Clinical trial · Interventional
Neoadjuvant FOLFIRINOX Regimen in Patients With Non-metastatic Pancrease Cancer
A Prospective Evaluation of Neoadjuvant FOLFIRINOX Regimen in Patients With Non-metastatic Pancreas Cancer (Baylor University Medical Center and Texas Oncology Experience)
NCT01771146CI-TRIAL-00025716unknownN/AClinicalTrials.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)
A prospective evaluation of neoadjuvant FOLFIRINOX regimen in patients with non-metastatic pancreas cancer (Baylor University Medical Center and Texas Oncology Experience)
Conditions
Conditions (3)
Free-text conditions as registered, with the CancerIndex entity they were reconciled to and the match type.
| Condition (as posted) | Mapped entity | Match | Confidence |
|---|---|---|---|
| Localized Pancreas Cancer | Pancreatic Carcinoma | CURATED_BROADER | 0.78 |
| Non-metastatic Pancreas Cancer | Pancreatic Neoplasm | PROBABILISTIC | 0.70 |
| Pancreas Cancer | Pancreatic Carcinoma | ALIAS | 0.90 |
Interventions
Interventions (1)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| FOLFIRINOX Regimen | Drug | — | UNRESOLVED |
Design
Arms and outcomes
Arms (1)
- type
- OTHER
- label
- Neoadjuvant FOLFIRINOX Regimen
- description
- Single arm, treated with neoadjuvant FOLFIRINOX prior to surgical resection
- interventionNames
- Drug: FOLFIRINOX Regimen
Primary outcomes (1)
- measure
- Progression Free Survival (PFS) as defined by the length of time that a patient survives without any signs or symptoms of that cancer or any other type of cancer
- timeFrame
- Up to 5 years
Secondary outcomes (3)
- measure
- • The length of time from diagnosis (enrollment) to death
- timeFrame
- Up to 5 years
- measure
Eligibility
Eligibility (as posted)
- Sex
- All
- Minimum age
- 18 Years
Show eligibility criteria text
Inclusion Criteria: * 18 years of age or older * Male or non-pregnant and non-lactating female * Histologically or cytologically confirmed adenocarcinoma of pancreas * Patients must have satisfactory blood counts and blood chemistry levels at baseline (refer to Appendix 2, Study Laboratory References Range). * Patient has Eastern Cooperative Oncology Group(ECOG) Performance Status 0 to 1 (refer to Appendix 7): * 0 - Asymptomatic (Fully active, able to carry on all predisease activities without restriction) * 1 - Symptomatic but completely ambulatory (Restricted in physically strenuous activity but ambulatory and able to carry out work of a light or sedentary nature. For example, light housework, office work) * Signed study consent form Exclusion Criteria: * \<18 years of age * Pregnant or lactating female * Patient has islet cell neoplasms * Patient has known brain metastases * Patient has metastatic disease * Active secondary malignancies * Active, uncontrolled bacterial, viral, or fungal infection(s) requiring systemic therapy * Known infection with hepatitis B, hepatitis C, or cirrhosis * Major surgery or vascular device placement (excluding ports for IV medication/chemotherapy) within 2 weeks prior to Day 1 of treatment in study * Prior chemotherapy or radiation for pancreatic cancer * History of allergy or hypersensitivity to the study drugs * Patient is enrolled in any outside (outside Baylor University Medical Center or Texas Oncology) clinical protocol or investigational trial * Significant cardiac disease as defined as New York Heart Association (NYHA) classification III or IV, uncontrolled congestive heart failure (CHF), or prior myocardial infarction (MI) last 6-months * Any prior gastrointestinal (GI) disease or history of prior pelvic or abdominal radiation which in the opinion of the investigator may place the patient at increased risk * Peripheral sensory neuropathy ≥ to grade 2 at baseline * Significant co-morbidities deemed by investigator as unsuitable for participation/enrollment * Study consent form not signed
References
Publications (0)
Data not yet available
No reference posted for this study.