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

Primary Purpose

Pancreas Neoplasm Malignant Resectable

Status

Unknown status

Phase

Phase 2

Locations

United States

Study Type

Interventional

Intervention

Folfox6

Gemcitabine

Radiation Therapy

Pancreaticoduodenectomy with retroperitoneal lymphadenectomy

About this trial

This is an interventional treatment trial for Pancreas Neoplasm Malignant Resectable focused on measuring Pancreatic, cancer

Eligibility Criteria

18 Years - 99 Years (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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

Sites / Locations

Henry Ford Health SystemRecruiting

Outcomes

Primary Outcome Measures

Primary Tumor Response

Diagnostic imaging and RECIST criteria will be used to evaluate and record response of the primary tumor

Secondary Outcome Measures

Full Information

NCT ID

NCT02243358

First Posted

September 4, 2014

Last Updated

October 13, 2016

Sponsor

Henry Ford Health System

1. Study Identification

Unique Protocol Identification Number

NCT02243358

Brief Title

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

Official Title

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

Study Type

Interventional

2. Study Status

Record Verification Date

October 2016

Overall Recruitment Status

Unknown status

Study Start Date

February 2014 (undefined)

Primary Completion Date

February 2018 (Anticipated)

Study Completion Date

undefined (undefined)

3. Sponsor/Collaborators

Responsible Party, by Official Title

Principal Investigator

Name of the Sponsor

Henry Ford Health System

4. Oversight

Data Monitoring Committee

5. Study Description

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.

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study

Pancreas Neoplasm Malignant Resectable

Keywords

Pancreatic, cancer

7. Study Design

Primary Purpose

Treatment

Study Phase

Phase 2

Interventional Study Model

Single Group Assignment

Masking

None (Open Label)

Allocation

N/A

Enrollment

20 (Anticipated)

8. Arms, Groups, and Interventions

Intervention Type

Drug

Intervention Name(s)

Folfox6

Other Intervention Name(s)

5 Fluoropyrymidine

Intervention Type

Drug

Intervention Name(s)

Gemcitabine

Other Intervention Name(s)

Gemzar

Intervention Type

Radiation

Intervention Name(s)

Radiation Therapy

Intervention Type

Procedure

Intervention Name(s)

Pancreaticoduodenectomy with retroperitoneal lymphadenectomy

Primary Outcome Measure Information:

Title

Primary Tumor Response

Description

Diagnostic imaging and RECIST criteria will be used to evaluate and record response of the primary tumor

Time Frame

6 weeks

10. Eligibility

Sex

All

Minimum Age & Unit of Time

18 Years

Maximum Age & Unit of Time

99 Years

Accepts Healthy Volunteers

Eligibility 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

Central Contact Person:

First Name & Middle Initial & Last Name or Official Title & Degree

Tiffany Pearce, BS

Phone

313-916-1784

tpearce1@hfhs.org

First Name & Middle Initial & Last Name or Official Title & Degree

Jennifer Carabio, BS

Phone

313-916-1827

jcarabi1@hfhs.org

Overall Study Officials:

First Name & Middle Initial & Last Name & Degree

Gazala Khan, MD

Organizational Affiliation

Henry Ford Health System

Official's Role

Principal Investigator

Facility Information:

Facility Name

Henry Ford Health System

City

Detroit

State/Province

Michigan

ZIP/Postal Code

48202

Country

United States

Individual Site Status

Recruiting

Facility Contact:

First Name & Middle Initial & Last Name & Degree

Tiffany Pearce, BS

Phone

313-916-1784

tpearce1@hfhs.org

First Name & Middle Initial & Last Name & Degree

Jennifer Carabio, BS

Phone

313-916-1827

jcarabi1@hfhs.org

First Name & Middle Initial & Last Name & Degree

Gazala Kahn, MD

12. IPD Sharing Statement

Plan to Share IPD

Yes

IPD Sharing Plan Description

Through publication in peer reviewed journal

Learn more about this trial

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

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