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Combination Chemotherapy in Treating Patients With Advanced Non-small Cell Lung Cancer

2012年3月5日更新者：European Organisation for Research and Treatment of Cancer - EORTC

Randomized Study With New Combination Chemotherapies in Advanced Non-Small Cell Lung Cancer

RATIONALE: Drugs used in chemotherapy use different ways to stop tumor cells from dividing so they stop growing or die. Combining more than one drug may kill more tumor cells. It is not yet known which combination chemotherapy regimen is more effective in treating advanced non-small cell lung cancer.

PURPOSE: Randomized phase III trial to compare the effectiveness of three different combination chemotherapy regimens in treating patients who have advanced non-small cell lung cancer.

研究概览

地位

完全的

条件

肺癌

干预/治疗

详细说明

OBJECTIVES: I. Compare the overall survival between paclitaxel/cisplatin (arm I), gemcitabine/cisplatin (arm II), and paclitaxel/gemcitabine (arm III) in patients with advanced non-small cell lung cancer. II. Determine the response rate, duration of response, progression-free survival, toxicity, and quality of life of these patients randomized in these three treatment arms.

OUTLINE: This is randomized, multicenter study. Patients are stratified according to performance status (0-1 vs 2) and stage of disease (locally advanced vs metastatic). Patients are randomized to receive paclitaxel IV over 3 hours on day 1 followed by cisplatin IV on day 1 every 3 weeks (arm I), gemcitabine IV over 30-60 minutes on days 1 and 8 and cisplatin IV on day 1 every 3 weeks (arm II), or paclitaxel IV over 3 hours on day 1 followed by gemcitabine IV over 30-60 minutes on days 1 and 8 every 3 weeks (arm III). Patients receive at least 2 courses of treatment. In the absence of unacceptable toxicity and disease progression, patients may receive up to 6 courses of treatment. Quality of life is assessed before, during, and at the end of treatment, then every 6 weeks until disease progression, and then every 3 months until death. Patients are followed every 6 weeks until disease progression, then every 3 months until death.

PROJECTED ACCRUAL: A total of 450 patients (150 patients per arm) will be accrued into this study over 36 months.

研究类型

介入性

注册 (预期的)

450

阶段

第三阶段

联系人和位置

本节提供了进行研究的人员的详细联系信息，以及有关进行该研究的地点的信息。

学习地点

南非
- - Johannesburg、南非、2193
    - Medical Oncology Centre of Rosebank
埃及
- - Cairo、埃及
    - National Cancer Institute of Egypt
希腊
- - Athens、希腊、GR-11527
    - Hippokration General Hospital of Athens
德国
- - Heidelberg、德国、D-69126
    - Thoraxklinik Rohrbach
意大利
- - Biella、意大利、13900
    - Ospedale Degli Infermi
捷克共和国
- - Krhanice、捷克共和国、257 42
    - University Hospital Bulovka
比利时
- - Antwerp、比利时、2020
    - Algemeen Ziekenhuis Middelheim
法国
- - Vandoeuvre-Les-Nancy、法国、54511
    - CHRU de Nancy - Hôpitaux de Brabois
波兰
- - Gdynia、波兰、PL-81--519
    - Maritime Hospital
瑞士
- - Bellinzona、瑞士、CH-6500
    - Ospedale San Giovanni
荷兰
- - 's-Gravenhage (Den Haag, The Hague)、荷兰、2545 CH
    - Leyenburg Ziekenhuis
  - 's-Hertogenbosch、荷兰、5211 NL
    - Groot Ziekengasthuis 's-Hertogenbosch
  - Amsterdam、荷兰、1105 AZ
    - Academisch Medisch Centrum
  - Amsterdam、荷兰、1091 HA
    - Onze Lieve Vrouwe Gasthuis
  - Amsterdam、荷兰、1117 MB
    - Academisch Ziekenhuis der Vrije Universiteit
  - Apeldoorn、荷兰、7334 DZ
    - Gelre Ziekenhuizen - Lokatie Lukas
  - Arnhem、荷兰、6815 AD
    - Arnhems Radiotherapeutisch Instituut
  - Breda、荷兰、4810 EV
    - Ziekenhuis de Baronie
  - Eindhoven、荷兰、5602 ZA
    - Catharina Ziekenhuis
  - Harderwijk、荷兰、3840 AC
    - Ziekenhuis St Jansdal
  - Helmond、荷兰、5707-HA
    - Elkerliek Ziekenhuis
  - Leiden、荷兰、2300 ZA
    - Leiden University Medical Center
  - Leiderdorp、荷兰、2350 CC
    - Rijnland Ziekenhuis
  - Maastricht、荷兰、6202 AZ
    - Academisch Ziekenhuis Maastricht
  - Nieuwegein、荷兰、3435 CM
    - Sint Antonius Ziekenhuis
  - Nijmegen、荷兰、NL-6252 HB
    - University Medical Center Nijmegen
  - Rotterdam、荷兰、3000 CA
    - University Hospital - Rotterdam Dijkzigt
  - Utrecht、荷兰、3508 GA
    - Academisch Ziekenhuis Utrecht
  - Venlo、荷兰、5900 BX
    - St. Maartens Gasthuis
  - Zaandam、荷兰、1502 DV
    - Ziekenhuis de Heel
  - Zwolle、荷兰、8000 GK
    - Sophia Ziekehuis
西班牙
- - Madrid、西班牙、28041
    - Hospital Universitario 12 de Octubre
  - Madrid、西班牙
    - Hospital Universitario de Getafe

参与标准

研究人员寻找符合特定描述的人，称为资格标准。这些标准的一些例子是一个人的一般健康状况或先前的治疗。

资格标准

适合学习的年龄

18年至 75年 (成人、年长者)

接受健康志愿者

不

有资格学习的性别

全部

描述

DISEASE CHARACTERISTICS: Histologically confirmed advanced non-small cell lung cancer that is progressive within 2 months prior to study entry Stage IIIB due to malignant pleural effusion or supraclavicular lymph node involvement only Stage IV At least 1 bidimensionally or unidimensionally measurable target lesion Brain metastases or leptomeningeal disease that have been treated with radiotherapy, is stable without medications (e.g., steroids), and asymptomatic are allowed

PATIENT CHARACTERISTICS: Age: 18 to 75 Performance status: WHO 0-2 Life expectancy: Not specified Hematopoietic: Absolute neutrophil count at least 2,000/mm3 Platelet count at least 100,000/mm3 Prothrombin time less than 1.5 times normal Hepatic: Bilirubin no greater than 1.25 times upper limit of normal (ULN) (no greater than 2.5 times ULN if due to liver metastases) AST or ALT less than 3 times ULN (no greater than 5 times ULN if due to liver metastases) Renal: Creatinine clearance at least 60 mL/min Cardiovascular: No uncontrolled cardiac disease, sign of cardiac failure, or rhythm disturbances requiring medication No myocardial infarction in the past 3 months Neurological: No preexisting motor or sensory neurotoxicity of grade 2 or greater Other: No active uncontrolled infection Not a poor medical risk due to nonmalignant disease No secondary primary malignancy in the past 5 years (excluding melanoma, breast cancer, and hypernephroma) except carcinoma in situ of the cervix or adequately treated basal cell carcinoma of the skin No psychological condition that might hamper compliance in this study Not pregnant Effective contraception required of all fertile patients during and for 3 months after study

PRIOR CONCURRENT THERAPY: Biologic therapy: At least 4 weeks since prior immunotherapy No concurrent colony stimulating factor except for secondary prophylaxis in case of infection and severe neutropenia No concurrent immunotherapy Chemotherapy: No prior chemotherapy for advanced disease, including intracavitary chemotherapy At least 1 year since prior neoadjuvant or adjuvant chemotherapy No concurrent chemotherapy Endocrine therapy: See Disease Characteristics No concurrent hormonal agents (except corticosteroids for antiemetic prophylaxis) Radiotherapy: Prior radiotherapy should not include all target lesions for evaluation At least 4 weeks since prior radiotherapy Concurrent palliative radiotherapy allowed if indicator lesion is outside of radiation field Surgery: Not specified

学习计划

本节提供研究计划的详细信息，包括研究的设计方式和研究的衡量标准。

研究是如何设计的？

设计细节

主要用途：治疗
分配：随机化

合作者和调查者

在这里您可以找到参与这项研究的人员和组织。

赞助

European Organisation for Research and Treatment of Cancer - EORTC

调查人员

学习椅：Egbert F. Smit, MD、Free University Medical Center

出版物和有用的链接

负责输入研究信息的人员自愿提供这些出版物。这些可能与研究有关。

一般刊物

研究记录日期

这些日期跟踪向 ClinicalTrials.gov 提交研究记录和摘要结果的进度。研究记录和报告的结果由国家医学图书馆 (NLM) 审查，以确保它们在发布到公共网站之前符合特定的质量控制标准。

研究主要日期

学习开始

1998年8月1日

初级完成 (实际的)

2000年7月1日

研究注册日期

首次提交

1999年11月1日

首先提交符合 QC 标准的

2004年7月12日

首次发布 (估计)

2004年7月13日

研究记录更新

最后更新发布 (估计)

2012年3月6日

上次提交的符合 QC 标准的更新

2012年3月5日

最后验证

2012年3月1日