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

Primary Purpose

Pancreatic Cancer

Status

Recruiting

Phase

Phase 2

Locations

United States

Study Type

Interventional

Intervention

mFOLFIRINOX

Stereotactic body radiotherapy (SBRT)

About this trial

This is an interventional treatment trial for Pancreatic Cancer

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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

Sites / Locations

Yale University School of MedicineRecruiting

Arms of the Study

Arm 1

Arm Type

Experimental

Arm Label

mFOLFIRINOX followed by SBRT

Arm Description

Patients will receive mFOLFIRINOX, followed stereotactic body radiotherapy (SBRT).

Outcomes

Primary Outcome Measures

Progression Free Survival

Progression-free survival (PFS) at will be judged by CT scan and Response evaluation criteria in solid tumors (RECIST).

Secondary Outcome Measures

Radiographic Response

Radiographic response to FOLFIRINOX and SBRT will be done by comparing IV contrast CT scans before and after therapy.

Rates of Recurrence

Rates of recurrence (local only, systemic only, and both local and systemic) will be monitored for up to 3 years depending on time when the initiation of treatment begins.

Rates of grade 3 or greater gastrointestinal toxicity

Grade 3 or greater gastrointestinal toxicities will be monitored including acute toxicities occurring within 3 months of treatment, and late toxicities occurring over 3 months after completion of radiation.

Overall Survival

Patients will be monitored for overall survival for up to 3 years depending on time when the initiation of treatment begins.

Full Information

NCT ID

NCT03991962

First Posted

June 18, 2019

Last Updated

March 17, 2023

Sponsor

Yale University

1. Study Identification

Unique Protocol Identification Number

NCT03991962

Brief Title

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

Official Title

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

Study Type

Interventional

2. Study Status

Record Verification Date

March 2023

Overall Recruitment Status

Recruiting

Study Start Date

September 19, 2019 (Actual)

Primary Completion Date

August 2024 (Anticipated)

Study Completion Date

February 2025 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title

Sponsor

Name of the Sponsor

Yale University

4. Oversight

Studies a U.S. FDA-regulated Drug Product

Yes

Studies a U.S. FDA-regulated Device Product

Product Manufactured in and Exported from the U.S.

Yes

Data Monitoring Committee

Yes

5. Study Description

Brief Summary

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.

Detailed Description

The Primary and Secondary are listed below. Primary Objective: - To evaluate progression free survival after modified FOLFIRINOX and SBRT in borderline resectable and locally advanced pancreatic cancer. Secondary Objective: To evaluate the radiographic response to FOLFIRINOX and SBRT by comparing IV contrast CT scans before and after therapy. To determine rates of recurrence (local only, systemic only, and both local and systemic), and overall survival. To determine rates of grade 3 or greater gastrointestinal toxicity, including acute toxicities occurring within 3 months of treatment, and late toxicities occurring over 3 months after completion of radiation.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study

Pancreatic Cancer

7. Study Design

Primary Purpose

Treatment

Study Phase

Phase 2

Interventional Study Model

Single Group Assignment

Model Description

Open label, single group design

Masking

None (Open Label)

Allocation

N/A

Enrollment

28 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title

mFOLFIRINOX followed by SBRT

Arm Type

Experimental

Arm Description

Patients will receive mFOLFIRINOX, followed stereotactic body radiotherapy (SBRT).

Intervention Type

Drug

Intervention Name(s)

mFOLFIRINOX

Intervention Description

Patients will receive 6-12 cycles of mFOLFIRINOX every 2 weeks

Intervention Type

Radiation

Intervention Name(s)

Stereotactic body radiotherapy (SBRT)

Intervention Description

Stereotactic body radiotherapy (SBRT) will be delivered to the primary tumor and any adjacent involved lymph nodes to 33 Gy in 5 fractions over the course of 2 weeks, and within 4 weeks of chemotherapy.

Primary Outcome Measure Information:

Title

Progression Free Survival

Description

Progression-free survival (PFS) at will be judged by CT scan and Response evaluation criteria in solid tumors (RECIST).

Time Frame

9 months

Secondary Outcome Measure Information:

Title

Radiographic Response

Description

Radiographic response to FOLFIRINOX and SBRT will be done by comparing IV contrast CT scans before and after therapy.

Time Frame

Within 21 days of starting study drug

Title

Rates of Recurrence

Description

Rates of recurrence (local only, systemic only, and both local and systemic) will be monitored for up to 3 years depending on time when the initiation of treatment begins.

Time Frame

Up to 3 years

Title

Rates of grade 3 or greater gastrointestinal toxicity

Description

Time Frame

Up to 3 months post treatment

Title

Overall Survival

Description

Patients will be monitored for overall survival for up to 3 years depending on time when the initiation of treatment begins.

Time Frame

Up to 3 years

10. Eligibility

Sex

All

Minimum Age & Unit of Time

18 Years

Accepts Healthy Volunteers

Eligibility 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

Central Contact Person:

First Name & Middle Initial & Last Name or Official Title & Degree

Kimberly Johung, MD, PhD

Phone

203-737-6876

kimberly.johung@yale.edu

Overall Study Officials:

First Name & Middle Initial & Last Name & Degree

Kimberly Johung, MD, PhD

Organizational Affiliation

Yale University

Official's Role

Principal Investigator

Facility Information:

Facility Name

Yale University School of Medicine

City

New Haven

State/Province

Connecticut

ZIP/Postal Code

06511

Country

United States

Individual Site Status

Recruiting

Facility Contact:

First Name & Middle Initial & Last Name & Degree

Kimberly Johung, MD, PhD

Phone

203-737-6876

kimberly.johung@yale.ed

First Name & Middle Initial & Last Name & Degree

Kwasi Boateng, MS

Phone

203-314-7948

Kwasi.Boateng@yale.edu

First Name & Middle Initial & Last Name & Degree

Kimberly Johung, MD, PhD

12. IPD Sharing Statement

Plan to Share IPD

Learn more about this trial

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

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