Esophageal Cancer Clinical Trial
Proton Therapy for Esophageal Cancer
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.
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
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
Age ≥ 18
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
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
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