IMRT Combined With Carboplatin Versus IMRT Combined With Carboplatin and Fluorouracil in the Treatment of Locally Advanced Esophageal Cancer in Elderly Patients With High Risk of Chemotherapy: a Randomized Controlled Clinical Study
试验速览
- 阶段
- 2 期
- 发起方
- 入组人数
- 264
- 试验地点
- 1
- 主要终点
- Overall objective response rate
研究概览
简要总结
An open, single-center, randomized controlled phase II clinical trial to compare the efficacy and safety of conformal intensity modulated radiation therapy (IMRT) combined with carboplatin and IMRT combined with carboplatin and 5-FU in elderly patients with locally advanced esophageal squamous cell carcinoma at high risk of chemotherapy
详细描述
Esophageal cancer is one of the most common malignant tumors in China.To compare the efficacy and safety of conformal intensity modulated radiation therapy (IMRT) combined with carboplatin and IMRT combined with carboplatin and 5-FU in elderly patients with locally advanced esophageal squamous cell carcinoma at high risk of chemotherapy.This trial is an open, single-center, randomized controlled phase II clinical trial.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Treatment
- 盲法
- Single (Participant)
入排标准
- 年龄范围
- 65 Years 至 85 Years（Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Age (> 65 years)
- •Histologically confirmed esophageal squamous cell carcinoma, the 8th edition of AJCC stage T3-4NxM0 or TxN1-3M0, without surgical indications after consultation by surgeons.
- •PS score < 2, Chemotherapy risk score is medium and high risk
- •No radical thoracic surgery/chemotherapy/radiotherapy/targeted therapy has been performed in the past.
- •Diseases measurable according to RECIST standards
- •Hematological examination requires Hb (>90g/L), ANC (>2.0 *109/L) and platelet (>100 *109/L). Serum albumin (>3.0g/dL)
- •Serum creatinine < 1.25 times normal upper limit (UNL), or creatinine clearance rate (>60 ml/min). Total bilirubin < upper limit of normal value
- •Total bilirubin < the upper limit of normal value, AST (SGOT) and ALT (SGPT) < 2.5 times the upper limit of normal value, ALP < 2.5 times the upper limit of normal value (ULN)
- •If exploratory surgery is performed, the patient will recover at least 2 weeks after operation.
排除标准
- •Pregnant or lactating women.
- •Patients with fertility without adequate contraceptive measures.
- •Anaphylaxis to 5FU and carboplatin is known.
- •Anaphylaxis known to exist with any drug in the study
- •Other malignant tumors have occurred in the past five years, except cervical carcinoma in situ or non-melanoma skin cancer, which has been properly treated.
- •Discovery of esophageal fistula or risk of esophageal bleeding before treatment
- •Distant organ metastasis is known
- •Symptomatic peripheral neuropathy, according to NCIC-CTC criteria (> grade 2).
- •Other serious diseases or medical conditions: Myocardial infarction (in the past six months), severe unstable angina pectoris and congestive heart failure have occurred.
- •Severe complications (including intestinal paralysis, intestinal obstruction, interstitial pneumonia, pulmonary fibrosis, severe respiratory dysfunction of COPD, cardiac dysfunction of pulmonary heart disease, uncontrolled diabetes mellitus, renal insufficiency and cirrhosis of liver, etc.)
- •Gastrointestinal bleeding requires frequent blood transfusion.
- •It is known to carry human immunodeficiency virus (HIV) or AIDS.
- •Suffering from mental illness
- •The known neuropathy is of grade 2 or higher severity.
研究组 & 干预措施
IMRT combined with carboplatin
Intensity modulated radiation therapy 50-60Gy, Carboplatin (AUC 2), QW1, intravenous drip, repeat for 4 weeks
干预措施: Intensity modulated radiation therapy (Radiation)
IMRT combined with carboplatin
Intensity modulated radiation therapy 50-60Gy, Carboplatin (AUC 2), QW1, intravenous drip, repeat for 4 weeks
干预措施: carboplatin (Drug)
IMRT combined with carboplatin and fluorouracil
Intensity modulated radiation therapy 50-60Gy, Carboplatin (AUC 2), QW1, intravenous drip; Fluorouracil 1.33g/body surface QW1, continuous intravenous infusion for 72 hours, repeated for 4 weeks
干预措施: Fluorouracil (Drug)
IMRT combined with carboplatin and fluorouracil
Intensity modulated radiation therapy 50-60Gy, Carboplatin (AUC 2), QW1, intravenous drip; Fluorouracil 1.33g/body surface QW1, continuous intravenous infusion for 72 hours, repeated for 4 weeks
干预措施: Intensity modulated radiation therapy (Radiation)
IMRT combined with carboplatin and fluorouracil
Intensity modulated radiation therapy 50-60Gy, Carboplatin (AUC 2), QW1, intravenous drip; Fluorouracil 1.33g/body surface QW1, continuous intravenous infusion for 72 hours, repeated for 4 weeks
干预措施: carboplatin (Drug)
结局指标
主要结局
Overall objective response rate
时间窗: up to 24 months
The proportion of partial and complete remission of tumors
次要结局
- Incidence of toxic and side effects above 3 degrees(up to 24 months)
研究者
Zhu Yujia
Doctor
Sun Yat-sen University