Egypt
City
Cairo
Country
Egypt
Facility Name
Centre D'Oncologie Du Pays-Basque
City
Bayonne
ZIP/Postal Code
F-64100
Country
France
Facility Name
Hopital Saint Andre
City
Bordeaux
ZIP/Postal Code
33075
Country
France
Facility Name
Institut Bergonie
City
Bordeaux
ZIP/Postal Code
33076
Country
France
Facility Name
Centre Hospitalier de Dax
City
Dax
ZIP/Postal Code
40107
Country
France
Facility Name
Hopital Robert Boulin
City
Libourne
ZIP/Postal Code
33500
Country
France
Facility Name
Polyclinique de Francheville
City
Perigueux
ZIP/Postal Code
24004
Country
France
Facility Name
Onze Lieve Vrouwe Gasthuis
City
Amsterdam
ZIP/Postal Code
1091 HA
Country
Netherlands
Facility Name
Academisch Ziekenhuis Groningen
City
Groningen
ZIP/Postal Code
9700 RB
Country
Netherlands
Facility Name
University Medical Center Nijmegen
City
Nijmegen
ZIP/Postal Code
NL-6500 HB
Country
Netherlands
Facility Name
Hospitais da Universidade de Coimbra (HUC)
City
Coimbra
ZIP/Postal Code
3001-301
Country
Portugal
Facility Name
Hopitaux Universitaires de Geneve
City
Thonex-Geneve
ZIP/Postal Code
CH-1226
Country
Switzerland
Facility Name
New Cross Hospital
City
Wolverhampton
State/Province
England
ZIP/Postal Code
WV10 0QP
Country
United Kingdom
Facility Name
Dumfries Royal Infirmary
City
Dumfries
ZIP/Postal Code
DG1 4AP
Country
United Kingdom

12. IPD Sharing Statement

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Combination Chemotherapy in Treating Older Patients With Non-Hodgkin's Lymphoma

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