NCT00008047Unknown1 期
Multicentre Phase II Study Of Concomitant Radio-Chemotherapy Associating Continuous Infusion 5-FU With Hydroxyuree Via Bone Marrow With Or Without Paclitaxel In Treatment Of Inoperable Epidermoid Carcinoma Of Esophagus
GERCOR - Multidisciplinary Oncology Cooperative Group28 个研究点 分布在 1 个国家开始时间: 1999年8月1日最近更新:
适应症
相关药物
试验速览
- 阶段
- 1 期
- 发起方
- 试验地点
- 28
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. Combining more than one chemotherapy drug with radiation therapy may kill more tumor cells.
PURPOSE: Randomized phase I/II trial to study the effectiveness of combination chemotherapy with or without paclitaxel combined with radiation therapy in treating patients who have stage II or stage III cancer of the esophagus.
详细描述
OBJECTIVES:
- Compare the efficacy of concurrent radiotherapy with fluorouracil and hydroxyurea with or without paclitaxel in terms of survival without dysphagia in patients with inoperable stage II or III epidermoid carcinoma of the esophagus.
- Compare the overall survival, response rate, toxicity, and quality of life in this patient population treated with these regimens.
OUTLINE: This is a randomized, open label, multicenter study. Patients are stratified according to weight loss (less than 10% vs at least 10%) and inoperability criteria (nonresectable vs due to anatomical terrain). Patients are randomized to one of two treatment arms.
- Arm I: Patients receive fluorouracil IV continuously, oral hydroxyurea, and concurrent radiotherapy daily on days 1-5.
- Arm II: Patients receive fluorouracil, hydroxyurea and radiotherapy as in arm I. Patients also receive paclitaxel IV on day 1.
Treatment continues every 2 weeks for 4 courses in the absence of disease progression or unacceptable toxicity.
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 80 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •DISEASE CHARACTERISTICS:
- •Histologically confirmed stage II (T2 or T3, N0, M0) or III (T3, N1, M0) epidermoid carcinoma of the esophagus
- •Inoperable due to initial extension or inoperable with no extension
- •No visceral metastases
- •No extension to the tracheo-bronchial pathway
- •No tracheo-esophageal fistula
- •No broncho-esophageal fistula
- •No suspected respiratory mucosal involvement on bronchoscopy
- •No carcinoma in situ
- •PATIENT CHARACTERISTICS:
- •Performance status:
- •Life expectancy:
- •Not specified
- •Hematopoietic:
- •Platelet count at least 120,000/mm^3
- •Hemoglobin at least 10 g/dL
- •Neutrophil count at least 1,500/mm^3
- •Lymphocyte count at least 1,000/mm^3
- •SGOT and SGPT no greater than 2 times normal
- •Albumin at least 3.0 g/dL
- •Creatinine no greater than 1.4 mg/dL
- •Calcium less than 11.2 mg/dL
- •See Disease Characteristics
- •No severe respiratory illness (e.g., severe broncho-pathway obstruction or insufficient respiration)
- •No uncontrolled broncho-pulmonary infection
- •No other prior history of malignancy except curatively treated carcinoma in situ of the colon or skin cancer
- •No contraindication to fluorouracil
- •Not pregnant or nursing
- •Fertile patients must use effective contraception
- •No psychiatric illness
- •HIV negative
- •Total protein at least 65% of normal
- •PRIOR CONCURRENT THERAPY:
- •Biologic therapy:
- •No prior biologic therapy
- •Chemotherapy:
- •No prior chemotherapy
- •Endocrine therapy:
- •No prior endocrine therapy
- •Radiotherapy:
- •No prior radiotherapy
- •See Disease Characteristics
- •No concurrent participation in other study
排除标准
- 未提供
研究者
研究点 (28)
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