2019-07-01
2022-01-01
2023-01-01
0
NCT04130399
Indiana University
Indiana University
INTERVENTIONAL
Study of Neoadjuvent Chemotherapy Followed by SBRT in Patients With Resectable and Borderline Resectable Pancreatic Cancer
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.
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.
These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.
| Study Registration Dates | Results Reporting Dates | Study Record Updates |
|---|---|---|
2019-10-15 | N/A | 2019-10-15 |
2019-10-15 | N/A | 2019-10-17 |
2019-10-17 | N/A | 2019-09 |
This section provides details of the study plan, including how the study is designed and what the study is measuring.
Primary Purpose:
Treatment
Allocation:
Na
Interventional Model:
Single Group
Masking:
None
Arms and Interventions
| Participant Group/Arm | Intervention/Treatment |
|---|---|
| EXPERIMENTAL: 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 | RADIATION: Stereotactic Body Radiation Therapy (SBRT)
DRUG: FOLFIRINOX
|
| Primary Outcome Measures | Measure Description | Time Frame |
|---|---|---|
| Local control rate among PDAC patients treated with neoadjuvant chemotherapy followed by SBRT | 1 year after surgery date |
| Secondary Outcome Measures | Measure Description | Time Frame |
|---|---|---|
| Pathological tumor response grade | Surgery Date (4 weeks [+/- 14 days] from end of SBRT) | |
| Rate of margin negative resection | Surgery Date (4 weeks [+/- 14 days] from end of SBRT) | |
| Rate of progression free survival | From surgery date to first documented date of progression, up to 5 years | |
| Overall survival | From surgery date to date of death, up to 5 years | |
| Local control rate | from date of surgery until date of first documented local failure, up to 5 years | |
| Time to development of distant metastases | From surgery date to date of first documented metastatic disease, up to 5 years | |
| Site of first failure | From surgery date to date of first documented metastatic disease, up to 5 years | |
| Rate of grade 3-4 non hematological toxicity rates | Date of first fraction of SBRT through 30 days (+/-14) after surgery date |
This section provides the contact details for those conducting the study, and information on where this study is being conducted.
Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person’s general health condition or prior treatments.
Ages Eligible for Study:
ALL
Sexes Eligible for Study:
18 Years
Accepts Healthy Volunteers:
This is where you will find people and organizations involved with this study.
The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.
General Publications
No publications available
NPCF was founded on May 29, 2009 and is a 501(c)(3) organization. All donations are tax deductible.
The information and services provided by the National Pancreatic Cancer Foundation are for informational purposes only. The information and services are not intended to be substitutes for professional medical advice, diagnosis or treatment. The National Pancreatic Cancer Foundation does not recommend nor endorse any specific physicians, products or treatments even though they may be mentioned on this site.
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