A Phase III Randomized, Open-Label Comparative Study of Induction Chemotherapy Followed by Thoracic Radiation Therapy With Supplemental Oxygen, With or Without Concurrent RSR13 (Efaproxiral), in Patients With Locally Advanced Unresectable (Stage IIIA/IIIB) Non-Small Cell Lung Cancer
试验速览
- 阶段
- 3 期
- 状态
- 撤回
- 试验地点
- 44
研究概览
简要总结
RATIONALE: Drugs used in chemotherapy use different ways to stop tumor cells from dividing so they stop growing or die. Radiation therapy uses high-energy x-rays to damage tumor cells. Drugs such as efaproxiral may make the tumor cells more sensitive to radiation therapy. It is not yet known if chemotherapy combined with radiation therapy is more effective with or without efaproxiral in treating non-small cell lung cancer.
PURPOSE: Randomized phase III trial to compare the effectiveness of chemotherapy combined with radiation therapy with or without efaproxiral in treating patients who have stage III non-small cell lung cancer.
详细描述
OBJECTIVES:
- Compare the overall survival of patients with stage IIIA or IIIB non-small cell lung cancer treated with induction chemotherapy followed by radiotherapy with or without efaproxiral.
- Compare time to progression, response rate, and pattern of failure of patients treated with these regimens.
- Determine the safety of efaproxiral in these patients.
- Determine the pharmacokinetics of efaproxiral in these patients.
- Compare quality of life of patients treated with these regimens.
OUTLINE: This is a randomized, open-label, multicenter study. Patients are stratified according to chemotherapy regimen, Karnofsky performance status (70-80% vs 90-100%), and disease stage (IIIA vs IIIB).
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Induction therapy phase: Patients receive 1 of the following induction chemotherapy regimens:
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Paclitaxel and carboplatin: Patients receive paclitaxel IV and carboplatin IV on day 1. Treatment repeats every 21 days for a total of 2 courses.
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Cisplatin and gemcitabine: Patients receive cisplatin IV on day 2 and gemcitabine IV on days 1, 8, and 15. Treatment repeats every 28 days for a total of 2 courses.
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Cisplatin and vinorelbine: Patients receive cisplatin IV on day 1 and vinorelbine IV on days 1, 8, and either 15 or 22. Treatment repeats every 28 days for a total of 2 courses.
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Randomized phase: Within 42 days after completion of chemotherapy, patients are randomized to 1 of 2 treatment arms.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 主要目的
- Treatment
- 盲法
- None
入排标准
- 年龄范围
- 18 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •DISEASE CHARACTERISTICS:
- •Histologically or cytologically confirmed locally advanced, unresectable non-small cell lung cancer of 1 of the following subtypes:
- •Adenocarcinoma
- •Squamous cell carcinoma
- •Large cell carcinoma
- •Poorly differentiated carcinoma
- •Stage IIIA or IIIB
- •T1 or T2, N2
- •T3, N1 or N2
- •T4, any N
- •Any T, N3
- •Histological or cytological confirmation of at least 1 positive lymph node required if the largest mediastinal node that is the basis of stage III disease is less than 2.0 cm in diameter
- •Clinically or radiologically measurable disease of at least 2.0 cm
- •Partially resected stage IIIB disease allowed provided a measurable lesion remains
- •No pleural effusion that is bloody, cytologically positive, or re-accumulated after thoracentesis
- •No metastatic disease by CT scan or MRI
- •PATIENT CHARACTERISTICS:
- •18 and over
- •Performance status
- •Karnofsky 70-100%
- •Life expectancy
- •Not specified
- •Hematopoietic
- •Hemoglobin at least 10 g/dL
- •WBC at least 3,000/mm^3
- •Absolute granulocyte count at least 2,000/mm^3
- •Platelet count at least 100,000/mm^3
- •Bilirubin no greater than 1.5 times upper limit of normal (ULN)
- •AST and ALT no greater than 2.5 times ULN
- •Creatinine no greater than 1.5 mg/dL
- •Cardiovascular
- •No clinically active congestive heart failure
- •No unstable angina
- •No severe arrhythmia by ECG
- •FVC and FEV_1 at least 50% of normal
- •Resting oxygen saturation by pulse oximetry (SpO_2) at least 90% on room air
- •Exercise SpO_2 at least 90% on room air
- •Not pregnant or nursing
- •Negative pregnancy test
- •Fertile female patients must use effective contraception during and for 30 days after study therapy
- •Male patients must use effective contraception during and for 90 days after study therapy
- •No loss of more than 10% of body weight within the past 3 months
- •No other malignancy within the past 5 years except nonmelanoma skin cancer or carcinoma in situ of the cervix
- •No significantly altered mental status or dementia that would preclude giving informed consent
- •No active infection
- •No other serious underlying medical condition that would preclude study participation
- •PRIOR CONCURRENT THERAPY:
- •Biologic therapy
- •More than 28 days since prior biologic therapy
- •No concurrent colony-stimulating factors (randomized phase only)
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排除标准
- 未提供