Non-Operative Therapy Of Local-Regional Carcinoma Of The Esophagus: A Randomizd Phase II Study Of Two Paclitaxel-Based Chemoradiotherapy Regimens
试验速览
- 阶段
- 2 期
- 状态
- 已完成
- 试验地点
- 132
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 chemotherapy and radiation therapy may kill more tumor cells.
PURPOSE: Randomized phase II trial to compare the effectiveness of combination chemotherapy plus radiation therapy with and without fluorouracil in treating patients who have cancer of the esophagus or stomach.
详细描述
OBJECTIVES:
- Compare the survival and failure patterns in patients with previously untreated carcinoma of the esophagus or gastroesophageal junction treated with cisplatin, paclitaxel, and concurrent radiotherapy with or without fluorouracil.
- Compare the tolerance of these regimens by these patients.
- Compare the overall quality of life of patients treated with these regimens.
OUTLINE: This is a randomized, multicenter study. Patients are stratified according to percentage of weight loss (less than 10% vs 10% or more), disease histology (adenocarcinoma vs squamous cell carcinoma), and lesion size (no more than 5 cm vs more than 5 cm). Patients are randomized to one of two treatment arms.
- Arm I: Patients receive induction chemotherapy comprising fluorouracil IV continuously over 24 hours and cisplatin IV over 1 hour on days 1-5, paclitaxel IV continuously over 24 hours on day 1, and filgrastim (G-CSF) subcutaneously daily on days 6-15. Treatment repeats every 4 weeks for up to 2 courses. Patients with stable or responsive disease after the first course of induction therapy receive a second course of therapy. Patients with local disease progression after the first course proceed to chemoradiotherapy.
Beginning on day 29 of the last course of induction chemotherapy, patients undergo radiotherapy 5 days a week for 5.5 weeks. Patients also receive fluorouracil IV continuously over 24 hours on days 1-5, 8-12, 15-19, 22-26, and 29-33, and paclitaxel IV over 3 hours on days 1, 8, 15, 22, and 29.
研究设计
- 研究类型
- Interventional
- 主要目的
- Treatment
入排标准
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •DISEASE CHARACTERISTICS:
- •Histologically confirmed primary squamous cell carcinoma or adenocarcinoma of the esophagus or gastroesophageal junction
- •Stage I-III (T1, N1, M0; T2-4, N any, M0)
- •Supraclavicular or celiac lymph node involvement allowed
- •Disease entirely confined to the esophagus or gastroesophageal junction and peri-esophageal soft tissue
- •Cervical esophageal carcinoma allowed
- •No tumor extension beyond 2 cm into stomach
- •No multiple primary carcinomas of the esophagus
- •No evidence of disseminated cancer
- •No tracheoesophageal fistula or direct invasion into the mucosa of the trachea or major bronchi
- •Bronchoscopy with biopsy and cytology required if the primary carcinoma is less than 26 cm from the incisors or is at or above the carina by imaging study
- •PATIENT CHARACTERISTICS:
- •Not specified
- •Performance status:
- •Zubrod 0-1
- •Life expectancy:
- •Not specified
- •Hematopoietic:
- •Absolute neutrophil count at least 1,500/mm^3
- •Platelet count at least 150,000/mm^3
- •Hemoglobin at least 10 g/dL
- •Not specified
- •Creatinine no greater than 1.5 mg/dL
- •Creatinine clearance at least 65 mL/min
- •Cardiovascular:
- •No uncontrolled heart disease
- •No uncontrolled hypertension
- •Total oral/enteral intake must be at least 1,700 kCal/day
- •Not pregnant or nursing
- •Fertile patients must use effective contraception
- •No uncontrolled diabetes
- •No other malignancy within the past 5 years except curatively treated nonmelanoma skin cancer or carcinoma in situ of the cervix
- •PRIOR CONCURRENT THERAPY:
- •Biologic therapy:
- •Not specified
- •Chemotherapy:
- •No prior systemic chemotherapy
- •No other concurrent chemotherapy
- •Endocrine therapy:
- •Not specified
- •Radiotherapy:
- •No prior chest radiotherapy
- •No prior major esophageal surgery
排除标准
- 未提供