Adult Clinical Trials: GASTROINTESTINAL

 RTOG 0436 Gastrointestinal 

A Phase III Trial Evaluating the Addition of Cetuximab to Paclitaxel, Cisplatin, and Radiation for Patients with Esophageal Cancer Who Are Treated without Surgery

• Histologically proven diagnosis of primary squamous cell or adenocarcinoma of the esophagus or gastroesophageal junction within 6 weeks prior to registration.
• 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.
• Disease must be encompassed in a radiotherapy field; Patients with celiac, perigastric, mediastinal or supraclavicular adenopathy are eligible.
• Patients with cervical esophageal carcinoma are eligible; Stage T1N1M0; T2-4, Any N, M0; Any T, Any N, M1a.
• Patient's total intake (oral/enteral) must be > 1500 kCal/day.
• Evidence of tracheoesophageal fistula, 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; note that prior chemotherapy for a different cancer is allowable.
• No prior chest radiotherapy.
• No severe, active comorbidity as defined in the protocol. 

Treatment

Arm 1:  Radiation Therapy + Paclitaxel + Cisplatin + Cetuximab 

Arm 2:  Radiation Therapy + Paclitaxel + Cisplatin 

RTOG 0848  

A Phase III Trial Evaluating Both Erlotinib and Chemoradiation as Adjuvant Treatment for Patients with Resected Head of Pancreas Adenocarcinoma

• Histologic proof of primary head of pancreas invasive adenocarcinoma managed with a potentially curative resection (i.e., removal of all gross tumor) involving a classic pancreaticoduodenectomy (Whipple) or a pylorus preserving pancreaticoduodenectomy;
• Patients with invasive adenocarcinoma that also contains a component of intraductal papillary mucinous neoplasm (IPMN) are eligible;
• Interval between definitive tumor-related surgery and 1st step registration between 21-56 days; Patients will be staged according to the 6th edition AJCC staging system with pathologic stage T1-3, N0-1, M-0 being eligible.
• Pathologic reporting using the CAPS format is strongly encouraged;
• Zubrod performance status 0 or 1;
• Before starting therapy the patient should be able to maintain adequate oral nutrition of 1500 calories estimated caloric intake per day and be free of significant nausea and vomiting
• Post resection serum CA19-9 < 180 units/mL within 21 days of registration on study;
• Creatinine levels < twice the institutional upper limit of normal within 21 days of registration on study; SGOT must be < 2.5 x the institutional upper limit of normal within 21 days of registration on
• A tumor tissue block and peripheral blood must be submitted to this study's central tumor bank for correlative studies 

Treatment

Ist Randomization  

Arm 1:  gemcitabine x 5 cycles
Arm 2:  gemcitabine + erlotinib x 5 cycles

Evaluate to confirm no progression

2nd Randomization  

Arm 3:  1 cycle same chemotherapy as first randomization treatment arm 
Arm 4:  1 cycle same chemotherapy as first randomization treatment arm followed by XRT + capecitabine or 5-FU