This trial is active, not recruiting.

Condition pancreatic cancer
Treatments drug: gemcitabine, s-1, gemcitabine, s-1, radiotherapy
Phase phase 2
Sponsor Osaka Medical Center for Cancer and Cardiovascular Diseases
Start date April 2009
End date December 2012
Trial size 110 participants
Trial identifier NCT01430052, TatsuyaIoka, UMIN000001990


The purpose of this study is to evaluate the clinical effectiveness of Gemcitabine/S-1 combination chemoradiotherapy with Gemcitabine /S-1 combination chemotherapy for unresectable locally advanced pancreatic cancer.

United States No locations recruiting
Other countries No locations recruiting

Study Design

Allocation randomized
Endpoint classification safety/efficacy study
Intervention model parallel assignment
Masking open label
Primary purpose treatment
Gemcitabine 1000mg/m2 on Day 1 and 8, every 3 weeks. S-1 60-100mg/day on Day 1 to 14, every 3 weeks
drug: gemcitabine, s-1 gemzer
Gemcitabine 1,000mg/㎡ is administered with 30 min intravenous infusion on day 1 and 8 every 3 weeks. S-1 60mg/㎡/day is administered orally for 2 consecutive weeks every 3 weeks.
Gemcitabine 600mg/m2 on Day 1 and 8, every 3 weeks. S-1 60-100mg/day on Day 1 to 14, every 3 weeks with radiotherapy 50.4Gy in 28 fractions
gemcitabine, s-1, radiotherapy gemzer
Gemcitabine 600mg/㎡ is administered with 30 min intravenous infusion on day 1 and 8 every 3 weeks. S-1 60mg/㎡/day is administered orally for 2 consecutive weeks every 3 weeks. Concurrent radiotherapy (a total dose of 50.4Gy) was delivered in 28 fractions.

Primary Outcomes

Two year survival rate
time frame: 2 years

Secondary Outcomes

Progression free survival(PFS)
time frame: 4 years
Overall Survival (OS)
time frame: 4 years
Adverse events
time frame: 4 years
Response rate
time frame: 4 years

Eligibility Criteria

Male or female participants from 20 years up to 80 years old.

Inclusion Criteria: 1. Histologically or cytologically confirmed adenocarcinoma, adenocarcinoma squamous carcinoma of pancreatic cancer. 2. Patients who confirmed unresectable locally advanced pancreatic cancer with the criteria below. - Involving over 1/2 circumference of major artery (SMA/CA). (Under 1/2 that was borderline lesion.) - Involving over the merging section of portal-SMV. - No distal metastasis with diagnostic imaging. - Confirmed by CT image performed with in four weeks before registration. 3. Performance Status:0-1(ECOG) 4. Patients of age =>20 and 80> 5. sufficient organ functions - neutrophils>=1,500/mm3 - platelets>=100,000/mm3 - hemoglobin>=9.0g/dl - AST(GOT)/ALT(GPT) <=150IU - total bilirubin <=2.0mg/dl, (or <=3.0mg/dl if biliary drainage were present) - serum creatinine <= 1.2mg/dl - creatinine clearance>=60ml/min 6. Life expectancy more than 3 months. 7. Written informed consent. Exclusion Criteria: 1. Lung fibrosis or intestinal pneumonia, and anamnesis or imaging findings. 2. Watery diarrhea 3. Severe infection 4. Severe complication (heart failure, renal failure, hepatic insufficiency,hemorrhagic peptic ulcer, intestines paralysis,ileus or uncontrolled diabetes etc) 5. Massive pleural or abdominal effusion. 6. Metastasis to central nervous system. 7. Active synchronous or metachronous malignancy other than carcinoma in situ. 8. Regular use of flucytosine, fenitoin or warfarin 9. Pregnant or lactation women, or women with known or suspected pregnancy and men who want let to pregnancy 10. Severe mental illness 11. Patients who are judged inappropriate for the entry into the study by the investigator.

Additional Information

Official title Randomized Phase II Study Comparing Gemcitabine/S-1 Combination Chemoradiotherapy With Gemcitabine/S-1 Combination Chemotherapy for Unresectable Locally Advanced Pancreatic Cancer.
Description When cancer develops outside of the pancreas from within the anatomical placement of the pancreas itself, it becomes difficult to excise in most cases. Generally, most pancreatic cancers are already unresectable at the time of diagnosis when we have recognized infiltration of over 1/2 the circumference of major arteries such as the celiac artery and super mesenteric artery in particular. In comparison with advanced pancreatic cancer with distant metastases, it is not easy to treat unresectable locally advanced pancreatic cancer, even when performing standard gemcitabine monotherapy. In the case of unresectable locally advanced pancreatic cancers without distant metastases, we are left with the choice of whether or not to perform radiation therapy. This decision remains unsolved worldwide, despite the continuing efforts of researchers to bring an end to the clinical doubt. We will report our results as well as the problems of combining treatments with chemoradiotherapy, using the novel anticancer agent gemcitabine as well as/or S-1, not 5FU, predominantly from our own clinical trials on this occasion.
Trial information was received from ClinicalTrials.gov and was last updated in April 2015.
Information provided to ClinicalTrials.gov by Osaka Medical Center for Cancer and Cardiovascular Diseases.