Evaluating a combination of chemotherapy and radiation for advanced pancreatic cancer
Phase II Study to Evaluate Modified Folfirinox and Stereotactic Body Radiation Therapy in Non-metastatic Unresectable Pancreatic Adenocarcinoma
PHASE2 · Yale University · NCT03991962
This study is testing a new combination of chemotherapy and radiation to see if it helps people with advanced pancreatic cancer live longer without their disease getting worse.
Quick facts
| Phase | PHASE2 |
|---|---|
| Study type | Interventional |
| Enrollment | 28 (estimated) |
| Ages | 18 Years and up |
| Sex | All |
| Sponsor | Yale University (other) |
| Drugs / interventions | chemotherapy, radiation |
| Locations | 1 site (New Haven, Connecticut) |
| Trial ID | NCT03991962 on ClinicalTrials.gov |
What this trial studies
This study aims to assess the effectiveness of modified FOLFIRINOX chemotherapy followed by stereotactic body radiation therapy (SBRT) in patients with borderline resectable and locally advanced pancreatic adenocarcinoma. The primary goal is to determine if this treatment regimen improves progression-free survival compared to historical controls who received gemcitabine-based therapies. Secondary objectives include evaluating radiographic responses, recurrence rates, overall survival, and the incidence of significant gastrointestinal toxicities. The study will involve careful monitoring of patients' health and treatment responses through imaging and clinical assessments.
Who should consider this trial
Good fit: Ideal candidates include individuals with histologically confirmed borderline resectable or locally advanced pancreatic adenocarcinoma who have not received prior treatment for their cancer.
Not a fit: Patients with metastatic pancreatic cancer or those who have previously undergone treatment for pancreatic cancer may not benefit from this study.
Why it matters
Potential benefit: If successful, this approach could significantly improve survival outcomes for patients with advanced pancreatic cancer.
How similar studies have performed: Other studies have shown promising results with similar chemotherapy and radiation combinations, suggesting potential for success in this approach.
Eligibility criteria
Show full inclusion / exclusion criteria
Inclusion Criteria: * Histologically confirmed pancreatic adenocarcinoma * Borderline resectable pancreatic adenocarcinoma or locally advanced pancreatic adenocarcinoma * No evidence of extrapancreatic disease on diagnostic imaging * No evidence of invasion into the duodenum or stomach, as determined by EGD/EUS * No prior treatment (chemotherapy, biological therapy, or radiotherapy) for pancreatic cancer * No prior treatment with oxaliplatin, irinotecan, fluorouracil, or capecitabine * ECOG Performance Status of 0-1 * No other malignancy within past five years (exceptions include basal cell carcinoma of the skin, cervical carcinoma in situ, and non-metastatic prostate cancer) * No evidence of second malignancy at the time of study entry * No interstitial pneumonia or extensive and symptomatic interstitial fibrosis of the lung * No \> grade 2 sensory peripheral neuropathy * No uncontrolled seizure disorder, active neurological disease, or known CNS disease * No significant cardiac disease, including the following: unstable angina, New York Heart Association class II-IV congestive heart failure, myocardial infarction within six months prior to study enrollment * Not pregnant and not nursing * No other medical condition or reason that, in the opinion of the investigator, would preclude study participation * Laboratory parameters as follows: * Absolute neutrophil count ≥1,500/uL, * Platelet count ≥75,000/uL, * Hemoglobin ≥9 g,/dL, * Creatinine \<1.5 X ULN or estimated GFR \>30 ml/min, * Bilirubin \<1.5 X ULN, * AST and ALT \<3 X ULN, * Negative pregnancy test in women of childbearing potential * Able to be treated with SBRT only at the Smilow New Haven campus * Able to have fiducials placed in the pancreas Exclusion Criteria: * Failing to meet any of the Inclusion Criteria
Where this trial is running
New Haven, Connecticut
- Yale University School of Medicine — New Haven, Connecticut, United States (RECRUITING)
Study contacts
- Principal investigator: Kimberly Johung, MD, PhD — Yale University
- Study coordinator: Kimberly Johung, MD, PhD
- Email: kimberly.johung@yale.edu
- Phone: 203-737-6876
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.
Conditions: Pancreatic Cancer