Status:
COMPLETED
Preoperative Chemotherapy vs. Chemoradiation in Esophageal / GEJ Adenocarcinoma
Lead Sponsor:
Dr. Gordon Buduhan
Collaborating Sponsors:
CancerCare Manitoba
University of Toronto
Conditions:
Esophageal Cancer
Adenocarcinoma, Esophageal
Eligibility:
All Genders
18-99 years
Phase:
PHASE2
PHASE3
Brief Summary
The best treatment for resectable esophageal or gastroesophageal adenocarcinoma is unknown. Although an operation to remove the esophagus is the most common treatment, previous studies have shown that...
Detailed Description
OBJECTIVE To determine the feasibility of a randomized trial of neoadjuvant chemotherapy vs. neoadjuvant chemoradiation for patients with resectable adenocarcinoma of the esophagus or gastroesophageal...
Eligibility Criteria
Inclusion
- Inclusion Criteria:
- adenocarcinoma of esophagus or gastroesophageal junction; -cT1N1-3 or T2-4Nx; M0 by American Joint Committee on Cancer (AJCC) 7th Edition staging classification
- proximal portion of the tumor at least 20 cm from the incisors on endoscopy, and extend no greater than 2 cm into the gastric cardia
- tumor length \< 8cm; diameter \< 5 cm
- age \> 18 years
- absolute neutrophil count (ANC) ≥ 1.5 x 109 / L
- platelet count \> 100 x 109 / L
- creatinine clearance \> 50 ml / min
- bilirubin \< 1.5x upper limit normal
- FEV1 \> 1.0 L
- Eastern Cooperative Oncology Group (ECOG) performance status 0-2
- Exclusion Criteria
- positive serum / urine pregnancy test for females of childbearing age
- previous primary / recurrent malignancy in last 5 years (history of previous / current non-melanoma skin cancer or cervical in-situ carcinoma in last 5 years acceptable for inclusion in trial)
- previous chemotherapy for esophageal cancer
- previous radiation therapy that would overlap required radiation fields
- major systemic illness(es) that would limit life expectancy \<2 years
- psychiatric / cognitive illness that would limit ability to give informed consent
- (Patients will be reviewed by both a medical and radiation oncologist and deemed fit to undergo either neoadjuvant chemotherapy or chemoradiation, respectively)
Exclusion
Key Trial Info
Start Date :
September 1 2015
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
August 1 2023
Estimated Enrollment :
29 Patients enrolled
Trial Details
Trial ID
NCT01404156
Start Date
September 1 2015
End Date
August 1 2023
Last Update
August 28 2024
Active Locations (3)
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1
Health Sciences Centre / CancerCare Manitoba
Winnipeg, Manitoba, Canada, R3A 1R9
2
London Health Sciences Centre
London, Ontario, Canada, N6A 5W9
3
Toronto General Hospital / Princess Margaret Hospital
Toronto, Ontario, Canada