ACTIVE_NOT_RECRUITING

Phase II Study to Evaluate Modified Folfirinox and Stereotactic Body Radiation Therapy in Non-metastatic Unresectable Pancreatic Adenocarcinoma

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Study Overview

This clinical trial focuses on testing the efficacy of different digital interventions to promote re-engagement in cancer-related long-term follow-up care for adolescent and young adult (AYA) survivors of childhood cancer.

Description

The purpose of this study is to evaluate the efficacy of modified FOLFIRINOX followed by stereotactic body radiotherapy (SBRT) in patients with borderline resectable pancreatic cancer (BRPC) and locally advanced pancreatic cancer (LAPC). The primary hypothesis will be to determine if modified FOLFIRINOX followed by SBRT improves progression free survival (PFS) compared to historical controls treated with gemcitabine-based chemotherapy with or without standard fractionated radiation.

Official Title

Phase II Study to Evaluate Modified Folfirinox and Stereotactic Body Radiation Therapy in Non-metastatic Unresectable Pancreatic Adenocarcinoma

Quick Facts

Study Start:2019-09-24

Study Completion:2027-02

Study Type:Not specified

Phase:Not Applicable

Enrollment:Not specified

Status:ACTIVE_NOT_RECRUITING

Study ID

NCT03991962

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Ages Eligible for Study:18 Years

Sexes Eligible for Study:ALL

Accepts Healthy Volunteers:No

Standard Ages:ADULT, OLDER_ADULT

Inclusion Criteria	Exclusion 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	* Failing to meet any of the Inclusion Criteria

Inclusion Criteria

Exclusion 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

* Failing to meet any of the Inclusion Criteria

Contacts and Locations

Principal Investigator

Kimberly Johung, MD, PhD

PRINCIPAL_INVESTIGATOR

Yale University

Study Locations (Sites)

Yale University School of Medicine

New Haven, Connecticut, 06511

United States

Collaborators and Investigators

Sponsor: Yale University

Kimberly Johung, MD, PhD, PRINCIPAL_INVESTIGATOR, Yale University

Study Record Dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Registration Dates

Study Start Date2019-09-24

Study Completion Date2027-02

Study Record Updates

Study Start Date2019-09-24

Study Completion Date2027-02

Terms related to this study

Additional Relevant MeSH Terms

Pancreatic Cancer