Clinical trial · Interventional
Gemcitabine Hydrochloride in Treating Patients With Pancreatic Cancer That Has Been Removed by Surgery
Pharmacogenetics of Gemcitabine: Study of the Impact of Genetic Polymorphism of Cytidine Deaminase (CDA) on Toxicity in Resected Pancreatic Adenocarcinomas
- 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)
RATIONALE: Studying samples of blood from patients with cancer in the laboratory may help doctors learn more about changes that occur in DNA and identify biomarkers related to cancer. It may also help doctors predict how patients will respond to treatment. PURPOSE: This clinical trial is studying gemcitabine hydrochloride in treating patients with pancreatic cancer that has been removed by surgery.
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 (1)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| gemcitabine hydrochloride | Drug | Gemcitabine | ALIAS |
Design
Arms and outcomes
Arms (1)
- type
- OTHER
- label
- gemcitabine
- description
- gemcitabine
- interventionNames
- Drug: gemcitabine hydrochloride
Primary outcomes (1)
- measure
- capability of CDA to predict the occurrence of early severe hematological toxicity upon gemcitabine
- timeFrame
- 2 months
Secondary outcomes (1)
- measure
- Overall Survival
- timeFrame
- 2 years
Eligibility
Eligibility (as posted)
- Sex
- All
- Minimum age
- 18 Years
- Maximum age
- 120 Years
Show eligibility criteria text
DISEASE CHARACTERISTICS: * Histologically confirmed adenocarcinoma of the pancreas * No metastatic or locally advanced (nonresectable) disease * Must have undergone curative surgical resection * Must have macroscopically complete (R0 or R1) surgical outcome * Adjuvant treatment with gemcitabine hydrochloride (for 6 months) is necessary, and able to start treatment within 8 weeks of surgical resection * No ampullomas or endocrine carcinomas PATIENT CHARACTERISTICS: * WHO performance status 0-2 * Neutrophil count ≥ 1,500/mm³ * Platelet count ≥ 100,000/mm³ * Alkaline phosphatases ≤ 5 times upper limit of normal * Total bilirubin ≤ 50 µmol/L * Creatinine clearance ≥ 60 mL/min * Not pregnant or nursing * Able to start adjuvant chemotherapy within 8 weeks of surgery * No evolving infectious syndrome (fever \> 38°C or abscess) * No contraindication for gemcitabine hydrochloride * No prior malignant tumor except for cutaneous basocellular carcinoma or in situ cervical epithelioma (prior history of malignant tumor diagnosed and treated more than 10 years ago allowed, except for breast cancer and melanoma) PRIOR CONCURRENT THERAPY: * See Disease Characteristics * No chemotherapy or radiotherapy within the past 10 years * No prior ablation surgery leaving macroscopic tumor residues (R2)
References
Publications (1)
- RESULTSerdjebi C, Gagniere J, Desrame J, Fein F, Guimbaud R, Francois E, Andre T, Seitz JF, Monterymard C, Arsene D, Volet J, Abakar-Mahamat A, Lecomte T, Guerin-Meyer V, Legoux JL, Deplanque G, Guillet P, Ciccolini J, Lepage C, Dahan L. FFCD-1004 Clinical Trial: Impact of Cytidine Deaminase Activity on Clinical Outcome in Gemcitabine-Monotherapy Treated Patients. PLoS One. 2015 Aug 26;10(8):e0135907. doi: 10.1371/journal.pone.0135907. eCollection 2015. PMID 26308942