Clinical trial · Interventional
Study of Gemcitabine and Oxaliplatin With Radiation Therapy in Patients With Pancreatic Cancer
A Multi-Institutional Phase II Study of Neoadjuvant Gemcitabine and Oxaliplatin With Radiation Therapy in Patients With Pancreatic Cancer
NCT00456599CI-TRIAL-00020035completedPhase 2Results postedClinicalTrials.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)
This study will examine a sequence of treatments including pre-operative chemotherapy and radiation, surgery and post-operative chemotherapy for resectable 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 (3)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| gemcitabine | Drug | Gemcitabine | ALIAS |
| oxaliplatin | Drug | Oxaliplatin | ALIAS |
| Radiation | Procedure | — | UNRESOLVED |
Design
Arms and outcomes
Arms (1)
- type
- EXPERIMENTAL
- label
- Oxaliplatin & gemcitabine with radiation
- description
- This study will examine a sequence of treatments including pre-operative chemotherapy and radiation, surgery and post-operative chemotherapy for resectable pancreatic cancer.
- interventionNames
- Drug: gemcitabine
- Drug: oxaliplatin
- Procedure: Radiation
Primary outcomes (1)
- measure
- Two-year Disease Free Survival.
- timeFrame
- two years
- description
- The percent of patients alive and disease-free at two years.
Secondary outcomes (2)
- measure
- Time to Treatment Failure
- timeFrame
Eligibility
Eligibility (as posted)
- Sex
- All
- Minimum age
- 18 Years
Show eligibility criteria text
Inclusion Criteria: * Patients must have cytologic or histologic confirmation of carcinoma arising in the pancreas. * Patients must be deemed resectable or borderline resectable based on criteria in section 4.2 prior to registration. * Patients must have an expected life expectancy of at least 12 weeks and a Zubrod performance status of \< 2. * Patients must have adequate organ function defined as follows: absolute neutrophil count of \> 1500/mm3, platelets \> 100,000/mm3, serum Cr \< 1.5 mg/dl, total bilirubin \< 3.0 mg/dl with relief of biliary obstruction if present (PTC tube or endobiliary stent). * Patients must be free of other active systemic malignancy, ongoing infection, including HIV infection, or any other serious uncontrolled, concomitant systemic disorders or psychiatric condition that would interfere with the safe delivery of protocol therapy. * Patients must be aware of the investigational nature of the therapy and provide written informed consent. * Patients must have no history of previous chemotherapy for pancreatic cancer or any abdominal radiation therapy. * Patients must not have used any investigational agent in the month before enrollment into the study. Exclusion Criteria: * Patients with neuroendocrine tumors are excluded. * Patients with preexisting peripheral neuropathy \> grade 2 are ineligible. * Pregnant or nursing women are ineligible and patients of reproductive potential must agree to use an effective contraceptive method during participation in this trial and for 6 months after trial.
References
Publications (1)
- RESULTKim EJ, Ben-Josef E, Herman JM, Bekaii-Saab T, Dawson LA, Griffith KA, Francis IR, Greenson JK, Simeone DM, Lawrence TS, Laheru D, Wolfgang CL, Williams T, Bloomston M, Moore MJ, Wei A, Zalupski MM. A multi-institutional phase 2 study of neoadjuvant gemcitabine and oxaliplatin with radiation therapy in patients with pancreatic cancer. Cancer. 2013 Aug 1;119(15):2692-700. doi: 10.1002/cncr.28117. Epub 2013 May 29. PMID 23720019