Summaries - Gastrointestinal Gastrointestinal Cancer Protocols RTOG 0436 Number: RTOG 0436 Title: A Phase III Trial Evaluating the Addition of Cetuximab to Paclitaxel, Cisplatin, and Radiation for Patients with Esophageal Cancer Who Are Treated without Surgery Eligibility: Pathologically proven diagnosis of primary squamous cell or adenocarcinoma of the esophagus or gastroesophageal junction within 12 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; Zubrod performance status 0-2; Age > 18; Adequate bone marrow function as specified in the protocol; 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 invasive malignancy (except non-melanomatous skin cancer) unless disease free for a minimum of 2 years; No prior systemic chemotherapy for esophageal cancer; note that prior chemotherapy for a different cancer is allowable; No prior chest radiotherapy; No prior therapy that specifically and directly targets the EGFR pathway; No prior platinum-based and/or paclitaxel-based therapy. No prior allergic reaction to the study drugs involved in this protocol; No prior severe infusion reaction to a monoclonal antibody; No severe, active comorbidity as defined in the protocol; Pregnant or nursing women or women of childbearing potential and men who are sexually active and not willing/able to use medically acceptable forms of contraception are excluded; Patients must provide study-specific informed consent prior to study entry. Radiochemotherapy +/- cetuximab: Arm 1: Radiation Therapy + Paclitaxel + Cisplatin + Cetuximab Arm 2: Radiation Therapy + Paclitaxel + Cisplatin Study size: 420 RTOG 0848 Number: RTOG 0848 Title: A Phase III Trial Evaluating Both Erlotinib and Chemoradiation as Adjuvant Treatment for Patients with Resected Head of Pancreas Adenocarcinoma Eligibility: 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; Age > 18; Zubrod performance status 0 or 1; Complete history and physical examination including weight and Zubrod status within 31 days of study entry; 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; CBC/differential obtained within 21 days of registration on study, with adequate bone marrow function defined as follows: Absolute neutrophil count (ANC) > 1,500 cells/mm3 ; Platelets > 100,000 cells/mm3; Hemoglobin > 8.0 g/dl (Note: The use of transfusion or other intervention to achieve Hgb > 8.0 g/dl is acceptable.); 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 study; Negative serum pregnancy test for women of childbearing potential within 14 days of study registration; Abdominal/pelvic CT scan with contrast and chest CT/x-ray (CT of chest preferred) within 31 days of registration on study. Patients allergic to IV contrast can have MRI of the abdomen/pelvis instead; A tumor tissue block and peripheral blood must be submitted to this study's central tumor bank for correlative studies; Signed study-specific informed consent; Consultation, agreement, and documentation in the patient's chart by a radiation oncologist that patient is suitable to receive radiotherapy per this protocol; Women of childbearing potential and male participants must practice adequate contraception; Patients with active HIV infection are eligible if their CD4 count is > 499/cu mm and their viral load is < 50 copies/ml; use of HAART is allowed. 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 Study size: 950