Phase I Study of TS-1 With Concurrent Radiotherapy to Treat Pancreatic Cancer (SR-GS)

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.

Study Overview

• Status: Terminated
• Conditions: Metastatic Pancreatic Cancer
• Intervention / Treatment: Drug: S-1-CCRT

• Study Type: Interventional
• Enrollment (Actual): 10
• Phase: Phase 1

Contacts and Locations

Study Locations

• Taiwan
  • Taipei, Taiwan, 100
    • National Taiwan University Hospital

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 20 years to 79 years (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: N/A
• Interventional Model: Single Group Assignment
• Masking: None (Open Label)

Number of Arms

1

Arms and Interventions

Participant Group / Arm

Intervention / Treatment

Experimental: S-1-CCRT; There are five dose levels and one arm only. Level 1: S-1, 25 mg/m2, bid, Day 1-14; RT 25 Gy/10 fx, Day 1-5, 8-12 Level 2: S-1, 25 mg/m2, bid, Day 1-14; RT 30 Gy/10 fx, Day 1-5, 8-12 Level 3: S-1, 30 mg/m2, bid, Day 1-14; RT 30 Gy/10 fx, Day 1-5, 8-12 Level 4: S-1, 30 mg/m2, bid, Day 1-16; RT 36 Gy/12 fx, Day 1-5, 8-12, 15-16 Level 5: S-1, 35 mg/m2, bid, Day 1-16; RT 36 Gy/12 fx, Day 1-5, 8-12, 15-16 All dose levels are followed by Gemcitabine/S-1 (G 1000 mg/m2, iv, D1 and 15 plus S-1 60/80/100 mg/day based on BSA, po, D1-7, D15-21, q4w) after the CCRT

Drug: S-1-CCRT

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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
maximum-tolerated dose		6 weeks

Collaborators and Investigators

• Sponsor: National Taiwan University Hospital
• Collaborators: TTY Biopharm

Study record dates

Study Major Dates

• Study Start: October 1, 2013
• Primary Completion (Actual): January 1, 2017
• Study Completion (Actual): January 1, 2017

Study Registration Dates

• First Submitted: September 11, 2013
• First Submitted That Met QC Criteria: September 16, 2013
• First Posted (Estimate): September 19, 2013

Study Record Updates

• Last Update Posted (Estimate): January 18, 2017
• Last Update Submitted That Met QC Criteria: January 15, 2017
• Last Verified: January 1, 2017

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Digestive System Diseases; Neoplasms; Neoplasms by Site; Endocrine System Diseases; Digestive System Neoplasms; Endocrine Gland Neoplasms; Pancreatic Diseases; Pancreatic Neoplasms
• Other Study ID Numbers: 201211048MPC