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

Pancreatic Cancer Clinical Trial

Official title:

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

Clinical Trial Details — Status: Withdrawn

Administrative data

• NCT number: NCT04130399
• Other study ID #: IUSCC-0686
• Status: Withdrawn
• Phase: Phase 2
• Start date: July 1, 2019
• Est. completion date: January 1, 2023

Study information

• Verified date: September 2019
• Source: Indiana University
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Withdrawn
• Enrollment: 0
• Est. completion date: January 1, 2023
• Est. primary completion date: January 1, 2022
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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.

Related Conditions & MeSH terms

• Adenocarcinoma
• Pancreatic Adenocarcinoma
• Pancreatic Cancer
• Pancreatic Neoplasms

Intervention

Radiation:
• 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.

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

Locations

Country	Name	City	State
United States	Indiana University Melvin & Bren Simon Cancer Center	Indianapolis	Indiana

Sponsors (1)

Lead Sponsor	Collaborator
Indiana University

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Local control rate among PDAC patients treated with neoadjuvant chemotherapy followed by SBRT		1 year after surgery date
Secondary	Pathological tumor response grade		Surgery Date (4 weeks [+/- 14 days] from end of SBRT)
Secondary	Rate of margin negative resection		Surgery Date (4 weeks [+/- 14 days] from end of SBRT)
Secondary	Rate of progression free survival		From surgery date to first documented date of progression, up to 5 years
Secondary	Overall survival		From surgery date to date of death, up to 5 years
Secondary	Local control rate		from date of surgery until date of first documented local failure, up to 5 years
Secondary	Time to development of distant metastases		From surgery date to date of first documented metastatic disease, up to 5 years
Secondary	Site of first failure		From surgery date to date of first documented metastatic disease, up to 5 years
Secondary	Rate of grade 3-4 non hematological toxicity rates		Date of first fraction of SBRT through 30 days (+/-14) after surgery date