A Phase I/II Escalation Study of Thoracic Irradiation With Concurrent Chemotherapy for Patients With Limited Small Cell Lung Cancer
试验速览
- 阶段
- 1 期
- 状态
- 已完成
- 入组人数
- 64
- 试验地点
- 262
- 主要终点
- Frequency of patients developing unacceptable (grade 3 or higher) acute toxicities attributable to thoracic irradiation with concurrent chemotherapy
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: Phase I trial to study the effectiveness of radiation therapy plus combination chemotherapy in treating patients with limited-stage small cell lung cancer.
详细描述
OBJECTIVES: I. Determine the maximum tolerated dose of thoracic radiation using an accelerated boost with concurrent chemotherapy in patients with small cell lung cancer. II. Evaluate the response rate and overall survival in these patients. III. Reduce the toxic effects of treatment to esophagus and lungs.
OUTLINE: This is a radiation dose escalation study. Patients are sequentially accrued to one of four radiation dose levels. Dose level 1: Patients receive radiotherapy 5 days a week for 4 weeks followed by radiation boost given daily for 2 days, then twice daily for 3 days during week 5. (Closed to accrual 6/98) Dose level 2: Patients receive radiotherapy 5 days a week for 4 weeks followed by radiation boost given twice daily for 5 days during week 5. (Closed to accrual 9/24/99) Dose level 3: Patients receive radiotherapy 5 days a week for 18 days followed by radiation boost given in the evenings on days 19 and 20, then twice daily for 5 days during week 5. (Closed to accrual 5/5/00) Dose level 4: Patients receive radiotherapy 5 days a week for 16 days followed by radiation boost given in the evenings on days 17-20, then twice daily for 5 days during week 5. The fifth dose level is the same as the first dose level. (Closed to accrual 3/19/99) Cohorts of 5 patients are entered at each radiation dose level. If one patient experiences nonhematologic dose limiting toxicity (DLT), 5 additional patients are treated at that level. If no further DLT occurs, escalation to the next arm proceeds. Patients receive cisplatin IV plus etoposide IV on day 1 of radiotherapy and oral etoposide on days 2 and 3 every 3 weeks for 4 courses. Patients are followed every 3 months for 1 year, every 6 months for 2 years and then annually thereafter.
PROJECTED ACCRUAL: A total of 20-40 patients will be accrued for this study within 5-10 months.
研究设计
- 研究类型
- Interventional
- 分配方式
- Non Randomized
- 干预模型
- Single Group
- 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
- 未提供
排除标准
- 未提供
研究组 & 干预措施
Arm 3
Large field radiation therapy 32.4 Gy, 1.8 Gy/fx/D/5 days x 18 fx, boost just in pm @ 1.8 Gy/fx on days 19 & 20, then boost 1.8 Gy BID x last 5 days.
干预措施: etoposide (Drug)
Arm 1
Large field radiation therapy 36 Gy, 1.8 Gy/fx/D/5 days/4 weeks, boost 1.8 Gy/D x 2 days, then BID x last 3 days.
干预措施: cisplatin (Drug)
Arm 1
Large field radiation therapy 36 Gy, 1.8 Gy/fx/D/5 days/4 weeks, boost 1.8 Gy/D x 2 days, then BID x last 3 days.
干预措施: etoposide (Drug)
Arm 1
Large field radiation therapy 36 Gy, 1.8 Gy/fx/D/5 days/4 weeks, boost 1.8 Gy/D x 2 days, then BID x last 3 days.
干预措施: radiation therapy (Radiation)
Arm 2
Large field radiation therapy 36 Gy, 1.8 Gy/fx/D/5 days/4 weeks, boost 1.8 Gy/BID x last 5 days.
干预措施: cisplatin (Drug)
Arm 2
Large field radiation therapy 36 Gy, 1.8 Gy/fx/D/5 days/4 weeks, boost 1.8 Gy/BID x last 5 days.
干预措施: etoposide (Drug)
Arm 2
Large field radiation therapy 36 Gy, 1.8 Gy/fx/D/5 days/4 weeks, boost 1.8 Gy/BID x last 5 days.
干预措施: radiation therapy (Radiation)
Arm 3
Large field radiation therapy 32.4 Gy, 1.8 Gy/fx/D/5 days x 18 fx, boost just in pm @ 1.8 Gy/fx on days 19 & 20, then boost 1.8 Gy BID x last 5 days.
干预措施: cisplatin (Drug)
Arm 3
Large field radiation therapy 32.4 Gy, 1.8 Gy/fx/D/5 days x 18 fx, boost just in pm @ 1.8 Gy/fx on days 19 & 20, then boost 1.8 Gy BID x last 5 days.
干预措施: radiation therapy (Radiation)
Arm 4
Large field radiation therapy 28.8 Gy, 1.8 Gy/fx/5 days x 16 fx, boost just in pm @ 1.8 Gy/fx on days 17-20, then boost 1.8 Gy BID x last 5 days.
干预措施: cisplatin (Drug)
Arm 4
Large field radiation therapy 28.8 Gy, 1.8 Gy/fx/5 days x 16 fx, boost just in pm @ 1.8 Gy/fx on days 17-20, then boost 1.8 Gy BID x last 5 days.
干预措施: etoposide (Drug)
Arm 4
Large field radiation therapy 28.8 Gy, 1.8 Gy/fx/5 days x 16 fx, boost just in pm @ 1.8 Gy/fx on days 17-20, then boost 1.8 Gy BID x last 5 days.
干预措施: radiation therapy (Radiation)
Arm 5
Large field radiation therapy 36 Gy, 1.8 Gy/fx/D 5 days/4 weeks, boost 1.8 Gy/D x 2 days, then BID x last 3 days.
干预措施: cisplatin (Drug)
Arm 5
Large field radiation therapy 36 Gy, 1.8 Gy/fx/D 5 days/4 weeks, boost 1.8 Gy/D x 2 days, then BID x last 3 days.
干预措施: etoposide (Drug)
Arm 5
Large field radiation therapy 36 Gy, 1.8 Gy/fx/D 5 days/4 weeks, boost 1.8 Gy/D x 2 days, then BID x last 3 days.
干预措施: radiation therapy (Radiation)
Arm 6
Large field radiation therapy 25.2 Gy, 1.8 Gy/fx/5 days x 14 fx, boost just in pm @ 1.8 Gy/fx on days 15-20, then boost 1.8 Gy BID x last 5 days.
干预措施: cisplatin (Drug)
Arm 6
Large field radiation therapy 25.2 Gy, 1.8 Gy/fx/5 days x 14 fx, boost just in pm @ 1.8 Gy/fx on days 15-20, then boost 1.8 Gy BID x last 5 days.
干预措施: etoposide (Drug)
Arm 6
Large field radiation therapy 25.2 Gy, 1.8 Gy/fx/5 days x 14 fx, boost just in pm @ 1.8 Gy/fx on days 15-20, then boost 1.8 Gy BID x last 5 days.
干预措施: radiation therapy (Radiation)
结局指标
主要结局
Frequency of patients developing unacceptable (grade 3 or higher) acute toxicities attributable to thoracic irradiation with concurrent chemotherapy
时间窗: From start of treatment until 90 days
次要结局
- Compare baseline and follow-up Mini Mental Status Examinations(From baseline until end of follow-up)