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

• Status: Terminated
• Trial end date: 2017-01-01
• Target enrollment: 0
• Participant gender: All

Summary

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.

• Phase: Phase 1
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: National Taiwan University Hospital
• Collaborator: TTY Biopharm

Criteria

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