• Adult Clinical Trials: GASTROINTESTINAL

    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