Clinical trial · Interventional
Phase II Study of Chemo-Radiotherapy in Patients With Resectable and Borderline Resectable Pancreatic Cancer
A Neoadjuvant Phase II Study of Chemo-Radiotherapy in Patients With Resectable and Borderline Resectable Pancreatic Cancer
NCT02243358CI-TRIAL-00070865completedPhase 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)
To evaluate the safety and effectiveness of a novel neoadjuvant treatment strategy incorporating 5-fluorouracil/leucovorin with oxaliplatin ( FOLFOX )chemotherapy in combination with chemo-radiation with gemcitabine.
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 |
|---|---|---|---|
| Pancreas Neoplasm Malignant Resectable | Pancreatic Neoplasm | ONTOLOGY_EXACT | 0.90 |
Interventions
Interventions (4)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| Folfox6 | Drug | FOLFOX-6 Regimen | ALIAS |
| Gemcitabine | Drug | Gemcitabine | ALIAS |
| Pancreaticoduodenectomy with retroperitoneal lymphadenectomy | Procedure | — | UNRESOLVED |
| Radiation Therapy | Radiation | — | UNRESOLVED |
Design
Arms and outcomes
Arms (1)
- type
- EXPERIMENTAL
- label
- Neoadjuvant Chemo-Radiotherapy and Resection
- description
- 2 cycles - FOLFOX6 (1 month) Gemcitabine/RT (5-6 weeks) Rest period 2 weeks Re-staging evaluation (CT scan to be done during the 2 weeks of rest) Surgery (To be performed no later than 6 weeks after completion of chemo-radiation)
- interventionNames
- Drug: Folfox6
- Drug: Gemcitabine
- Radiation: Radiation Therapy
- Procedure: Pancreaticoduodenectomy with retroperitoneal lymphadenectomy
Primary outcomes (1)
- measure
- Frequency of R0 Resection
- timeFrame
- 6 weeks
- description
- Evaluate frequency of achieving R0 resection in patients with resectable and borderline resectable pancreatic cancer treated with a neoadjuvant regimen of FOLFOX followed by RT concurrent with gemcitabine chemotherapy at standard dosing
Eligibility
Eligibility (as posted)
- Sex
- All
- Minimum age
- 18 Years
- Maximum age
- 99 Years
Show eligibility criteria text
Inclusion Criteria: * Patients must have histologically or cytologically confirmed pancreatic adenocarcinoma of the pancreatic head or body * Patients must have radiographically-confirmed surgically resectable or borderline resectable disease at study entry staged at T1-3, NO-1 and MO * Age \>/= 18years * Life expectancy of greater than 6 months in the opinion of the investigator, excluding theh pancreatic cancer * Eastern Cooperative Oncology Group (ECOG) performance status \</= 1 * Required laboratory data (see protocol) * Disease assessment by CT scan within 4 weeks of study entry * Ability to understand and the willingness to sign a written informed consent document Exclusion Criteria: * Patients may not be receiving any other investigational agent * Patients with metastatic disease are excluded from this clinical trial * History of allergic reactions attributed to Fluorouracil (5FU), oxaliplatin and gemcitabine * No prior chemotherapy or radiation therapy for pancreatic cancer (previous chemotherapy or radiation therapy for other malignancies is permitted) * Patients with uncontrolled hypocalcemia, hypomagnesemia, hyponatremia, hypophosphatemia or hypokalemia defined as less than the lower limit of normal for the institution, despite adequate electrolyte supplementation are excluded from this study. * Uncontrolled serious intercurrent illness including, but not limited to, ongoing or serious active infection requiring IV antibiotics for over 30 days, symptomatic congestive heart failure, unstable angina pectoris, cardiac arrhythmia other than chronic, stable atrial fibrillation, or psychiatric illness/social situations that would limit compliance with study requirements * Pregnant or breastfeeding women are excluded from this study. * Known HIV-positive patients are ineligible * Patients with unresectable disease are excluded form the protocol (see Appendix B for National Comprehensive cancer Network \[NCCN\] criteria for determining resectability status). Surgical resectability must be confirmed by a surgeon experienced in pancreatic surgery. * Patients with pancreatic tail lesions will be excluded
References
Publications (1)
- RESULTThanikachalam K, Damarla V, Seixas T, Dobrosotskaya I, Wollner I, Kwon D, Winters K, Raoufi M, Li J, Siddiqui F, Khan G. Neoadjuvant Phase II Trial of Chemoradiotherapy in Patients With Resectable and Borderline Resectable Pancreatic Cancer. Am J Clin Oncol. 2020 Jun;43(6):435-441. doi: 10.1097/COC.0000000000000688. PMID 32251119