Status:
COMPLETED
Sutent Following Chemotherapy, Radiation and Surgery For Resectable Esophageal Cancer
Lead Sponsor:
University Health Network, Toronto
Collaborating Sponsors:
Pfizer
Conditions:
Esophageal Cancer
Eligibility:
All Genders
18-70 years
Phase:
PHASE2
Brief Summary
The purpose of this study is to see whether or not the combination of cisplatin, irinotecan and radiation, followed by surgery, followed by oral Sutent, is effective and safe for patients with resecta...
Detailed Description
Survival outcomes for resectable esophageal cancer remain poor. Current data strongly support an adjuvant systemic strategy to improve time to progression and survival in this patient population. Addi...
Eligibility Criteria
Inclusion
- Histologically proven squamous or adenocarcinoma or the esophagus \>20 cm from the incisors, including GE junction tumors (unless of gastric origin).
- Tumors must be technically resectable.
- Clinical T1N1M0, T2-3 N0-1 M0
- Performance status ECOG 0-1
- Medically fit for chemotherapy, radiation and esophagectomy
Exclusion
- In situ or clinical T1N0M0, and stage IV (M1a orM1b)
- Cervical esophageal tumors (within 20 cm of the incisors)
- Age \<18 or \>70
- Participation in another concurrent clinical study involving study drug(s) or treatment with study drug within thirty days prior to the treatment on this study. Concurrent treatment with other experimental drugs or anticancer therapy
- known or suspected drug or alcohol abuse
- Prior treatment for this malignancy except esophageal stenting
Key Trial Info
Start Date :
September 25 2006
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
September 19 2016
Estimated Enrollment :
36 Patients enrolled
Trial Details
Trial ID
NCT00400114
Start Date
September 25 2006
End Date
September 19 2016
Last Update
May 8 2017
Active Locations (2)
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1
The Ottawa Hospital Regional Cancer Centre
Ottawa, Ontario, Canada, K1H 8L6
2
University Health Network (Princess Margaret & Toronto General Hospitals)
Toronto, Ontario, Canada, M5G 2C4