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.
調査の概要
詳細な説明
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.
研究の種類
入学 (実際)
段階
- フェーズ2
連絡先と場所
研究場所
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Dumfries、イギリス、DG1 4AP
- Dumfries Royal Infirmary
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England
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Wolverhampton、England、イギリス、WV10 0QP
- New Cross Hospital
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Cairo、エジプト
- National Cancer Institute of Egypt
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Amsterdam、オランダ、1091 HA
- Onze Lieve Vrouwe Gasthuis
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Groningen、オランダ、9700 RB
- Academisch Ziekenhuis Groningen
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Nijmegen、オランダ、NL-6500 HB
- University Medical Center Nijmegen
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Thonex-Geneve、スイス、CH-1226
- Hopitaux Universitaires de Geneve
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Bayonne、フランス、F-64100
- Centre d'Oncologie du Pays-Basque
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Bordeaux、フランス、33076
- Institut Bergonie
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Bordeaux、フランス、33075
- Hopital Saint André
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Dax、フランス、40107
- Centre Hospitalier de Dax
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Libourne、フランス、33500
- Hôpital Robert Boulin
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Perigueux、フランス、24004
- Polyclinique de Francheville
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Antwerp、ベルギー、2020
- Ziekenhuis Network Antwerpen Middelheim
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Brussels、ベルギー、B 1020
- Centre Hospitalier Universitaire Brugmann
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Leuven、ベルギー、B-3000
- U.Z. Gasthuisberg
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Coimbra、ポルトガル、3001-301
- Hospitais da Universidade de Coimbra (HUC)
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参加基準
適格基準
就学可能な年齢
健康ボランティアの受け入れ
受講資格のある性別
説明
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
研究計画
研究はどのように設計されていますか？
デザインの詳細
- 主な目的：処理
- マスキング：なし（オープンラベル）
協力者と研究者
研究記録日
主要日程の研究
研究開始
一次修了 (実際)
試験登録日
最初に提出
QC基準を満たした最初の提出物
最初の投稿 (見積もり)
学習記録の更新
投稿された最後の更新 (見積もり)
QC基準を満たした最後の更新が送信されました
最終確認日
詳しくは
本研究に関する用語
キーワード
追加の関連 MeSH 用語
その他の研究ID番号
- EORTC-20992
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