Combination Chemotherapy in Treating Older Patients With Non-Hodgkin's Lymphoma
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
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.
연구 개요
상세 설명
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.
연구 유형
등록 (실제)
단계
- 2 단계
연락처 및 위치
연구 장소
-
-
-
Amsterdam, 네덜란드, 1091 HA
- Onze Lieve Vrouwe Gasthuis
-
Groningen, 네덜란드, 9700 RB
- Academisch Ziekenhuis Groningen
-
Nijmegen, 네덜란드, NL-6500 HB
- University Medical Center Nijmegen
-
-
-
-
-
Antwerp, 벨기에, 2020
- Ziekenhuis Network Antwerpen Middelheim
-
Brussels, 벨기에, B 1020
- Centre Hospitalier Universitaire Brugmann
-
Leuven, 벨기에, B-3000
- U.Z. Gasthuisberg
-
-
-
-
-
Thonex-Geneve, 스위스, CH-1226
- Hopitaux Universitaires de Geneve
-
-
-
-
-
Dumfries, 영국, DG1 4AP
- Dumfries Royal Infirmary
-
-
England
-
Wolverhampton, England, 영국, WV10 0QP
- New Cross Hospital
-
-
-
-
-
Cairo, 이집트
- National Cancer Institute of Egypt
-
-
-
-
-
Coimbra, 포르투갈, 3001-301
- Hospitais da Universidade de Coimbra (HUC)
-
-
-
-
-
Bayonne, 프랑스, F-64100
- Centre d'Oncologie du Pays-Basque
-
Bordeaux, 프랑스, 33076
- Institut Bergonie
-
Bordeaux, 프랑스, 33075
- Hopital Saint André
-
Dax, 프랑스, 40107
- Centre Hospitalier de Dax
-
Libourne, 프랑스, 33500
- Hôpital Robert Boulin
-
Perigueux, 프랑스, 24004
- Polyclinique de Francheville
-
-
참여기준
자격 기준
공부할 수 있는 나이
건강한 자원 봉사자를 받아들입니다
연구 대상 성별
설명
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
공부 계획
연구는 어떻게 설계됩니까?
디자인 세부사항
- 주 목적: 치료
- 마스킹: 없음(오픈 라벨)
공동 작업자 및 조사자
연구 기록 날짜
연구 주요 날짜
연구 시작
기본 완료 (실제)
연구 등록 날짜
최초 제출
QC 기준을 충족하는 최초 제출
처음 게시됨 (추정)
연구 기록 업데이트
마지막 업데이트 게시됨 (추정)
QC 기준을 충족하는 마지막 업데이트 제출
마지막으로 확인됨
추가 정보
이 연구와 관련된 용어
키워드
추가 관련 MeSH 약관
기타 연구 ID 번호
- EORTC-20992
이 정보는 변경 없이 clinicaltrials.gov 웹사이트에서 직접 가져온 것입니다. 귀하의 연구 세부 정보를 변경, 제거 또는 업데이트하도록 요청하는 경우 register@clinicaltrials.gov. 문의하십시오. 변경 사항이 clinicaltrials.gov에 구현되는 즉시 저희 웹사이트에도 자동으로 업데이트됩니다. .