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

Phase 1

Terminated

• Conditions: Metastatic Pancreatic Cancer
• Interventions: Drug: S-1-CCRT

• Registration Number: NCT01946646
• Lead Sponsor: National Taiwan University Hospital

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.

Detailed Description

Not available

Study Timeline

• Study First Submitted: 2013-09-11
• Study First Submitted QC: 2013-09-16
• Study First Posted: 2013-09-19
• Study Start: 2013-10
• Status Verified: 2017-01
• Primary Completion: 2017-01
• Study Completion: 2017-01
• Last Update Submitted: 2017-01-15
• Last Update Posted: 2017-01-18

Recruitment & Eligibility

• Status: TERMINATED
• Sex: All
• Target Recruitment: 10

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 & Design

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Arm && Interventions

Group	Intervention	Description
S-1-CCRT	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

Primary Outcome Measures

Name	Time	Method
maximum-tolerated dose	6 weeks
maximum tolerated dose	6 weeks	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.

Trial Locations

Locations (1)

National Taiwan University Hospital; 🇨🇳 Taipei, Taiwan