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Borderline Pancreas Study: FOLFIRINOX +SBRT (GCC 1324)

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ClinicalTrials.gov Identifier: NCT01992705
Recruitment Status : Completed
First Posted : November 25, 2013
Last Update Posted : August 19, 2019
Sponsor:
Information provided by (Responsible Party):
Department of Radiation Oncology, University of Maryland, Baltimore

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. 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. To investigate the safety and tolerability of FOLFIRINOX and SBRT in patients with resectable pancreatic cancer
  3. To determine the radiologic and pathological response associated with preoperative SBRT and FOLFIRINOX therapy
  4. To assess quality of life through and after treatment using the FACT-Hep questionnaire

Condition or disease Intervention/treatment Phase
Resectable Pancreatic Cancer 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 Early Phase 1

Detailed Description:

The study investigators hypothesize that neoadjuvant FOLFIRINOX can be safely and efficaciously delivered using a sequential regimen with SBRT as an alternative to standard neoadjuvant chemoradiotherapy. Standard of care neoadjuvant treatment typically requires about six weeks of treatment with sub-systemic dosing of chemotherapy. The feasibility of the sequential delivery of the FOLFIRINOX followed by SBRT will be evaluated by capturing the prevalence of grade 3 toxicity and the treatment delay rate.

In our study, SBRT is planned sequentially to follow cycle 4 of chemotherapy treatment, provided toxicity has resolved to grade 2 or less. Thus, allowing for resolution of chemotherapy toxicity prior to initiation of radiation therapy. This interval and the fact that there is no concurrent delivery of chemo-RT, based on previously discussed experiences, including approaches where SBRT safely follows other intense chemotherapy regimens (see Polistina et al and Chuong [35,36]) makes this study feasible without establishing toxicity profile.

The proposed regimen of 4 cycles of FOLFIRINOX followed by 30 Gy/5 fractions using SBRT will be safely tolerated and will improve resectability rates in borderline resectable PDAC patients. In addition, this regimen will not compromise the ability to achieve a successful Whipple resection.

This regimen will improve the local control rate and overall disease free survival in this patient population. The investigators further hypothesize that early administration of FOLFIRNOX will provide optimal systemic therapy to control clinically occult micrometastases.


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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 8 participants
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: Neoadjuvant FOLFIRINOX and Stereotactic Body Radiotherapy (SBRT) Followed by Definitive Surgery for Patients With Borderline Resectable Pancreatic Adenocarcinoma: A Single-Arm Pilot Study
Study Start Date : March 2014
Actual Primary Completion Date : September 27, 2018
Actual Study Completion Date : September 27, 2018

Resource links provided by the National Library of Medicine


Arm Intervention/treatment
Chemotherapy+SBRT prior to surgery if applicable

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

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

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

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




Primary Outcome Measures :
  1. Rate of downstaging to resectability in patients with borderline resectable pancreatic cancer receiving FOLFIRINOX and SBRT as preoperative therapy. [ Time Frame: Participants will be followed from randomization up to 120 months or death (from any cause) whichever comes first. ]
    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).


Secondary Outcome Measures :
  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 [ Time Frame: Participants will be followed from randomization up to 120 months or death (from any cause) whichever comes first. ]
    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 (RECIST)


Other Outcome Measures:
  1. Number of adverse events/toxicites reported during and following treatment of FOLFIRINOX and SBRT in patients with resectable pancreatic cancer [ Time Frame: Participants will be followed from randomization up to 120 months or death (from any cause) whichever comes first. ]
    Number of toxicities participants reported by participants during and following treatment with FOLFIRINOX and SBRT in patients with resectable pancreatic cancer (NIH CTCAE v.4).

  2. Radiologic and pathological response associated with preoperative SBRT and FOLFIRINOX therapy [ Time Frame: Participants will be followed from randomization up to 120 months or death (from any cause) whichever comes first. ]
    To determine the radiologic and pathological response associated with preoperative SBRT and FOLFIRINOX therapy (review of radiology and pathology reports).

  3. Quality of life through and after treatment [ Time Frame: Participants will be followed from randomization up to 120 months or death (from any cause) whichever comes first. ]
    To assess quality of life through and after treatment using the FACT-Hep questionnaire



Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • ≥ 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.
  • CA 19-9 level (to establish baseline).
  • A negative pregnancy test within 7 days prior to registration for women of childbearing potential. In addition, male and female participants must commit to adequate contraception while on study.
  • Able to provide written informed consent.
  • Willing to return for all required study assessments.
  • Neurological assessment for pre-existing peripheral neuropathy.
  • Documentation of pre-existing hearing deficits.

Exclusion Criteria:

  • 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.

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): NCT01992705


Locations
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United States, Maryland
University of Maryland Medical Center
Baltimore, Maryland, United States, 21201
Sponsors and Collaborators
University of Maryland, Baltimore
Investigators
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Principal Investigator: Shahed Badiyan, MD University of Maryland, College Park

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Responsible Party: Department of Radiation Oncology, Principal Investigator, University of Maryland, Baltimore
ClinicalTrials.gov Identifier: NCT01992705     History of Changes
Other Study ID Numbers: HP-00055716
First Posted: November 25, 2013    Key Record Dates
Last Update Posted: August 19, 2019
Last Verified: August 2019
Keywords provided by Department of Radiation Oncology, University of Maryland, Baltimore:
pancreatic cancer
Additional relevant MeSH terms:
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Pancreatic Neoplasms
Digestive System Neoplasms
Neoplasms by Site
Neoplasms
Endocrine Gland Neoplasms
Pancreatic Diseases
Digestive System Diseases
Endocrine System Diseases
Oxaliplatin
Irinotecan
Fluorouracil
Antineoplastic Agents
Topoisomerase I Inhibitors
Topoisomerase Inhibitors
Enzyme Inhibitors
Molecular Mechanisms of Pharmacological Action
Antimetabolites
Antimetabolites, Antineoplastic
Immunosuppressive Agents
Immunologic Factors
Physiological Effects of Drugs