Clinical trial · Interventional
GEM vs GEM+TS-1 for Advanced Pancreatic Cancer
Randomized Phase II Study of Gemcitabine (GEM) Versus GEM+TS-1 for Advanced Pancreatic Cancer
NCT00514163CI-TRIAL-00005117completedPhase 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 primary objective of this study is to compare tumor response rate of the test arm(gemcitabine+S-1) with the control arm(gemcitabine alone) in patients with unresectable 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 |
|---|---|---|---|
| gemcitabine | Drug | Gemcitabine | ALIAS |
| gemcitabine + S-1 | Drug | — | UNRESOLVED |
Design
Arms and outcomes
Arms (2)
- type
- EXPERIMENTAL
- label
- 1
- description
- gemcitabine + S-1
- interventionNames
- Drug: gemcitabine + S-1
- type
- ACTIVE_COMPARATOR
- label
- 2
- description
- S-1
- interventionNames
- Drug: gemcitabine
Primary outcomes (1)
- measure
- response rate
- timeFrame
- during observation
Secondary outcomes (4)
Eligibility
Eligibility (as posted)
- Sex
- All
- Minimum age
- 20 Years
- Maximum age
- 75 Years
Show eligibility criteria text
Inclusion Criteria: 1. Histologically or cytologically proven unresectable pancreatic carcinoma 2. There must be measurable lesions with multislice CT 3. ECOG Performance status 0-2 4. No other active cancer 5. No previous therapy such as radiotherapy, chemotherapy and immunotherapy 6. Adequate organ functions are preserved as WBC more than 4000/mm3,Hb more than 8.0g/dl,neutrophil more than 2000/mm3,platlet more than 100,000/mm3, AST less than 2.5 x normal or less than 5.0 x normal if the patient had known liver metastasis, bilirubin less than 2.0mg/dl, Ccr more than 60ml/min 7. No serious complications 8. Be able to eat food 9. Life expectancy of more than 8 weeks duration 10. Informed consent is obtained- Exclusion Criteria: 1. Interstitial pneumonia 2. Uncontrollable diabetes, liver dysfunction, angina pectoris,or myocardial infarction with its onset within 3 months 3. Serious infection 4. Pregnant or lactating females 5. History of serious drug allergy 6. Serious other complications 7. Uncontrolled mental disorders -
References
Publications (0)
Data not yet available
No reference posted for this study.