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

Primary Purpose

Metastatic Pancreatic Cancer

Status
Terminated
Phase
Phase 1
Locations
Taiwan
Study Type
Interventional
Intervention
S-1-CCRT
Sponsored by
National Taiwan University Hospital
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Metastatic Pancreatic Cancer

Eligibility Criteria

20 Years - 79 Years (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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

Sites / Locations

  • National Taiwan University Hospital

Arms of the Study

Arm 1

Arm Type

Experimental

Arm Label

S-1-CCRT

Arm Description

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

Outcomes

Primary Outcome Measures

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.
maximum-tolerated dose

Secondary Outcome Measures

Full Information

First Posted
September 11, 2013
Last Updated
January 15, 2017
Sponsor
National Taiwan University Hospital
Collaborators
TTY Biopharm
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1. Study Identification

Unique Protocol Identification Number
NCT01946646
Brief Title
Phase I Study of TS-1 With Concurrent Radiotherapy to Treat Pancreatic Cancer
Acronym
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)
Study Type
Interventional

2. Study Status

Record Verification Date
January 2017
Overall Recruitment Status
Terminated
Why Stopped
slow recruitment
Study Start Date
October 2013 (undefined)
Primary Completion Date
January 2017 (Actual)
Study Completion Date
January 2017 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
National Taiwan University Hospital
Collaborators
TTY Biopharm

4. Oversight

Data Monitoring Committee
No

5. Study Description

Brief 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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Metastatic Pancreatic Cancer

7. Study Design

Primary Purpose
Treatment
Study Phase
Phase 1
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
N/A
Enrollment
10 (Actual)

8. Arms, Groups, and Interventions

Arm Title
S-1-CCRT
Arm Type
Experimental
Arm Description
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
Intervention Type
Drug
Intervention Name(s)
S-1-CCRT
Primary Outcome Measure Information:
Title
maximum tolerated dose
Description
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.
Time Frame
6 weeks
Title
maximum-tolerated dose
Time Frame
6 weeks

10. Eligibility

Sex
All
Minimum Age & Unit of Time
20 Years
Maximum Age & Unit of Time
79 Years
Accepts Healthy Volunteers
No
Eligibility 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
Facility Information:
Facility Name
National Taiwan University Hospital
City
Taipei
ZIP/Postal Code
100
Country
Taiwan

12. IPD Sharing Statement

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

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