Phase I Study of TS-1 With Concurrent Radiotherapy to Treat Pancreatic Cancer
Conditions
Metastatic Pancreatic Cancer
Conditions: official terms
Pancreatic Neoplasms
Study Type
Interventional
Study Phase
Phase 1
Study Design
Endpoint Classification: Safety Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment
Intervention
Name: S-1-CCRT
Type: Drug
Overall Status
Recruiting
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.
Criteria for eligibility
Healthy Volunteers: No
Maximum Age: 79 Years
Minimum Age: 20 Years
Gender: Both
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
Location
National Taiwan University Hospital
Taipei, Taiwan
Status: Recruiting
Contact: Shih-Hung Yang, MD - 886-2-23123456 - b4401064@yahoo.com.tw
Start Date
October 2013
Sponsors
National Taiwan University Hospital
Source
National Taiwan University Hospital
Record processing date
ClinicalTrials.gov processed this data on July 28, 2015
ClinicalTrials.gov page