Phase II Study of Chemo-Radiotherapy in Patients With Resectable and Borderline Resectable Pancreatic Cancer

October 25, 2023 updated by: Gazala Khan, MD, Henry Ford Health System

A Neoadjuvant Phase II Study of Chemo-Radiotherapy in Patients With Resectable and Borderline Resectable Pancreatic Cancer

To evaluate the safety and effectiveness of a novel neoadjuvant treatment strategy incorporating 5-fluorouracil/leucovorin with oxaliplatin ( FOLFOX )chemotherapy in combination with chemo-radiation with gemcitabine.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Detailed Description

The primary objective is to evaluate frequency of achieving complete resection ( RO resection )in patients with resectable and borderline resectable pancreatic cancer treated with a neoadjuvant regimen of FOLFOX followed by radiation therapy (RT) concurrent with gemcitabine chemotherapy at standard dosing.

Secondary objectives are to determine overall survival and progression-free survival as a function of time from study enrollment and to evaluate tolerability and toxicity of protocol treatment.

Eligible patients with resectable and borderline resectable pancreatic cancer will be accrued onto protocol therapy, which would include a neo-adjuvant phase followed by surgical resection. A cycle of FOLFOX treatment is 14 days. 2 cycles are intended prior to combined modality treatment. Combined modality treatment will begin 2 weeks (plus or minus 2 days) after the last FOLFOX administration. (Gemcitabine 1000mg/m² will be infused over 30 minutes on days 1, 8, 22, and 29 during the 5-week course of radiation treatment. The surgical procedure performed will be that required for a complete resection, and this will be based on the discretion of the operating surgeon. Patients will be followed for 1 year after completion of neoadjuvant therapy or until removal or termination from study, or until death, whichever occurs first. Patients will be seen in follow-up ever 3+/- 1 months for 1 year from completion of protocol therapy.

Study Type

Interventional

Enrollment (Actual)

24

Phase

  • Phase 2

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • United States
    • Michigan
      • Detroit, Michigan, United States, 48202
        • Henry Ford Health System

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years to 99 years (Adult, Older Adult)

Accepts Healthy Volunteers

No

Description

Inclusion Criteria:

  • Patients must have histologically or cytologically confirmed pancreatic adenocarcinoma of the pancreatic head or body
  • Patients must have radiographically-confirmed surgically resectable or borderline resectable disease at study entry staged at T1-3, NO-1 and MO
  • Age >/= 18years
  • Life expectancy of greater than 6 months in the opinion of the investigator, excluding theh pancreatic cancer
  • Eastern Cooperative Oncology Group (ECOG) performance status </= 1
  • Required laboratory data (see protocol)
  • Disease assessment by CT scan within 4 weeks of study entry
  • Ability to understand and the willingness to sign a written informed consent document

Exclusion Criteria:

  • Patients may not be receiving any other investigational agent
  • Patients with metastatic disease are excluded from this clinical trial
  • History of allergic reactions attributed to Fluorouracil (5FU), oxaliplatin and gemcitabine
  • No prior chemotherapy or radiation therapy for pancreatic cancer (previous chemotherapy or radiation therapy for other malignancies is permitted)
  • Patients with uncontrolled hypocalcemia, hypomagnesemia, hyponatremia, hypophosphatemia or hypokalemia defined as less than the lower limit of normal for the institution, despite adequate electrolyte supplementation are excluded from this study.
  • Uncontrolled serious intercurrent illness including, but not limited to, ongoing or serious active infection requiring IV antibiotics for over 30 days, symptomatic congestive heart failure, unstable angina pectoris, cardiac arrhythmia other than chronic, stable atrial fibrillation, or psychiatric illness/social situations that would limit compliance with study requirements
  • Pregnant or breastfeeding women are excluded from this study.
  • Known HIV-positive patients are ineligible
  • Patients with unresectable disease are excluded form the protocol (see Appendix B for National Comprehensive cancer Network [NCCN] criteria for determining resectability status). Surgical resectability must be confirmed by a surgeon experienced in pancreatic surgery.
  • Patients with pancreatic tail lesions will be excluded

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: N/A
  • Interventional Model: Single Group Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: Neoadjuvant Chemo-Radiotherapy and Resection
2 cycles - FOLFOX6 (1 month) Gemcitabine/RT (5-6 weeks) Rest period 2 weeks Re-staging evaluation (CT scan to be done during the 2 weeks of rest) Surgery (To be performed no later than 6 weeks after completion of chemo-radiation)
Drug: Gemcitabine
Other Names:
  • Gemzar
Radiation: Radiation Therapy
Drug: Folfox6
Other Names:
  • 5 fluoropyrimidine
Procedure: Pancreaticoduodenectomy with retroperitoneal lymphadenectomy

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Frequency of R0 Resection
Time Frame: 6 weeks
Evaluate frequency of achieving R0 resection in patients with resectable and borderline resectable pancreatic cancer treated with a neoadjuvant regimen of FOLFOX followed by RT concurrent with gemcitabine chemotherapy at standard dosing
6 weeks

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Henry Ford Health System

Investigators

  • Principal Investigator: Gazala Khan, MD, Henry Ford Health System

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

February 1, 2014

Primary Completion (Actual)

June 28, 2017

Study Completion (Actual)

January 14, 2020

Study Registration Dates

First Submitted

September 4, 2014

First Submitted That Met QC Criteria

September 15, 2014

First Posted (Estimated)

September 17, 2014

Study Record Updates

Last Update Posted (Actual)

October 27, 2023

Last Update Submitted That Met QC Criteria

October 25, 2023

Last Verified

October 1, 2023

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • HFHS 13-03

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

YES

IPD Plan Description

Through publication in peer reviewed journal

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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