Borderline Pancreas Study: FOLFIRINOX +SBRT

NCT01992705 | Completed Early Phase 1 DMC

• 1 other identifier: HP-00055716
• Study Type: interventional
• Target: 8
• Locations: 1 country
• Sites: 1

Brief Summary

Primary Objective: To determine the rate of downstaging to resectability in patients with borderline resectable pancreatic cancer receiving FOLFIRINOX and SBRT as preoperative therapy. Secondary Objective(s):

1. 1.To assess the disease-free-survival, overall survival, time to recurrence and site of recurrence in patients with borderline resectable pancreatic cancer receiving preoperative FOLFIRINOX followed by SBRT
2. 2.To investigate the safety and tolerability of FOLFIRINOX and SBRT in patients with resectable pancreatic cancer
3. 3.To determine the radiologic and pathological response associated with preoperative SBRT and FOLFIRINOX therapy
4. 4.To assess quality of life through and after treatment using the FACT-Hep questionnaire

Conditions

Resectable Pancreatic Cancer

Keywords

pancreatic cancer

Outcome Measures

Primary Outcomes (1)

• Rate of downstaging to resectability in patients with borderline resectable pancreatic cancer receiving FOLFIRINOX and SBRT as preoperative therapy.

  To determine the rate of downstaging to resectability in patients with borderline resectable pancreatic cancer receiving FOLFIRINOX and SBRT as preoperative therapy (AGGC 6th edition).

  Participants will be followed from randomization up to 120 months or death (from any cause) whichever comes first.

Secondary Outcomes (1)

• Survival status (disease-free-survival vs. overall survival) time to recurrence and site of recurrence in patients with borderline resectable pancreatic cancer receiving preoperative FOLFIRINOX followed by SBRT

  Participants will be followed from randomization up to 120 months or death (from any cause) whichever comes first.

Other Outcomes (3)

• Number of adverse events/toxicites reported during and following treatment of FOLFIRINOX and SBRT in patients with resectable pancreatic cancer

  Participants will be followed from randomization up to 120 months or death (from any cause) whichever comes first.

• Radiologic and pathological response associated with preoperative SBRT and FOLFIRINOX therapy

  Participants will be followed from randomization up to 120 months or death (from any cause) whichever comes first.

• Quality of life through and after treatment

  Participants will be followed from randomization up to 120 months or death (from any cause) whichever comes first.

Study Arms (1)

Chemotherapy+SBRT prior to surgery if applicable

OTHER

FOLFIRINOX Drugs: * Calcium Folinate (Folinic Acid) 400 mg IV on Day 1 of each cycle (21d/cycle for a total of 4 cycles. Stereotactic Body Radiotherapy (SBRT): 30 Gy in 5 fractions given to radiographically defined pancreatic mass alone

Other: Chemotherapy(FOLFIRINOX) + SBRT prior to surgery if applicable; Drug: -Oxaliplatin 85 mg/m2 IV on Day 1; Drug: -Irinotecan 180 mg/m2 IV on Day 1; Drug: -5-FU (Fluorouracil) 2,400 mg/m2 IV over 46-48 hours

Interventions

Chemotherapy(FOLFIRINOX) + SBRT prior to surgery if applicable OTHER

Patients will receive chemotherapy (21d/cycle for a total of 4 cycles) plus SBRT before screening for surgical resection of the pancreas.

Chemotherapy+SBRT prior to surgery if applicable

-Oxaliplatin 85 mg/m2 IV on Day 1 DRUG

Oxaliplatin 85 mg/m2 IV on Day 1 of each cycle (21d/cycle for a total of 4 cycles).

Chemotherapy+SBRT prior to surgery if applicable

-Irinotecan 180 mg/m2 IV on Day 1 DRUG

Irinotecan 180 mg/m2 IV on Day 1 of each cycle (21d/cycle for a total of 4 cycles).

Chemotherapy+SBRT prior to surgery if applicable

-5-FU (Fluorouracil) 2,400 mg/m2 IV over 46-48 hours DRUG

5-FU (Fluorouracil) 2,400 mg/m2 IV over 46-48 hours of each cycle (21d/cycle for a total of 4 cycles.

Chemotherapy+SBRT prior to surgery if applicable

Eligibility Criteria

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

You may qualify if:

• ≥ 18 years at diagnosis.
• Biopsy proven pancreatic adenocarcinoma.
• Borderline resectable per NCCN criteria (No distant metastases, venous involvement of the portal vein/SMV, demonstrating tumor abutment and narrowing of the lumen, encasement of the portal vein/SMV without encasement of the nearby arteries, or short-segment venous occlusion resulting from either tumor thrombus or encasement but with suitable vessel proximal or distal to this area of vessel involvement, allowing for safe resection and reconstruction; gastroduodenal artery encasement up to the hepatic artery with either short segment encasement or direct abutment of the hepatic artery, without extension to the celiac axis; tumor abutment of the SMA not to exceed 180 degrees of the circumference of the vessel wall.).
• Radiologically measurable or clinically evaluable disease.
• Pancreas protocol CT and/or MRI if required for further clarification of disease tissue planes within 4 weeks of registration.
• ECOG PS of 0-2.
• Able to get a Whipple resection per surgeon assessment performed within 4 weeks of registration.
• The following laboratory values obtained ≤ 28 days prior to registration:
• Absolute neutrophil count (ANC) ≥ 1,500/mm3.
• Platelet count ≥ 100,000/mm3.
• Hemoglobin \> 8.0 g/dL.
• Total bilirubin ≤ 1.5 x upper limit of normal (ULN).
• SGOT (AST) ≤ 2 x ULN.
• SGPT (ALT) ≤ 2 x ULN.
• Creatinine ≤ 1.5 x ULN.

You may not qualify if:

• Any pancreatic adenocarcinoma that does not meet criteria for borderline resectable disease.
• Prior history of abdominal radiation therapy.
• History of autoimmune disease such as scleroderma, lupus, and inflammatory bowel disease.
• Patients with tumor-caused symptomatic bowel obstruction.
• Chemotherapy (including hormonal therapy) within the past 5 years from date of registration.
• Other invasive malignancies within the past 5 years from date of registration.
• Pregnant or nursing women or women of childbearing age that are unwilling to employ adequate contraception.
• Other co-morbid conditions which, based on the judgment of the physicians obtaining informed consent, would make the patient inappropriate for this study.

Sponsors & Collaborators

• University of Maryland, Baltimore: lead

Study Sites (1)

University of Maryland Medical Center

Baltimore, Maryland, 21201, United States

Location

MeSH Terms

Conditions

Pancreatic Neoplasms

Interventions

Oxaliplatin; Irinotecan; Fluorouracil

Condition Hierarchy (Ancestors)

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

Intervention Hierarchy (Ancestors)

Coordination Complexes; Organic Chemicals; Camptothecin; Alkaloids; Heterocyclic Compounds; Uracil; Pyrimidinones; Pyrimidines; Heterocyclic Compounds, 1-Ring

Study Officials

• Shahed Badiyan, MD

  University of Maryland, College Park

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: early phase 1
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Principal Investigator

Study Record Dates

• First Submitted: September 27, 2013
• First Posted: November 25, 2013
• Study Start: March 1, 2014
• Primary Completion: September 27, 2018
• Study Completion: September 27, 2018
• Last Updated: August 19, 2019

Record last verified: 2019-08

Locations

US (1)