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Clinical Trial Details — Status: Withdrawn

Administrative data

NCT number NCT04130399
Other study ID # IUSCC-0686
Secondary ID
Status Withdrawn
Phase Phase 2
First received
Last updated
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
Health authority
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Status Withdrawn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.

Study Design


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
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