Phase II Trial of Cetuximab, Irinotecan, Cisplatin (CPC), Concurrent Radiation Therapy, and Surgery for Resectable Esophageal Cancer
- Patients participating in this study must have a tumor biopsy taken to confirm the type
- Outpatient therapy with cetuximab alone will be given intravenously on week 0.
- During week 1-8 outpatient radiation therapy will be started and continued once per day
for 28 treatments or 5 1/2 weeks.
- Outpatient chemotherapy (cisplatin, irinotecan and cetuximab) is given once per week on
weeks 1, 2, 4, and 5. Cetuximab alone will be given on weeks 3, 6, 7, and 8.
- A repeat CT scan and PET scan will be performed to restage the tumor on week 8. This is
to confirm that the cancer has remained localized.
- Inpatient surgery is scheduled 4 to 8 weeks after completion of chemotherapy and
- Cetuximab will be restarted within 4 weeks after surgery and continue weekly for 6
- During chemotherapy and radiation therapy, physical exams and vital signs will be
performed before each chemotherapy treatment. Routine blood tests will also be
- Between chemotherapy-radiation therapy and surgery a CAT scan of chest, abdomen and
pelvis along with a PET scan will be performed.
- After surgery a CAT scan of chest, abdomen and pelvis will be performed every 3 months
for 2 years then every 6 months for 3 years. An EGD (upper endoscopy) with biopsy will
be done every 6 months for 2 years and then yearly for 3 years. Physical exam, vital
signs and routine blood tests will be done every 2 weeks for 6 months, then every 3
months for 1.5 years, and then every 6 months for 3 years.
Allocation: Non-Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment
To determine the response to the combination of cetuximab, cisplatin, irinotecan, and radiation therapy in resectable esophageal carcinoma.
Peter Enzinger, MD
Dana-Farber Cancer Institute
United States: Institutional Review Board
|Dana-Farber Cancer Institute||Boston, Massachusetts 02115|
|Massachusetts General Hospital||Boston, Massachusetts 02114-2617|