A Phase II Trial of Preoperative Irinotecan, Cisplatin and Radiation in Esophageal Cancer
- Determine the pathologic complete response rate in patients with surgically resectable
esophageal cancer treated with neoadjuvant induction chemotherapy comprising cisplatin
and irinotecan hydrochloride (CI) followed by chemoradiotherapy comprising CI and
- Evaluate potential response or progression of disease during induction chemotherapy
with positron emission tomography (PET) scan.
- Evaluate the toxicity and tolerability of this regimen, including surgical morbidity
and mortality, in these patients.
- Determine the overall survival, disease-free survival, and pattern of failure in
patients treated with this regimen.
OUTLINE: This is a multicenter study.
- Induction chemotherapy: Patients receive irinotecan hydrochloride IV over 30-90 minutes
and cisplatin IV over 30 minutes on days 1 and 8 in courses 1 and 2. Treatment repeats
every 21 days for up to 4 courses in the absence of disease progression or unacceptable
- Chemoradiotherapy: Beginning 2 weeks after completion of induction chemotherapy,
patients receive irinotecan hydrochloride and ciplatin as above on days 1 and 8 in
courses 3 and 4 and undergo radiotherapy daily in course 3.Treatment repeats every 21
days for up to 4 courses in the absence of disease progression or unacceptable
- Surgery: Approximately 4-8 weeks after completion of chemoradiotherapy, patients
undergo surgery to remove the tumor.
Patients undergo fludeoxyglucose F 18 positron emission tomography (FDG-PET) imaging at
baseline, 15-19 days after the start of induction chemotherapy, and within 7 days before
After completion of study treatment, patients are followed every 3 months for 2 years and
then every 6 months for 3 years.
PROJECTED ACCRUAL: A total of 90 patients will be accrued for this study.
Masking: Open Label, Primary Purpose: Treatment
Pathologic complete response rate after surgery
David H. Ilson, MD, PhD
Memorial Sloan-Kettering Cancer Center
United States: Federal Government
|Roswell Park Cancer Institute||Buffalo, New York 14263|
|Memorial Sloan-Kettering Cancer Center||New York, New York 10021|
|Memorial Hospital of South Bend||South Bend, Indiana 46601|
|CCOP - Northern Indiana CR Consortium||South Bend, Indiana 46601|
|Saint Joseph Regional Medical Center||South Bend, Indiana 46617|
|Holden Comprehensive Cancer Center at University of Iowa||Iowa City, Iowa 52242-1002|
|Veterans Affairs Medical Center - Buffalo||Buffalo, New York 14215|
|Fletcher Allen Health Care - University Health Center Campus||Burlington, Vermont 05401|
|Maine Center for Cancer Medicine and Blood Disorders - Scarborough||Scarborough, Maine 04074|
|SUNY Upstate Medical University Hospital||Syracuse, New York 13210|
|Wayne Memorial Hospital, Incorporated||Goldsboro, North Carolina 27534|
|CancerCare of Maine at Eastern Maine Medical Center||Bangor, Maine 04401|
|Methodist Estabrook Cancer Center||Omaha, Nebraska 68114-4199|
|Elkhart General Hospital||Elkhart, Indiana 46515|
|Howard Community Hospital||Kokomo, Indiana 46904|
|Lakeland Regional Cancer Care Center - St. Joseph||St. Joseph, Michigan 49085|
|Center for Cancer Therapy at LaPorte Hospital and Health Services||La Porte, Indiana 46350|
|Mountainview Medical||Berlin, Vermont 05602|
|Michiana Hematology-Oncology, PC - South Bend||Mishawaka, Indiana 46545-1470|
|Arthur G. James Cancer Hospital and Richard J. Solove Research Institute at Ohio State University Comprehensive Cancer Center||Columbus, Ohio 43210-1240|
|Elliot Regional Cancer Center at Elliot Hospital||Manchester, New Hampshire 03103|
|Lakes Region General Hospital||Laconia, New Hampshire 03246|
|New Hampshire Oncology - Hematology, PA at Payson Center for Cancer Care||Concord, New Hampshire 03301|
|New Hampshire Oncology - Hematology, PA - Hooksett||Hooksett, New Hampshire 03106|