RTOG 0436 - A Phase III Trial Evaluating the Addition of Cetuximab to Paclitaxel, Cisplatin and Radiation for Patients With Esophageal Cancer Who Are Treated Without Surgery
Description
RTOG 0436 - A Phase III Trial Evaluating the Addition of Cetuximab to Paclitaxel, Cisplatin and Radiation for Patients With Esophageal Cancer Who Are Treated Without Surgery
Primary:
To evaluate whether the addition of cetuximab to chemotherapy comprising paclitaxel, cisplatin, and radiotherapy improves overall survival compared with paclitaxel, cisplatin, and radiotherapy alone in patients with esophageal cancer treated without surgery.
Secondary:
To evaluate whether the addition of cetuximab to paclitaxel, cisplatin, and radiotherapy improves local control by increasing the clinical complete response and decreasing local recurrence in these patients.
To evaluate adverse events in these patients.
To evaluate endoscopic complete response rates in these patients.
To evaluate if the addition of cetuximab to paclitaxel, cisplatin, and radiotherapy improves the Esophageal Cancer Subscale score of the FACT-E quality of life tool.
To evaluate the quality-adjusted survival of each treatment arm using EQ-5D if the primary endpoint supports the primary hypothesis.
Study/Treatment
GI Tract Cancer
Inclusion/Notes
Eligibility Criteria:
Age > 18 – 74 years.
Histologically confirmed primary squamous cell or adenocarcinoma of the esophagus or gastroesophageal junction
Patients with involvement of the gastroesophageal junction with Siewert type I or II tumors (tumors arising from the distal esophagus and involving the esophagogastric junction or tumors starting at the esophagogastric junction and involving the cardia) are eligible
Patients with cervical esophageal carcinoma are eligible
Patients with celiac, perigastric, mediastinal, or supraclavicular adenopathy are eligible
Stage T1, N1, M0; T2-4, Any N, M0; or Any T, Any N, M1a disease based on history/physical examination, endoscopy with biopsy, AND PET/PET-CT scan or chest/abdominal CT scan within 6 weeks prior to registration
Disease must be encompassed in a radiotherapy field
No evidence of tracheoesophageal fistulas or invasion into the trachea or major bronchi
Patients with T3-4 proximal thoracic esophageal tumors (15-25 cm) must undergo bronchoscopy to exclude fistula
No prior systemic chemotherapy for esophageal cancer (prior chemotherapy for another cancer allowed)
No prior therapy that specifically and directly targets the EGFR pathway
No prior platinum-based and/or paclitaxel-based therapy
No prior radiotherapy that would result in overlap of planned study radiotherapy fields
No concurrent investigational agent
No concurrent cytotoxic agent
No other concurrent radiotherapy
Zubrod performance status 0-2
ANC = 1,500/mm³
Platelets = 100,000 cells/mm³
Hemoglobin = 8.0 g/dL (transfusion or other intervention to achieve Hgb = 8.0 g/dL allowed)
Creatinine = 1.5 mg/dL
Bilirubin = 1.5 times upper limit of normal (ULN)
AST = 3 times ULN
Negative pregnancy test
Not pregnant or nursing
Fertile patients must use effective contraception
Total intake (oral/enteral) must be = 1,500 kCal/day
No prior invasive malignancy except nonmelanomatous skin cancer (e.g., carcinoma in situ of the breast, oral cavity, or cervix) unless disease-free for = 2 years
No prior allergic reaction to the study drugs
No prior severe infusion reaction to a monoclonal antibody
No severe, active comorbidity, including any of the following:
Start Date
01/18/2011
Principal Name
John A. Pablo, M.D.
Contact Name
Nancy N. and J.C. Lewis Cancer & Research Pavilion
Fax
(912) 819-5705
Phone
(912) 819-5704
Nancy N. and J.C. Lewis Cancer & Research Pavilion225 Candler Drive, Savannah, Georgia 31405
