Clinical trial · Interventional
Chemoradiotherapy With Gemcitabine/S-1 vs Gemcitabine/S-1 for Locally Advanced Pancreatic Cancer
Randomized Phase II Study Comparing Gemcitabine/S-1 Combination Chemoradiotherapy With Gemcitabine/S-1 Combination Chemotherapy for Unresectable Locally Advanced Pancreatic Cancer.
NCT01430052CI-TRIAL-00030455completedPhase 2ClinicalTrials.gov clinicaltrialsProvenance
- Source
- ClinicalTrials.gov
- Retrieved
- Sep 8, 2026
- Layer
- normalized (units and labels harmonized; values unchanged)
- Run
- ING-CLINICALTRIALS-20260908-000001
Summary
Brief summary (as posted)
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.
Conditions
Conditions (1)
Free-text conditions as registered, with the CancerIndex entity they were reconciled to and the match type.
| Condition (as posted) | Mapped entity | Match | Confidence |
|---|---|---|---|
| Pancreatic Cancer | Malignant Pancreatic Neoplasm | CURATED_EXACT | 0.92 |
Interventions
Interventions (2)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| Drug: gemcitabine, S-1 | Drug | — | UNRESOLVED |
| gemcitabine, S-1, radiotherapy | Drug | — | UNRESOLVED |
Design
Arms and outcomes
Arms (2)
- type
- OTHER
- label
- Gemcitabine , S-1
- description
- Gemcitabine 1000mg/m2 on Day 1 and 8, every 3 weeks. S-1 60-100mg/day on Day 1 to 14, every 3 weeks
- interventionNames
- Drug: Drug: gemcitabine, S-1
- type
- EXPERIMENTAL
- label
- Gemcitabine, S-1, radiotherapy
- description
- 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
- interventionNames
- Drug: gemcitabine, S-1, radiotherapy
Primary outcomes (1)
- measure
- Two year survival rate
- timeFrame
Eligibility
Eligibility (as posted)
- Sex
- All
- Minimum age
- 20 Years
- Maximum age
- 80 Years
Show eligibility criteria text
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.
References
Publications (0)
Data not yet available
No reference posted for this study.