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Study of Neoadjuvent Chemotherapy Followed by SBRT in Patients With Resectable and Borderline Resectable Pancreatic Cancer

Primary Purpose

Pancreatic Cancer, Pancreatic Adenocarcinoma

Status

Withdrawn

Phase

Phase 2

Locations

United States

Study Type

Interventional

Intervention

Stereotactic Body Radiation Therapy (SBRT)

FOLFIRINOX

About this trial

This is an interventional treatment trial for Pancreatic Cancer focused on measuring Folfirinox, Cancer, Radiation Therapy, neoadjuvent chemotherapy, Stereotactic Body Radiation Therapy (SBRT)

Eligibility Criteria

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

Inclusion Criteria:

Age ≥ 18 years
Pathologic confirmation of pancreatic ductal adenocarcinoma
Resectable disease (determined by treating surgeon)
Patients planning to receive neoadjuvant Folfirinox as part of their standard of care treatment
No evidence of distant organ metastatic disease
Eastern Cooperative Oncology Group Performance status 0-1
Ability to understand and the willingness to sign informed consent document
Adequate organ function, defined by the following laboratory values, at the time of study entry:
1. Hemoglobin ≥ 10 g/dL (transfusions acceptable)
2. Absolute Neutrophil Count ≥ 0.5 x 109/L
3. Platelets ≥ 100 x 109/L
4. Creatinine ≤ 1.5x institutional upper limit of normal (ULN) or creatinine clearance ≥ 50 mL/min
5. Total bilirubin ≤ 2x institutional ULN
6. Aspartate aminotransferase test (AST)/ Alanine Aminotransferase Test (ALT) ≤ 3x institutional ULD

Exclusion Criteria:

Severe/uncontrolled intercurrent illness that, in the opinion of the patient's treating physicians, would prevent the patient from receiving either multi agent chemotherapy, high-dose radiation, or undergoing resection of the pancreatic tumor
Prior therapy for PDAC
Prior radiation to the upper abdomen (RT to other sites acceptable)
Inability to undergo port or PICC line placement
Active gastric or duodenal ulcer
Tumor invasion of the intestinal or gastric lumen
Active hepatitis B or other active serious infections
Pregnant and breastfeeding women are excluded. Women of child-bearing potential must have a negative urine or serum pregnancy test and be willing to use acceptable methods of birth control (hormonal or barrier method of birth control; abstinence) to avoid pregnancy for the duration of the study treatment
Life expectancy of < 3 months
Patients with contraindications to either PET scan or MRI (e.g., pacemaker/ICD) will NOT be excluded from study participation. Such patients will be treated per protocol but will not be required to undergo PET-MRI.

Sites / Locations

Indiana University Melvin & Bren Simon Cancer Center

Arms of the Study

Arm 1

Arm Type

Experimental

Arm Label

Preoperative Chemotherapy + SBRT

Arm Description

Participants in this trial will receive neoadjuvant and adjuvant FOLFIRINOX chemotherapy for 6 cycles (1 cycle = 14 days) per routine guidelines. After 6 cycles of neoadjuvant therapy are completed, patients will undergo imaging with pancreatic protocol CT and PET-MRI to assess disease status . Patients without evidence of disease progression at the end of 6 cycles of neoadjuvant treatment will proceed to SBRT followed by surgical resection. Following surgery, patients will receive an additional 6 cycles of FOLFIRINOX chemotherapy.

Outcomes

Primary Outcome Measures

Local control rate among PDAC patients treated with neoadjuvant chemotherapy followed by SBRT

Secondary Outcome Measures

Pathological tumor response grade

Rate of margin negative resection

Rate of progression free survival

Overall survival

Local control rate

Time to development of distant metastases

Site of first failure

Rate of grade 3-4 non hematological toxicity rates

Full Information

NCT ID

NCT04130399

First Posted

October 15, 2019

Last Updated

October 15, 2019

Sponsor

Indiana University

1. Study Identification

Unique Protocol Identification Number

NCT04130399

Brief Title

Study of Neoadjuvent Chemotherapy Followed by SBRT in Patients With Resectable and Borderline Resectable Pancreatic Cancer

Official Title

Study of Neoadjuvent Chemotherapy Followed by SBRT in Patients With Resectable and Borderline Resectable Pancreatic Cancer

Study Type

Interventional

2. Study Status

Record Verification Date

September 2019

Overall Recruitment Status

Withdrawn

Why Stopped

Study is being abandoned.

Study Start Date

July 1, 2019 (Anticipated)

Primary Completion Date

January 1, 2022 (Anticipated)

Study Completion Date

January 1, 2023 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title

Principal Investigator

Name of the Sponsor

Indiana 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.

Data Monitoring Committee

Yes

5. Study Description

Brief Summary

The purpose of this study is to research the effects of delivering full-dose neoadjuvant multi-agent chemotherapy (folfirinox) followed by stereotactic body radiation therapy (SBRT) in patients with resectable pancreatic ductal adenocarcinoma (PDAC) in order to intensify local therapy and improve outcomes.

Detailed Description

Primary Objectives: 1. To assess one-year local control rates in patients with operable PDAC who receive neoadjuvant chemotherapy and SBRT Secondary Objectives: To assess the following disease control endpoints: pathological response, disease-free survival, overall survival, failure pattern (local vs. distant) and time to development of distant metastases To assess safety of the SBRT regimen Exploratory objectives To obtain exploratory data correlating tumor response grade with changes in circulating tumor DNA levels following chemotherapy, SBRT, and surgery in patients with PDAC To obtain exploratory data correlating circulating tumor DNA (ctDNA) changes with disease control endpoints (overall survival, disease-free survival, failure pattern, and time to development of distant metastases) To obtain exploratory data on positron emission tomography (PET) and magnetic resonance imaging (MRI) findings and correlations with tumor response among patients treated on study.

6. Conditions and Keywords

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

Pancreatic Cancer, Pancreatic Adenocarcinoma

Keywords

Folfirinox, Cancer, Radiation Therapy, neoadjuvent chemotherapy, Stereotactic Body Radiation Therapy (SBRT)

7. Study Design

Primary Purpose

Treatment

Study Phase

Phase 2

Interventional Study Model

Single Group Assignment

Model Description

preoperative chemotherapy with FOLFIRINOX followed by SBRT in patients with resectable pancreatic cancer.

Masking

None (Open Label)

Allocation

N/A

Enrollment

0 (Actual)

8. Arms, Groups, and Interventions

Arm Title

Preoperative Chemotherapy + SBRT

Arm Type

Experimental

Arm Description

Intervention Type

Radiation

Intervention Name(s)

Stereotactic Body Radiation Therapy (SBRT)

Intervention Description

Patients will receive 5 fractions of SBRT delivered over a five-day period. Treatment may be delivered over 2 weeks, provided that the patient receives at least 2 fractions per week.

Intervention Type

Drug

Intervention Name(s)

FOLFIRINOX

Intervention Description

Participants in this trial will receive neoadjuvant and adjuvant FOLFIRINOX chemotherapy for 6 cycles (1 cycle = 14 days) per routine guidelines

Primary Outcome Measure Information:

Title

Local control rate among PDAC patients treated with neoadjuvant chemotherapy followed by SBRT

Time Frame

1 year after surgery date

Secondary Outcome Measure Information:

Title

Pathological tumor response grade

Time Frame

Surgery Date (4 weeks [+/- 14 days] from end of SBRT)

Title

Rate of margin negative resection

Time Frame

Surgery Date (4 weeks [+/- 14 days] from end of SBRT)

Title

Rate of progression free survival

Time Frame

From surgery date to first documented date of progression, up to 5 years

Title

Overall survival

Time Frame

From surgery date to date of death, up to 5 years

Title

Local control rate

Time Frame

from date of surgery until date of first documented local failure, up to 5 years

Title

Time to development of distant metastases

Time Frame

From surgery date to date of first documented metastatic disease, up to 5 years

Title

Site of first failure

Time Frame

From surgery date to date of first documented metastatic disease, up to 5 years

Title

Rate of grade 3-4 non hematological toxicity rates

Time Frame

Date of first fraction of SBRT through 30 days (+/-14) after surgery date

10. Eligibility

Sex

All

Minimum Age & Unit of Time

18 Years

Accepts Healthy Volunteers

Eligibility Criteria

Inclusion Criteria: Age ≥ 18 years Pathologic confirmation of pancreatic ductal adenocarcinoma Resectable disease (determined by treating surgeon) Patients planning to receive neoadjuvant Folfirinox as part of their standard of care treatment No evidence of distant organ metastatic disease Eastern Cooperative Oncology Group Performance status 0-1 Ability to understand and the willingness to sign informed consent document Adequate organ function, defined by the following laboratory values, at the time of study entry: Hemoglobin ≥ 10 g/dL (transfusions acceptable) Absolute Neutrophil Count ≥ 0.5 x 109/L Platelets ≥ 100 x 109/L Creatinine ≤ 1.5x institutional upper limit of normal (ULN) or creatinine clearance ≥ 50 mL/min Total bilirubin ≤ 2x institutional ULN Aspartate aminotransferase test (AST)/ Alanine Aminotransferase Test (ALT) ≤ 3x institutional ULD Exclusion Criteria: Severe/uncontrolled intercurrent illness that, in the opinion of the patient's treating physicians, would prevent the patient from receiving either multi agent chemotherapy, high-dose radiation, or undergoing resection of the pancreatic tumor Prior therapy for PDAC Prior radiation to the upper abdomen (RT to other sites acceptable) Inability to undergo port or PICC line placement Active gastric or duodenal ulcer Tumor invasion of the intestinal or gastric lumen Active hepatitis B or other active serious infections Pregnant and breastfeeding women are excluded. Women of child-bearing potential must have a negative urine or serum pregnancy test and be willing to use acceptable methods of birth control (hormonal or barrier method of birth control; abstinence) to avoid pregnancy for the duration of the study treatment Life expectancy of < 3 months Patients with contraindications to either PET scan or MRI (e.g., pacemaker/ICD) will NOT be excluded from study participation. Such patients will be treated per protocol but will not be required to undergo PET-MRI.

Overall Study Officials:

First Name & Middle Initial & Last Name & Degree

Susannah Ellsworth, MD

Organizational Affiliation

Indiana University School of Medicine

Official's Role

Principal Investigator

Facility Information:

Facility Name

Indiana University Melvin & Bren Simon Cancer Center

City

Indianapolis

State/Province

Indiana

ZIP/Postal Code

46202

Country

United States

12. IPD Sharing Statement

Learn more about this trial

Study of Neoadjuvent Chemotherapy Followed by SBRT in Patients With Resectable and Borderline Resectable Pancreatic Cancer

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