Clinical trial · Interventional
Gemcitabine or Gemcitabine and Cisplatin in the Treatment of Advanced Pancreatic Cancer
Gemcitabine vs Gemcitabine + Cisplatin in the Treatment of Advanced Pancreatic Cancer (Stage II III IV)
NCT00813696CI-TRIAL-00001853GIP-1unknownPhase 3ClinicalTrials.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 impact of the addition of cisplatin to gemcitabine in the treatment of patients with inoperable 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 |
|---|---|---|---|
| cisplatin | Drug | Cisplatin | ALIAS |
| gemcitabine | Drug | Gemcitabine | ALIAS |
Design
Arms and outcomes
Arms (2)
- type
- EXPERIMENTAL
- label
- A
- description
- cisplatin + gemcitabine
- interventionNames
- Drug: gemcitabine
- Drug: cisplatin
- type
- ACTIVE_COMPARATOR
- label
- B
- description
- gemcitabine
- interventionNames
- Drug: gemcitabine
Primary outcomes (1)
- measure
- overall survival
- timeFrame
- 9 months
Secondary outcomes (4)
Eligibility
Eligibility (as posted)
- Sex
- All
- Minimum age
- 18 Years
- Maximum age
- 75 Years
Show eligibility criteria text
Inclusion Criteria: * Histologic or cytologic diagnosis pancreatic cancer * inoperable stage II or stage III or IV disease(UICC, 1997) * Age 18 to 75 years * Karnofsky Performance status \> 50 * Signed informed consent Exclusion Criteria: * Previous chemotherapy * Cerebral metastases * Previous malignancies in past 5 years excluding adequately treated basal or spinocellular skin cancers and insitu cervical cancer * Leukocytes \< 4000 or neutrophils \< 2000 or platelets \< 100000 or hemoglobin \< 10 g/dl * Creatinine value \> upper normal limit * GOT or GPT \> 2.5 times upper normal limit or bilirubin \> 1.5 times upper normal limit in absence of hepatic metastases * Congestive heart failure, severe cardiac arrhythmias or coronary ischemic disease * Other concurrent disease that would, in the investigator's opinion, contraindicate the use of the study drugs * Inability to provide informed consent * Inability to comply with follow-up.
References
Publications (1)
- DERIVEDColucci G, Labianca R, Di Costanzo F, Gebbia V, Carteni G, Massidda B, Dapretto E, Manzione L, Piazza E, Sannicolo M, Ciaparrone M, Cavanna L, Giuliani F, Maiello E, Testa A, Pederzoli P, Falconi M, Gallo C, Di Maio M, Perrone F; Gruppo Oncologico Italia Meridionale (GOIM); Gruppo Italiano per lo Studio dei Carcinomi dell'Apparato Digerente (GISCAD); Gruppo Oncologico Italiano di Ricerca Clinica (GOIRC). Randomized phase III trial of gemcitabine plus cisplatin compared with single-agent gemcitabine as first-line treatment of patients with advanced pancreatic cancer: the GIP-1 study. J Clin Oncol. 2010 Apr 1;28(10):1645-51. doi: 10.1200/JCO.2009.25.4433. Epub 2010 Mar 1. PMID 20194854