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

National Taiwan University

Status and phase: Terminated; Phase 1

Conditions: Metastatic Pancreatic Cancer

Treatments: Drug: S-1-CCRT

Study type: Interventional

Funder types: Other; Industry

Identifiers

NCT01946646

201211048MPC

Details and patient eligibility

About

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.

Enrollment: 10 patients

Sex: All

Ages: 20 to 79 years old

Volunteers: No 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

Trial design

Primary purpose: Treatment

Allocation: N/A

Interventional model: Single Group Assignment

Masking: None (Open label)

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10 participants in 1 patient group

S-1-CCRT

Experimental group

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

Treatment:

Drug: S-1-CCRT