A Phase II Trial of Preoperative Irinotecan, Cisplatin and Radiation in Esophageal Cancer
OBJECTIVES:
Primary
- 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
radiotherapy.
Secondary
- 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
toxicity.
- 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
toxicity.
- 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
beginning chemoradiotherapy.
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.
Interventional
Masking: Open Label, Primary Purpose: Treatment
Pathologic complete response rate after surgery
No
David H. Ilson, MD, PhD
Study Chair
Memorial Sloan-Kettering Cancer Center
United States: Federal Government
CDR0000468495
NCT00316862
February 2006
Name | Location |
---|---|
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 |