Clinical trial · Interventional
Gemcitabine/Cisplatin for Resected Pancreas Cancer: Establishing the Role of ERCC1 in Treatment Decision
Gemcitabine/Cisplatin for Resected Pancreas Cancer: Establishing the Role of Excision Repair Cross Complementation Gene 1 (ERCC1) in Treatment Decision
- Source
- ClinicalTrials.gov
- Retrieved
- Sep 8, 2026
- Layer
- normalized (units and labels harmonized; values unchanged)
- Run
- ING-CLINICALTRIALS-20260908-000001
Why stopped (as posted): Slow accrual
Summary
Brief summary (as posted)
The purpose of this study is to investigate if the investigators can use a specific marker in the pancreatic tumor itself to determine which patients will benefit from receiving combination chemotherapy of gemcitabine and cisplatin after undergoing resection of a pancreatic cancer. The investigators will also investigate if there is any benefit to receiving both chemotherapy drugs as opposed to only gemcitabine after undergoing complete resection of the tumor.
Conditions
Conditions (2)
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 |
| Pancreatic Neoplasms | Pancreatic Neoplasm | ONTOLOGY_EXACT | 0.98 |
Interventions
Interventions (2)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| Cisplatin | Drug | Cisplatin | ALIAS |
| Gemcitabine | Drug | Gemcitabine | ALIAS |
Design
Arms and outcomes
Arms (1)
- type
- EXPERIMENTAL
- label
- Gemcitabine / Cisplatin
- description
- Single arm study. All patients will receive gemcitabine and cisplatin as adjuvant therapy.
- interventionNames
- Drug: Gemcitabine
- Drug: Cisplatin
Primary outcomes (1)
- measure
- Recurrence-free Survival as Measured by CT Scan
- timeFrame
- Every 3 months and then every 6 months for 2 more years after resection
- description
- Clinical data were prospectively collected. Staging was performed using 7th American Committee on Cancer criteria. Patients were followed by radiologic evaluation (CT or MRI) and carbohydrate antigen 19-9 (CA19-9) every 3 months for the first 3 years after resection to assess for recurrence. Subsequently, patients underwent imaging every 6 months.
Secondary outcomes (1)
- measure
Eligibility
Eligibility (as posted)
- Sex
- All
- Minimum age
- 18 Years
Show eligibility criteria text
Inclusion Criteria: 1. Adults (≥ 18 years) at the time of signing informed consent form 2. Understand and voluntarily sign informed consent form 3. Able to adhere to study visit schedule and other protocol requirements 4. Eastern Cooperative Oncology Group (ECOG) performance status of ≤ 2 5. Absolute neutrophil count ≥ 1500 / mm³ 6. Platelet count ≥ 100,000 / mm³ 7. Resectable pancreatic adenocarcinoma 8. Pathologic diagnosis of pancreatic adenocarcinoma Exclusion Criteria: 1. Any serious medical condition, laboratory abnormality, or psychiatric illness that would prevent the subject from signing informed consent form 2. A history of renal dysfunction (serum creatinine \> 1.8 mg/dL) 3. Presence of active infection 4. Untreated second malignancy 5. Pregnant or breast feeding females (A urine pregnancy test will be obtained in all women of child-bearing age at initial screening prior to study enrollment and administration of chemotherapy.)
References
Publications (0)
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