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

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ClinicalTrials.gov Identifier: NCT02243358
Recruitment Status : Unknown
Verified October 2016 by Gazala Khan, MD, Henry Ford Health System.
Recruitment status was:  Recruiting
First Posted : September 17, 2014
Last Update Posted : October 14, 2016
Sponsor:
Information provided by (Responsible Party):
Gazala Khan, MD, Henry Ford Health System

Brief Summary:
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.

Condition or disease Intervention/treatment Phase
Pancreas Neoplasm Malignant Resectable Drug: Folfox6 Drug: Gemcitabine Radiation: Radiation Therapy Procedure: Pancreaticoduodenectomy with retroperitoneal lymphadenectomy Phase 2

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.


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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 20 participants
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: A Neoadjuvant Phase II Study of Chemo-Radiotherapy in Patients With Resectable and Borderline Resectable Pancreatic Cancer
Study Start Date : February 2014
Estimated Primary Completion Date : February 2018

Resource links provided by the National Library of Medicine



Intervention Details:
  • Drug: Folfox6
    Other Name: 5 Fluoropyrymidine
  • Drug: Gemcitabine
    Other Name: Gemzar
  • Radiation: Radiation Therapy
  • Procedure: Pancreaticoduodenectomy with retroperitoneal lymphadenectomy


Primary Outcome Measures :
  1. Primary Tumor Response [ Time Frame: 6 weeks ]
    Diagnostic imaging and RECIST criteria will be used to evaluate and record response of the primary tumor



Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years to 99 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

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

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): NCT02243358


Contacts
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Contact: Tiffany Pearce, BS 313-916-1784 tpearce1@hfhs.org
Contact: Jennifer Carabio, BS 313-916-1827 jcarabi1@hfhs.org

Locations
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United States, Michigan
Henry Ford Health System Recruiting
Detroit, Michigan, United States, 48202
Contact: Tiffany Pearce, BS    313-916-1784    tpearce1@hfhs.org   
Contact: Jennifer Carabio, BS    313-916-1827    jcarabi1@hfhs.org   
Principal Investigator: Gazala Kahn, MD         
Sponsors and Collaborators
Henry Ford Health System
Investigators
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Principal Investigator: Gazala Khan, MD Henry Ford Health System

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Responsible Party: Gazala Khan, MD, MD, Henry Ford Health System
ClinicalTrials.gov Identifier: NCT02243358     History of Changes
Other Study ID Numbers: HFHS 13-03
First Posted: September 17, 2014    Key Record Dates
Last Update Posted: October 14, 2016
Last Verified: October 2016
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: Yes
Plan Description: Through publication in peer reviewed journal
Keywords provided by Gazala Khan, MD, Henry Ford Health System:
Pancreatic, cancer
Additional relevant MeSH terms:
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Pancreatic Neoplasms
Neoplasms
Digestive System Neoplasms
Neoplasms by Site
Endocrine Gland Neoplasms
Pancreatic Diseases
Digestive System Diseases
Endocrine System Diseases
Gemcitabine
Antimetabolites, Antineoplastic
Antimetabolites
Molecular Mechanisms of Pharmacological Action
Antineoplastic Agents
Antiviral Agents
Anti-Infective Agents
Enzyme Inhibitors
Immunosuppressive Agents
Immunologic Factors
Physiological Effects of Drugs