A Cancer Research Uk Multicenter Randomized Phase Ii Study Of Induction Chemotherapy Followed By Gemcitabine- Or Capecitabine-Based Chemoradiotherapy For Locally Advanced Nonmetastatic Pancreatic Cancer

TPS222 Background: Around 7,400 patients are diagnosed with pancreatic cancer in the UK each year and mortality from the disease parallels its incidence, indicating that an effective treatment is required. Localized inoperable cancer accounts for 30-40% of advanced disease and its optimal management is unclear. Chemotherapy alone is the predominant modality in the UK while CRT is the treatment of choice in the USA. It has been reported that participants receiving either modality have a median survival in the region of 10 months. Nonrandomized studies have shown that selected participants who attain stable or responsive disease after 3 to 4 months of induction chemotherapy may benefit from consolidation CRT. Both gemcitabine and capecitabine have been shown to be potential radiosensitisers. Methods: The Cancer Research UK funded National Cancer Research Institute SCALOP trial is a two-arm randomized phase II trial using a Fleming's single stage design for each arm. Patients will receive 16 weeks of GEMCAP induction chemotherapy; 76 of those who have responded, or have stable disease, will then be randomised to receive 5.5 weeks of either gemcitabine- or capecitabine-based consolidation chemoradiation (50.4 Gy in 28 fractions with either gemcitabine 300 mg/m2 weekly or capecitabine 830mg/m2 bd ). The trial will assess: 1) What are the activity, toxicity, and feasibility of use of the regimens and does either justify consideration as an arm in a future phase III trial? 2) Is it possible to deliver high quality CRT across centres in the UK? 3) In participants who progress following induction chemotherapy, what is the pattern of care in UK centres and what is their prognosis? The trial incorporates a radiotherapy quality assurance element consisting of a radiotherapy protocol, a test case that must be successfully completed before recruitment can begin at a centre, and ongoing assessment of all plans for compliance with protocol. The trial will also store blood samples for future translational studies. The trial has just opened to recruitment in 5 centers in the UK with 23 further centers in set up. No significant financial relationships to disclose.