A Phase II Trial of Proton Chemotherapy (PCT) for Resectable Esophageal or Esophagogastric Junction Cancer
试验速览
- 阶段
- 不适用
- 状态
- 招募中
- 入组人数
- 38
- 试验地点
- 2
- 主要终点
- To assess overall survival of patients treated with proton-chemotherapy (PCT) followed by surgery in patients with resectable primary esophageal or esophagogastric cancer
研究概览
简要总结
The goal of this phase II study is to investigate the feasibility, toxicity and efficacy of a regimen incorporating a proven systemic regimen, carboplatin /paclitaxel, with conformal proton modality, followed by definitive surgery. In most combined-modality trials to date, chemotherapy regimens have included cisplatin, usually in conjunction with 5-fluorouracil.
In designing the regimen, the investigators attempt to improve on the standard cisplatin/5-fluorouracil regimen in several ways. First, full-dose paclitaxel is added to the regimen. This agent has activity against advanced esophageal cancer and is also a potent radiosensitizer. Second, the substitution of carboplatin for cisplatin has resulted in reduced toxicity of various combination regimens similar to that used by CROSS trial and allows for easier administration in the outpatient setting.4 Third, for localized esophageal cancer, dose distribution patterns achievable with proton beam could potentially offer important clinical advantages relative to those achievable with x-rays (photons).19 Based on this, the investigators believe that this study should be conducted with the radiation modality that offers the best dosimetry achievable at our institution.
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
- •Pathologically confirmed primary squamous cell or adenocarcinoma of the esophagus that involves the mid, distal or esophagogastric junction. The cancer may involve the stomach up to 5 cm.
- •Endoscopy with biopsy
- •Stage T1N102, T2-3N0-2 according to the American Joint Committee on Cancer (AJCC) 7th edition staging, based upon the following minimum diagnostic work-up:
- •History/physical examination with documentation of patient's weight within 30 days of registration
- •Chest/Abdominal/Pelvic contrast CT within 56 days of registration
- •Whole body PET/CT within 56 days of registration
- •Endoscopic ultrasound
- •Patients may have regional adenopathy including para-esophageal, gastric, gastroheptaic and celiac nodes. If celiac adenopathy present, it must be ≤ 2cm.
- •Patients with tumors at the level of the carina or above should undergo bronchoscopy to exclude fistula
- •Pulmonary function test (including routine spirometry and DLCO) within 60 days prior to registration
- •Serum creatinine ≤ 2 x the upper limit of normal within 4 weeks of registration
- •Na, K, BUN, Glucose within 4 weeks prior to registration
- •CBC/differential within 4 weeks prior to registration with adequate bone marrow function, defined as follows:
- •Absolute neutrophil count (ANC) ≥ 1,500 cells/mm3
- •Platelets ≥ 100,000 cell/mm3
- •Hemoglobin ≥ 8.0 g/dl (Note: the use of transfusion or other intervention to achieve Hgb ≥ 8.0 is acceptable.)
- •Adequate liver function, defined as total bilirubin ≤ 1.5 x upper limit of normal, AST ≤ 3 x the upper limit of normal within 4 weeks of registration
- •Zubrod performance status 0-2 within 4 weeks of registration
- •Surgical consultation to confirm that patient will be able to undergo curative resection after completion of PCT prior to registration
- •For women of childbearing potential, a negative serum pregnancy test within 14 days prior to registration
- •Women of childbearing potential and male participants must practice adequate contraception while on study
- •Patient must sign study specific informed consent prior to study entry
排除标准
- •Patients with cervical esophageal carcinoma
- •Patients with T1N0 disease and T4 disease
- •Prior radiation for esophageal cancer or prior chest radiotherapy
- •Prior chemotherapy for esophageal cancer
- •Evidence of tracheoesophageal fistula or invasion into the trachea or major bronchi
- •Prior invasive malignancy (except non-melanomatous skin cancer), unless disease free for a minimum of 2 years ( e.g. carcinoma in situ of breast, oral cavity, or cervix are permissible)
- •Prior radiotherapy that would results in overlap of radiation fields
- •Medical contraindications to esophagectomy
- •Prior allergic reaction to paclitaxel or carboplatin
- •Severe, active co-morbidity that may impact survival
- •Pregnancy, nursing women, or women of child bearing potential, and men who are sexually active and not willing/able to use medically acceptable forms of contraception
研究组 & 干预措施
Proton radiation
Proton radiation
干预措施: Proton radiation (Radiation)
结局指标
主要结局
To assess overall survival of patients treated with proton-chemotherapy (PCT) followed by surgery in patients with resectable primary esophageal or esophagogastric cancer
时间窗: The major analysis for reporting the initial results of treatment will be undertaken when each patient has been potentially followed for a minimum of 3 months
次要结局
- Number of participants with adverse events as a measure of safety and tolerability(The major analysis for reporting the initial results of treatment will be undertaken when each patient has been potentially followed for a minimum of 3 months)