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

Metastatic Pancreatic Cancer Clinical Trial

— SR-GS  

Official title:

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

Clinical Trial Details — Status: Terminated

Administrative data

• NCT number: NCT01946646
• Other study ID #: 201211048MPC
• Status: Terminated
• Phase: Phase 1
• First received: September 11, 2013
• Last updated: January 15, 2017
• Start date: October 2013
• Est. completion date: January 2017

Study information

• Verified date: January 2017
• Source: National Taiwan University Hospital
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Terminated
• Enrollment: 10
• Est. completion date: January 2017
• Est. primary completion date: January 2017
• Accepts healthy volunteers: No
• Gender: All
• Age group: 20 Years to 79 Years

Eligibility

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

Related Conditions & MeSH terms

• Metastatic Pancreatic Cancer
• Pancreatic Neoplasms

Intervention

Drug:
• S-1-CCRT

Locations

Country	Name	City	State
Taiwan	National Taiwan University Hospital	Taipei

Sponsors (2)

Lead Sponsor	Collaborator
National Taiwan University Hospital	TTY Biopharm

Country where clinical trial is conducted

Taiwan, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	maximum tolerated dose	Dose-limiting toxicities (DLT) are defined as the following manifestations of toxicity observed until completion of CCRT: grade 3 leucopenia and/or neutropenia with a fever = 38°C lasting 3 days or more; grade 3 leucopenia and/or neutropenia with infection; grade 4 leucopenia and/or neutropenia lasting 3 days or more; grade 4 leucopenia and/or neutropenia requiring G-CSF; platelet < 25,000/mm3; , grade 3 thrombocytopenia requiring transfusion; hemoglobin < 8.0 g/dL; g. serum AST/ALT = 10 times ULN h. total bilirubin = 3 times ULN i. creatinine >3.0 - 6.0 times ULN (grade 3) i. grade 3 or 4 nonhematological toxicities including nausea, vomiting, anorexia, fatigue, constipation, hyperglycemia, and abnormality of sodium, potassium, and calcium If three or more patients experience DLT at a given dose level, then the previous dose level will be considered as the MTD.	6 weeks
Primary	maximum-tolerated dose		6 weeks