This phase II trial studies how well giving cisplatin and irinotecan hydrochloride together with radiation therapy works in treating patients with esophageal cancer or gastroesophageal junction cancer that can be removed by surgery. Drugs used in chemotherapy, such as cisplatin and irinotecan hydrochloride, work in different ways to stop the growth of tumor cells, either by killing the cells or by stopping them from dividing. Radiation therapy uses high-energy x-rays to kill tumor cells. Giving combination chemotherapy together with radiation therapy before surgery may make the tumor smaller and reduce the amount of normal tissue that needs to be removed.
PRIMARY OBJECTIVES: I. To determine the pathologic complete response rate in patients with surgically resectable esophageal cancer treated pre-operatively with induction chemotherapy with weekly cisplatin and irinotecan (irinotecan hydrochloride) followed by concurrent cisplatin/irinotecan and radiation therapy. SECONDARY OBJECTIVES: I. To evaluate potential response or progression of disease during induction chemotherapy with positron emission tomography (PET) scan. II. To evaluate the toxicity and tolerability of therapy, including surgical morbidity and mortality. III. To determine the overall survival, disease free survival, and pattern of failure. OUTLINE: 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. After completion of study treatment, patients are followed up every 3 months for 2 years and then every 6 months for 3 years.
Study Type
INTERVENTIONAL
Allocation
NA
Purpose
TREATMENT
Masking
NONE
Enrollment
82
Given IV
Given IV
Undergo Surgery
Undergo radiation
Elkhart General Hospital
Elkhart, Indiana, United States
Howard Community Hospital
Kokomo, Indiana, United States
Center for Cancer Therapy at LaPorte Hospital and Health Services
La Porte, Indiana, United States
Saint Joseph Regional Medical Center
Mishawaka, Indiana, United States
CCOP - Northern Indiana CR Consortium
South Bend, Indiana, United States
Proportion of Patients With Adenocarcinoma Achieving a Pathologic Complete Response (CR) After Surgery
A pathological complete response is defined as no tumor found on pathology review at surgery in all resected lymph nodes and tissue. All tissues sampled must have NO viable tumor
Time frame: Up to 5 years
Utility of Early PET Imaging in Predicting Response to Treatment
Time frame: Up to 55 days
Disease-free Survival
Time frame: Up to 5 years
Overall Survival
Time frame: Up to 5 years
Patterns of Failure
Time frame: Up to 5 years
Proportion of Patients Experiencing Grade 3 or Greater Pneumonitis or Esophagitis
Proportion of patients experiencing grade 3 or greater pneumonitis or esophagitis, deemed at least possibly related to treatment graded using the National Cancer Institute (NCI) Common Terminology Criteria for Adverse Events (CTCAE) version 3.0
Time frame: Up to 5 years
Proportion of Patients Experiencing Grade 3 or Greater Hematologic and Non-hematologic Toxicity
Proportion of patients experiencing grade 3 or greater hematologic and non-hematologic toxicity, deemed as at least possibly related to treatment, graded using the NCI CTCAE version 3.0
Time frame: Up to 5 years
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