Phase I Study Of TS-1 With Concurrent Radiotherapy To Treat Pancreatic Cancer

Study Overview

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

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.

N/A

Metastatic Pancreatic Cancer

DRUG: S-1-CCRT

201211048MPC

Study Record Dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Registration Dates	Results Reporting Dates	Study Record Updates
First Submitted 2013-09-11	Results First Submitted N/A	Last Update Submitted that met QC Criteria 2017-01-15
First Submitted that Met QC Criteria 2013-09-16	Results First Submitted that Met QC Criteria N/A	Last Update Posted (ESTIMATED) 2017-01-18
First Posted (ESTIMATED) 2013-09-19	Results First Posted N/A	Last Verified 2017-01

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

Design Details

Primary Purpose:
Treatment

Allocation:
Na

Interventional Model:
Single Group

Masking:
None

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 Lev	DRUG: S-1-CCRT

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 Lev

DRUG: S-1-CCRT

Primary Outcome Measures	Measure Description	Time Frame
maximum tolerated dose	Dose-limiting toxicities (DLT) are defined as the following manifestations of toxicity observed until completion of CCRT: 1. grade 3 leucopenia and/or neutropenia with a fever ≥ 38°C lasting 3 days or more 2. grade 3 leucopenia and/or neutropenia with infection 3. grade 4 leucopenia and/or neutropenia lasting 3 days or more 4. grade 4 leucopenia and/or neutropenia requiring G-CSF 5. platelet < 25,000/mm3 6. , grade 3 thrombocytopenia requiring transfusion 7. 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

Secondary Outcome Measures	Measure Description	Time Frame

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person’s general health condition or prior treatments.

Ages Eligible for Study:
ALL

Sexes Eligible for Study:
20 Years

Accepts Healthy Volunteers:

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

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

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

TTY Biopharm

Investigators

Publications

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

No publications available

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Resources

PatientS

Caregivers

Clinical Trial Record