Cisplatin, Irinotecan, and Radiation Therapy in Treating Patients With Esophageal Cancer or Gastroesophageal Junction Cancer That Can Be Removed By Surgery
Esophageal Cancer
About this trial
This is an interventional treatment trial for Esophageal Cancer focused on measuring adenocarcinoma of the esophagus, stage II esophageal cancer, stage III esophageal cancer
Eligibility Criteria
Histologically or cytologically confirmed adenocarcinoma, poorly differentiated carcinoma, or carcinoma not otherwise specified, of the esophagus or gastroesophageal junction; biopsy or cytology of the primary tumor, or of involved regional lymph nodes, is acceptable Tumors must be TNM stage T2-4, N0-1, M0 as determined by pretreatment endoscopic ultrasound; T1 tumors are eligible if they are T1, N1, M0; regional thoracic lymph node involvement (N1) is permitted Disease must be clinically limited to the esophagus or gastroesophageal junction; if the tumor extends below the gastroesophageal junction into the proximal stomach, 50% of the tumor must involve the distal esophagus or gastroesophageal junction; adenocarcinomas of the distal esophagus would therefore include tumors of the distal esophagus, or Siewert type I according to the Siewert classification, and tumors of the gastroesophageal junction which involve equally both the distal esophagus and proximal stomach, or Siewert type II; tumor must be surgically resectable No TIS (in-situ carcinoma) and tumors determined to be T1N0 following endoscopic ultrasound No clinical involvement on endoscopic ultrasound (EUS), computed tomography (CT) scan, or PET scan of supraclavicular or celiac lymph node involvement (stage IVa, T any N any M1a) unless this is proven to be a false positive by an appropriate biopsy No patients with cervical esophageal tumors, or gastric cancers with minor involvement of the gastroesophageal junction or distal esophagus No patients with tracheoesophageal fistulas Patients with evidence of metastatic disease are not eligible; this includes: Positive malignant cytology of the pleura, pericardium or peritoneum Radiographic evidence of distance organ involvement including lung, liver, bone, or brain No prior chemotherapy or radiotherapy is permitted; patients must be at least 4 weeks since major surgery, or must have recovered from the effects of minor surgery (laparoscopy, thoracoscopy) No prior malignancies (other than basal cell/squamous carcinoma of the skin, in-situ cervical carcinoma, or superficial transitional cell bladder carcinoma) are permitted unless diagnosed and/or treated >= 3 years before registration and without evidence of recurrence Eastern Cooperative Oncology Group (ECOG) performance status 0-1 No evidence of recurrent laryngeal nerve or phrenic nerve paralysis No known Gilbert's disease No clinically significant hearing loss; audiograms should be done in patients in which they are clinically indicated No history of active seizure disorder; no ongoing treatment with phenytoin, phenobarbital, or other antiepileptic medication; patients who are receiving valproic acid are eligible No New York Heart Association class III or IV heart disease; no angina or myocardial infarction within the last 6 months Inclusion Criteria: No history of clinically significant ventricular arrhythmia requiring ongoing medication with antiarrhythmics Absolute neutrophil count (ANC) >= 1,500/ul Platelet count >= 100,000/ul Hemoglobin >= 9 gm/dl Serum creatinine =< upper limit of normal (ULN) Total serum bilirubin =< 1.5 mg/dl Forced expiratory volume in 1 second (FEV-1) >= 1.2 liters OR >= 35% of normal as a value that is indexed to body size Pulmonary function tests (PFT) >= 1.2 liters OR >= 35% of normal as a value that is indexed to body size
Sites / Locations
- Elkhart General Hospital
- Howard Community Hospital
- Center for Cancer Therapy at LaPorte Hospital and Health Services
- Saint Joseph Regional Medical Center
- CCOP - Northern Indiana CR Consortium
- Memorial Hospital of South Bend
- Michiana Hematology-Oncology, PC - South Bend
- Holden Comprehensive Cancer Center at University of Iowa
- CancerCare of Maine at Eastern Maine Medical Center
- Maine Center for Cancer Medicine and Blood Disorders - Scarborough
- Lakeland Regional Cancer Care Center - St. Joseph
- Methodist Estabrook Cancer Center
- New Hampshire Oncology - Hematology, PA at Payson Center for Cancer Care
- New Hampshire Oncology - Hematology, PA - Hooksett
- Lakes Region General Hospital
- Elliot Regional Cancer Center at Elliot Hospital
- Veterans Affairs Medical Center - Buffalo
- Roswell Park Cancer Institute
- Memorial Sloan-Kettering Cancer Center
- SUNY Upstate Medical University Hospital
- Wayne Memorial Hospital, Incorporated
- Arthur G. James Cancer Hospital and Richard J. Solove Research Institute at Ohio State University Comprehensive Cancer Center
- Mountainview Medical
- Fletcher Allen Health Care - University Health Center Campus
Arms of the Study
Arm 1
Experimental
Treatment (chemotherapy, chemoradiotherapy, surgery)
INDUCTION CHEMOTHERAPY (COURSES 1-2): Patients receive cisplatin intravenously (IV) over 30 minutes and irinotecan hydrochloride IV over 30-90 minutes on days 1 and 8 of courses 1 and 2. Treatment repeats every 21 days for 2 courses in the absence of disease progression or unacceptable toxicity. CHEMORADIOTHERAPY (COURSES 3-4): Beginning 2 weeks after completion of induction chemotherapy, patients receive cisplatin and irinotecan hydrochloride as in induction chemotherapy on days 1 and 8 of courses 3 and 4 and undergo radiotherapy daily 5 days a week in course 3. Treatment repeats every 21 days for 2 courses in the absence of disease progression or unacceptable toxicity. SURGERY: Approximately 4-8 weeks after completion of chemoradiotherapy, patients undergo surgery to remove the tumor.