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

NCT04130399 | Withdrawn Phase 2 DMC FDA Drug

• 1 other identifier: IUSCC-0686
• Study Type: interventional
• Target: N/A
• Locations: 1 country
• Sites: 1

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.

Conditions

Pancreatic Cancer; Pancreatic Adenocarcinoma

Keywords

Folfirinox; Cancer; Radiation Therapy; neoadjuvent chemotherapy; Stereotactic Body Radiation Therapy (SBRT)

Outcome Measures

Primary Outcomes (1)

• Local control rate among PDAC patients treated with neoadjuvant chemotherapy followed by SBRT

  1 year after surgery date

Secondary Outcomes (8)

• 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

Study Arms (1)

Preoperative Chemotherapy + SBRT

EXPERIMENTAL

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); Drug: FOLFIRINOX

Interventions

Stereotactic Body Radiation Therapy (SBRT) RADIATION

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.

Preoperative Chemotherapy + SBRT

FOLFIRINOX DRUG

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

Preoperative Chemotherapy + SBRT

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Age ≥ 18 years
• Pathologic confirmation of pancreatic ductal adenocarcinoma
• Resectable disease (determined by treating surgeon)
• Patients planning to receive neoadjuvant Folfirinox as part of their standard of care treatment
• No evidence of distant organ metastatic disease
• Eastern Cooperative Oncology Group Performance status 0-1
• Ability to understand and the willingness to sign informed consent document
• Adequate organ function, defined by the following laboratory values, at the time of study entry:
• Hemoglobin ≥ 10 g/dL (transfusions acceptable)
• Absolute Neutrophil Count ≥ 0.5 x 109/L
• Platelets ≥ 100 x 109/L
• Creatinine ≤ 1.5x institutional upper limit of normal (ULN) or creatinine clearance ≥ 50 mL/min
• Total bilirubin ≤ 2x institutional ULN
• Aspartate aminotransferase test (AST)/ Alanine Aminotransferase Test (ALT) ≤ 3x institutional ULD

You may not qualify if:

• 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
• Prior therapy for PDAC
• Prior radiation to the upper abdomen (RT to other sites acceptable)
• Inability to undergo port or PICC line placement
• Active gastric or duodenal ulcer
• Tumor invasion of the intestinal or gastric lumen
• Active hepatitis B or other active serious infections
• 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
• Life expectancy of \< 3 months
• 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.

Sponsors & Collaborators

• Indiana University: lead

Study Sites (1)

Indiana University Melvin & Bren Simon Cancer Center

Indianapolis, Indiana, 46202, United States

Location

MeSH Terms

Conditions

Pancreatic Neoplasms; Neoplasms

Interventions

Radiosurgery; folfirinox

Condition Hierarchy (Ancestors)

Digestive System Neoplasms; Neoplasms by Site; Endocrine Gland Neoplasms; Digestive System Diseases; Pancreatic Diseases; Endocrine System Diseases

Intervention Hierarchy (Ancestors)

Radiotherapy; Therapeutics; Stereotaxic Techniques; Neurosurgical Procedures; Surgical Procedures, Operative; Investigative Techniques

Study Officials

• Susannah Ellsworth, MD

  Indiana University School of Medicine

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Assistant Professor of Radiation Oncology

Model Details: preoperative chemotherapy with FOLFIRINOX followed by SBRT in patients with resectable pancreatic cancer.

Study Record Dates

• First Submitted: October 15, 2019
• First Posted: October 17, 2019
• Study Start: July 1, 2019
• Primary Completion: January 1, 2022
• Study Completion: January 1, 2023
• Last Updated: October 17, 2019

Record last verified: 2019-09

Locations

US (1)