Skip to main content
OpenTrials
Completed

NCT Number: NCT00039351

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

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.

Completed

Looking for future studies?

Notify Me

Key information

Age range

70 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 2

Primary location

Ziekenhuis Network Antwerpen Middelheim, Antwerp, Belgium

Loading trial locations.

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Cyclophosphamide

Drug

Prednisone

Drug

vincristine sulfate

Drug

radiation therapy

Radiation

Sponsors and collaborators

Lead sponsor

European Organisation for Research and Treatment of Cancer - EORTC

Network

Registry information

Official study 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

Important dates

Study start
2002
Primary completion
2005
First posted
Jan 27, 2003
Registry last updated
Sep 24, 2012

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

Published trials that share one or more normalized conditions with this study.