Phase I Study of TS-1 With Concurrent Radiotherapy to Treat Pancreatic Cancer

A Phase I Study of TS-1 With Concurrent Radiotherapy Followed by Gemcitabine and TS-1 in Metastatic Pancreatic Cancer (SR-GS Study)

The purpose of this study is to determine whether combination of TS-1 and concurrent and short-course radiotherapy is feasible in metastatic pancreatic cancer. The rationale of this study primarily bases on the good efficacy of gemcitabine plus TS-1 and the great potential of local control of concurrent chemoradiotherapy in pancreatic cancer.

Inclusion Criteria:

• histologically or cytologically proven, newly diagnosed pancreatic adenocarcinoma or adenosquamous carcinoma
• no previous radiotherapy, chemotherapy, targeted therapy, curative surgery, or immunotherapy used for pancreatic cancer
• presence of at least one measurable lesion, which must meet the criteria of being ≥ 20 mm in at least one dimension by conventional CT/MRI or ≥ 10 mm by spiral CT scan
• age between 20 and 79 years at registration
• ECOG PS of 0 or 1
• adequate major organ functions
• ability to take the oral study medication (TS-1)
• no clinically significant abnormal ECG findings within 28 days (4 weeks) prior to registration
• voluntarily signed the written informed consent form

Exclusion Criteria:

• pulmonary fibrosis or interstitial pneumonitis diagnosed within 28 days prior to registration
• presence of diarrhea ≥ CTCAE v.4.03 grade 2
• concomitant active infection or significant co-morbid medical conditions
• moderate or severe ascites or pleural effusion that requires drainage
• central nervous system metastasis
• prior or concurrent malignancies within the last 3 years
• concomitant treatment with flucytosine, phenytoin or warfarin
• pregnant women or nursing mothers, or positive pregnancy test
• severe mental disorder
• judged ineligible by physician for participation in the study due to safety concern