Working…
ClinicalTrials.gov
ClinicalTrials.gov Menu

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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT04130399
Recruitment Status : Withdrawn (Study is being abandoned.)
First Posted : October 17, 2019
Last Update Posted : October 17, 2019
Sponsor:
Information provided by (Responsible Party):
Susannah Ellsworth, Indiana University

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.

Condition or disease Intervention/treatment Phase
Pancreatic Cancer Pancreatic Adenocarcinoma Radiation: Stereotactic Body Radiation Therapy (SBRT) Drug: FOLFIRINOX Phase 2

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.

Layout table for study information
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)
Primary Purpose: Treatment
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

Resource links provided by the National Library of Medicine


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 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.

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




Primary Outcome Measures :
  1. Local control rate among PDAC patients treated with neoadjuvant chemotherapy followed by SBRT [ Time Frame: 1 year after surgery date ]

Secondary Outcome Measures :
  1. Pathological tumor response grade [ Time Frame: Surgery Date (4 weeks [+/- 14 days] from end of SBRT) ]
  2. Rate of margin negative resection [ Time Frame: Surgery Date (4 weeks [+/- 14 days] from end of SBRT) ]
  3. Rate of progression free survival [ Time Frame: From surgery date to first documented date of progression, up to 5 years ]
  4. Overall survival [ Time Frame: From surgery date to date of death, up to 5 years ]
  5. Local control rate [ Time Frame: from date of surgery until date of first documented local failure, up to 5 years ]
  6. Time to development of distant metastases [ Time Frame: From surgery date to date of first documented metastatic disease, up to 5 years ]
  7. Site of first failure [ Time Frame: From surgery date to date of first documented metastatic disease, up to 5 years ]
  8. Rate of grade 3-4 non hematological toxicity rates [ Time Frame: Date of first fraction of SBRT through 30 days (+/-14) after surgery date ]


Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.


Layout table for eligibility information
Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
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.

Information from the National Library of Medicine

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


Locations
Layout table for location information
United States, Indiana
Indiana University Melvin & Bren Simon Cancer Center
Indianapolis, Indiana, United States, 46202
Sponsors and Collaborators
Indiana University
Investigators
Layout table for investigator information
Principal Investigator: Susannah Ellsworth, MD Indiana University School of Medicine

Layout table for additonal information
Responsible Party: Susannah Ellsworth, Assistant Professor of Radiation Oncology, Indiana University
ClinicalTrials.gov Identifier: NCT04130399     History of Changes
Other Study ID Numbers: IUSCC-0686
First Posted: October 17, 2019    Key Record Dates
Last Update Posted: October 17, 2019
Last Verified: September 2019

Layout table for additional information
Studies a U.S. FDA-regulated Drug Product: Yes
Studies a U.S. FDA-regulated Device Product: No
Product Manufactured in and Exported from the U.S.: No
Keywords provided by Susannah Ellsworth, Indiana University:
Folfirinox
Cancer
Radiation Therapy
neoadjuvent chemotherapy
Stereotactic Body Radiation Therapy (SBRT)
Additional relevant MeSH terms:
Layout table for MeSH terms
Adenocarcinoma
Pancreatic Neoplasms
Carcinoma
Neoplasms, Glandular and Epithelial
Neoplasms by Histologic Type
Neoplasms
Digestive System Neoplasms
Neoplasms by Site
Endocrine Gland Neoplasms
Digestive System Diseases
Pancreatic Diseases
Endocrine System Diseases