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

NCT ID: NCT04130399

Last Updated: 2019-10-17

Basic Information

• Recruitment Status: WITHDRAWN
• Clinical Phase: PHASE2
• Study Classification: INTERVENTIONAL
• Study Start Date: 2019-07-01
• Study Completion Date: 2023-01-01

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:

1. 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

2. To assess safety of the SBRT regimen

Exploratory objectives

1. To obtain exploratory data correlating tumor response grade with changes in circulating tumor DNA levels following chemotherapy, SBRT, and surgery in patients with PDAC

2. 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)

3. 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.

Conditions

Pancreatic Cancer; Pancreatic Adenocarcinoma

Study Design

• Allocation Method: NA
• Intervention Model: SINGLE_GROUP
• Primary Study Purpose: TREATMENT
• Blinding Strategy: NONE

Study Groups

Preoperative Chemotherapy + SBRT

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.

Group Type: EXPERIMENTAL

Stereotactic Body Radiation Therapy (SBRT)

Intervention Type: RADIATION

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.

FOLFIRINOX

Intervention Type: DRUG

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

Interventions

Stereotactic Body Radiation Therapy (SBRT)

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: RADIATION

FOLFIRINOX

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

Intervention Type: DRUG

Eligibility Criteria

Inclusion Criteria

1. Age ≥ 18 years

2. Pathologic confirmation of pancreatic ductal adenocarcinoma

3. Resectable disease (determined by treating surgeon)

4. Patients planning to receive neoadjuvant Folfirinox as part of their standard of care treatment

5. No evidence of distant organ metastatic disease

6. Eastern Cooperative Oncology Group Performance status 0-1

7. Ability to understand and the willingness to sign informed consent document

8. 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

1. 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

2. Prior therapy for PDAC

3. Prior radiation to the upper abdomen (RT to other sites acceptable)

4. Inability to undergo port or PICC line placement

5. Active gastric or duodenal ulcer

6. Tumor invasion of the intestinal or gastric lumen

7. Active hepatitis B or other active serious infections

8. 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

9. Life expectancy of < 3 months

10. 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.

• Minimum Eligible Age: 18 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Indiana University

OTHER

Sponsor Role: lead

Responsible Party

Susannah Ellsworth

Assistant Professor of Radiation Oncology

Responsibility Role: PRINCIPAL_INVESTIGATOR

Principal Investigators

Susannah Ellsworth, MD

Role: PRINCIPAL_INVESTIGATOR

Indiana University School of Medicine

Locations

Indiana University Melvin & Bren Simon Cancer Center

Indianapolis, Indiana, United States

Countries

United States

Other Identifiers

IUSCC-0686

Identifier Type: -

Identifier Source: org_study_id