{"groups":[{"description":"Patients receive either gemcitabine hydrochloride or \\[starting 06-28-2016\\] allowable combination chemotherapy per standard of care for 5 months. Patients undergo CT, MRI, and/or x-ray imaging throughout the trial. Patients also undergo blood sample collection during screening and follow-up and undergo tissue sample collection at baseline.","id":"FG000","title":"Arm I (Gemcitabine Hydrochloride or Combination Chemotherapy)"},{"description":"\\[Closed to accrual 2-28-2014.\\] Patients receive gemcitabine hydrochloride IV over 30 minutes once a week for 3 weeks then off 1 week and erlotinib hydrochloride PO once daily on days 1-28. Treatment repeats every 28 days for up to 5 courses in the absence of disease progression or unacceptable toxicity. Patients undergo CT, MRI, and/or x-ray imaging throughout the trial. Patients also undergo blood sample collection during screening and follow-up and undergo tissue sample collection at baseline.","id":"FG001","title":"Arm II (Gemcitabine Hydrochloride, Erlotinib Hydrochloride)"},{"description":"Patients receive the same treatment as in arm I or arm II for one month. Patients undergo CT, MRI, and/or x-ray imaging throughout the trial. Patients also undergo blood sample collection during screening and follow-up and undergo tissue sample collection at baseline.","id":"FG002","title":"Arm III (Chemotherapy)"},{"description":"Patients receive the same treatment as in arm I or arm II for one month. Beginning within 7-21 days after completion of chemotherapy, patients undergo radiotherapy (3-dimensional conformal radiotherapy or intensity modulated radiotherapy) 5 days per week for 5.5 weeks (28 fractions). During radiotherapy, patients receive either capecitabine PO twice a day (BID) 5 days per week or fluorouracil IV continuously for 5.5 weeks or until radiotherapy is completed. Patients undergo CT, MRI, and/or x-ray imaging throughout the trial. Patients also undergo blood sample collection during screening and follow-up and undergo tissue sample collection at baseline.","id":"FG003","title":"Arm IV (Chemotherapy, Chemoradiotherapy)"}],"periods":[{"dropWithdraws":[{"reasons":[{"groupId":"FG000","numSubjects":"36"},{"groupId":"FG001","numSubjects":"19"},{"groupId":"FG002","numSubjects":"0"},{"groupId":"FG003","numSubjects":"0"}],"type":"Withdrawal by Subject"},{"reasons":[{"groupId":"FG000","numSubjects":"58"},{"groupId":"FG001","numSubjects":"23"},{"groupId":"FG002","numSubjects":"0"},{"groupId":"FG003","numSubjects":"0"}],"type":"Progression"},{"reasons":[{"groupId":"FG000","numSubjects":"15"},{"groupId":"FG001","numSubjects":"10"},{"groupId":"FG002","numSubjects":"0"},{"groupId":"FG003","numSubjects":"0"}],"type":"Did not start 5th cycle of first step treatment"},{"reasons":[{"groupId":"FG000","numSubjects":"3"},{"groupId":"FG001","numSubjects":"4"},{"groupId":"FG002","numSubjects":"0"},{"groupId":"FG003","numSubjects":"0"}],"type":"Death"},{"reasons":[{"groupId":"FG000","numSubjects":"9"},{"groupId":"FG001","numSubjects":"5"},{"groupId":"FG002","numSubjects":"0"},{"groupId":"FG003","numSubjects":"0"}],"type":"Adverse Event"},{"reasons":[{"groupId":"FG000","numSubjects":"4"},{"groupId":"FG001","numSubjects":"6"},{"groupId":"FG002","numSubjects":"0"},{"groupId":"FG003","numSubjects":"0"}],"type":"Other"}],"milestones":[{"achievements":[{"groupId":"FG000","numSubjects":"379"},{"groupId":"FG001","numSubjects":"167"},{"groupId":"FG002","numSubjects":"0"},{"groupId":"FG003","numSubjects":"0"}],"type":"STARTED"},{"achievements":[{"groupId":"FG000","numSubjects":"169"},{"groupId":"FG001","numSubjects":"167"},{"groupId":"FG002","numSubjects":"0"},{"groupId":"FG003","numSubjects":"0"}],"comment":"Closed 02-28-2014.","type":"Randomized to Arm I or Arm II"},{"achievements":[{"groupId":"FG000","numSubjects":"210"},{"groupId":"FG001","numSubjects":"0"},{"groupId":"FG002","numSubjects":"0"},{"groupId":"FG003","numSubjects":"0"}],"comment":"Started 04-02-2014, and as of 06-28-2016, combination chemotherapy was allowed.","type":"Registered to Arm 1 Only"},{"achievements":[{"groupId":"FG000","numSubjects":"363"},{"groupId":"FG001","numSubjects":"159"},{"groupId":"FG002","numSubjects":"0"},{"groupId":"FG003","numSubjects":"0"}],"type":"Eligible"},{"achievements":[{"groupId":"FG000","numSubjects":"163"},{"groupId":"FG001","numSubjects":"159"},{"groupId":"FG002","numSubjects":"0"},{"groupId":"FG003","numSubjects":"0"}],"comment":"Randomized to first step and eligible.","type":"Phase II Analysis Population"},{"achievements":[{"groupId":"FG000","numSubjects":"160"},{"groupId":"FG001","numSubjects":"158"},{"groupId":"FG002","numSubjects":"0"},{"groupId":"FG003","numSubjects":"0"}],"comment":"Randomized to first step, eligible, and started protocol treatment.","type":"Phase II AE Population"},{"achievements":[{"groupId":"FG000","numSubjects":"124"},{"groupId":"FG001","numSubjects":"50"},{"groupId":"FG002","numSubjects":"0"},{"groupId":"FG003","numSubjects":"0"}],"type":"Randomized to Arm III"},{"achievements":[{"groupId":"FG000","numSubjects":"130"},{"groupId":"FG001","numSubjects":"50"},{"groupId":"FG002","numSubjects":"0"},{"groupId":"FG003","numSubjects":"0"}],"type":"Randomized to Arm IV"},{"achievements":[{"groupId":"FG000","numSubjects":"254"},{"groupId":"FG001","numSubjects":"100"},{"groupId":"FG002","numSubjects":"0"},{"groupId":"FG003","numSubjects":"0"}],"comment":"Participants who continued to second step randomization, which requires starting the 5th cycle of the first step treatment and having no progression detected on the 5th cycle CT/MRI.","type":"COMPLETED"},{"achievements":[{"groupId":"FG000","numSubjects":"125"},{"groupId":"FG001","numSubjects":"67"},{"groupId":"FG002","numSubjects":"0"},{"groupId":"FG003","numSubjects":"0"}],"type":"NOT COMPLETED"}],"title":"First Step"},{"milestones":[{"achievements":[{"groupId":"FG000","numSubjects":"0"},{"groupId":"FG001","numSubjects":"0"},{"groupId":"FG002","numSubjects":"174"},{"groupId":"FG003","numSubjects":"180"}],"type":"STARTED"},{"achievements":[{"groupId":"FG000","numSubjects":"0"},{"groupId":"FG001","numSubjects":"0"},{"groupId":"FG002","numSubjects":"174"},{"groupId":"FG003","numSubjects":"180"}],"comment":"Randomized to second step (Arm III and Arm IV).","type":"Phase III Analysis Population"},{"achievements":[{"groupId":"FG000","numSubjects":"0"},{"groupId":"FG001","numSubjects":"0"},{"groupId":"FG002","numSubjects":"174"},{"groupId":"FG003","numSubjects":"180"}],"comment":"Randomized to second step, and started protocol treatment.","type":"Phase III AE Population"},{"achievements":[{"groupId":"FG000","numSubjects":"0"},{"groupId":"FG001","numSubjects":"0"},{"groupId":"FG002","numSubjects":"174"},{"groupId":"FG003","numSubjects":"180"}],"comment":"Contributed any data to phase III analysis or adverse event reporting.","type":"COMPLETED"},{"achievements":[{"groupId":"FG000","numSubjects":"0"},{"groupId":"FG001","numSubjects":"0"},{"groupId":"FG002","numSubjects":"0"},{"groupId":"FG003","numSubjects":"0"}],"type":"NOT COMPLETED"}],"title":"Second Step"}]}