Study of Neoadjuvent Chemotherapy Followed by SBRT in Patients With Resectable and Borderline Resectable Pancreatic Cancer
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|ClinicalTrials.gov Identifier: NCT04130399|
Recruitment Status : Withdrawn (Study is being abandoned.)
First Posted : October 17, 2019
Last Update Posted : October 17, 2019
|Condition or disease||Intervention/treatment||Phase|
|Pancreatic Cancer Pancreatic Adenocarcinoma||Radiation: Stereotactic Body Radiation Therapy (SBRT) Drug: FOLFIRINOX||Phase 2|
1. To assess one-year local control rates in patients with operable PDAC who receive neoadjuvant chemotherapy and SBRT
- 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
- 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.
|Study Type :||Interventional (Clinical Trial)|
|Actual Enrollment :||0 participants|
|Intervention Model:||Single Group Assignment|
|Intervention Model Description:||preoperative chemotherapy with FOLFIRINOX followed by SBRT in patients with resectable pancreatic cancer.|
|Masking:||None (Open Label)|
|Official Title:||Study of Neoadjuvent Chemotherapy Followed by SBRT in Patients With Resectable and Borderline Resectable Pancreatic Cancer|
|Estimated Study Start Date :||July 1, 2019|
|Estimated Primary Completion Date :||January 1, 2022|
|Estimated Study Completion Date :||January 1, 2023|
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 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.
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.
Participants in this trial will receive neoadjuvant and adjuvant FOLFIRINOX chemotherapy for 6 cycles (1 cycle = 14 days) per routine guidelines
- Local control rate among PDAC patients treated with neoadjuvant chemotherapy followed by SBRT [ Time Frame: 1 year after surgery date ]
- Pathological tumor response grade [ Time Frame: Surgery Date (4 weeks [+/- 14 days] from end of SBRT) ]
- Rate of margin negative resection [ Time Frame: Surgery Date (4 weeks [+/- 14 days] from end of SBRT) ]
- Rate of progression free survival [ Time Frame: From surgery date to first documented date of progression, up to 5 years ]
- Overall survival [ Time Frame: From surgery date to date of death, up to 5 years ]
- Local control rate [ Time Frame: from date of surgery until date of first documented local failure, up to 5 years ]
- Time to development of distant metastases [ Time Frame: From surgery date to date of first documented metastatic disease, up to 5 years ]
- Site of first failure [ Time Frame: From surgery date to date of first documented metastatic disease, up to 5 years ]
- Rate of grade 3-4 non hematological toxicity rates [ Time Frame: Date of first fraction of SBRT through 30 days (+/-14) after surgery date ]
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT04130399
|United States, Indiana|
|Indiana University Melvin & Bren Simon Cancer Center|
|Indianapolis, Indiana, United States, 46202|
|Principal Investigator:||Susannah Ellsworth, MD||Indiana University School of Medicine|