A Phase 2 Study of Palliative Chemo-Radiotherapy With Carbo-Taxol in Non-Curative Cancer of the Esophagus
试验速览
- 阶段
- 2 期
- 状态
- 招募中
- 入组人数
- 50
- 试验地点
- 1
- 主要终点
- Proportion of patients who achieve relief of dysphagia
研究概览
简要总结
This study aims to show that the addition of carboplatin and paclitaxel chemotherapy to a palliative course of external beam radiation treatment improves both dysphagia relief and patient quality of life in patients with unresectable esophageal cancer.
详细描述
Patients with carcinoma of the esophagus not suitable for definitive radical treatment who have symptomatic dysphagia requiring locoregional palliation, and who have no contra-indications to chemo-radiotherapy will be offered Carboplatin (AUC 2) and paclitaxel (50 mg/m2) intravenously on days 1 and 8 concurrent with external beam radiation therapy of 30Gy/10 fractions over two weeks where the primary goal is relief of dysphagia and other outcomes include toxicity, quality of life and metabolomics.
研究设计
- 研究类型
- Interventional
- 分配方式
- Na
- 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 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Biopsy proven carcinoma of the esophagus.
- •Not a candidate for radical/curative treatment due to the advanced nature of the disease, presence of metastases, or intercurrent illness.
- •Symptomatic patients with Mellow Dysphagia Scores of ≥ 1 i.e. able to eat only some solids.
- •ECOG Performance status ≤
- •Patients able to begin treatment within 14 days of signing the informed consent form.
- •Patient is at least 18 years old.
- •Hematological function as defined by the following laboratory parameters:
- •Hemoglobin > 100g/L
- •Platelet count > 100x10E9/L
- •Absolute neutrophil count > 1.5x10E9/L
- •Renal function to undergo chemotherapy as defined by the following laboratory parameters:
- •Aspartate aminotransferase (AST) and alanine aminotransferase (ALT) ≤ 2.5x the upper limit of institutional normal (≤ 5 if liver metastases)
- •Total bilirubin ≤ 1.5x the upper limit of institutional normal
- •Calculated creatinine clearance ≥ 50 mL/min using the Cockcroft-Gault formula
- •Patients capable of childbearing are using adequate contraception.
- •Written and informed consent of patient.
排除标准
- •Previous radiotherapy delivered to the chest.
- •Synchronous active malignancies.
- •Pregnant or lactating patients: women of child bearing potential must have a negative serum pregnancy test within 7 days of Treatment Visit
- •Women or men of child bearing potential must use effective contraception (defined by the use of two birth control methods, which can be either two barrier methods or a barrier method plus a hormonal method to prevent pregnancy). Subjects must start using birth control from the time they have signed the Informed Consent Form prior to start of therapy until 120 days post completion of study therapy or study discontinuation, which must be documented in the eCRF.
- •Patients unfit for any treatment component, including absolute contraindications for radiotherapy or Connective Tissue Disease.
- •Tracheo-esophageal fistula.
- •Esophageal stents in situ.
- •Previous chemotherapy for esophageal cancer
- •Unable to complete surveys in English without aid of interpreter.
研究组 & 干预措施
Chemotherapy with Concurrent Radiation
Carboplatin and paclitaxel will be administered intravenously on Days 1 and 8 while radiation therapy is administered
干预措施: Carboplatin and Taxol (paclitaxel) (Drug)
Chemotherapy with Concurrent Radiation
Carboplatin and paclitaxel will be administered intravenously on Days 1 and 8 while radiation therapy is administered
干预措施: External Beam Radiation (Radiation)
结局指标
主要结局
Proportion of patients who achieve relief of dysphagia
时间窗: up to day 85
Will be measured as the proportion of patients who achieve relief of dysphagia, defined as improvement of at least one point on the Mellow Dysphagia Score, measured at Day 57 after the start of radiotherapy, and maintained for at least 28 calendar days (until the Day 85 visit).
次要结局
- Dysphagia progression free survival(6 Months)
研究者
Marc Kerba
MD
AHS Cancer Control Alberta