Phase II Study Of Chemo-Radiotherapy In Patients With Resectable And Borderline Resectable Pancreatic Cancer

Study Overview

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.

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.

Pancreas Neoplasm Malignant Resectable

DRUG: Folfox6
DRUG: Gemcitabine
RADIATION: Radiation Therapy
PROCEDURE: Pancreaticoduodenectomy with retroperitoneal lymphadenectomy

HFHS 13-03

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 Registration Dates	Results Reporting Dates	Study Record Updates
First Submitted 2014-09-04	Results First Submitted 2021-11-19	Last Update Submitted that met QC Criteria 2023-10-25
First Submitted that Met QC Criteria 2014-09-15	Results First Submitted that Met QC Criteria 2023-10-25	Last Update Posted (ACTUAL) 2023-10-27
First Posted (ACTUAL) 2014-09-17	Results First Posted 2023-10-27	Last Verified 2023-10

Study Plan

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

Design Details

Primary Purpose:
Treatment

Allocation:
Na

Interventional Model:
Single Group

Masking:
None

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: Folfox6 DRUG: Gemcitabine RADIATION: Radiation Therapy PROCEDURE: Pancreaticoduodenectomy with retroperitoneal lymphadenectomy

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: Folfox6

DRUG: Gemcitabine

RADIATION: Radiation Therapy

PROCEDURE: Pancreaticoduodenectomy with retroperitoneal lymphadenectomy

Primary Outcome Measures	Measure Description	Time Frame
Frequency of R0 Resection	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

Secondary Outcome Measures	Measure Description	Time Frame

Contacts and Locations

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

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.

Ages Eligible for Study:
ALL

Sexes Eligible for Study:
18 Years

Accepts Healthy Volunteers:

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
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

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

Collaborators and Investigators

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

Investigators

PRINCIPAL_INVESTIGATOR: Gazala Khan, MD, Henry Ford Health System

Publications

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

General Publications

Thanikachalam K, Damarla V, Seixas T, Dobrosotskaya I, Wollner I, Kwon D, Winters K, Raoufi M, Li J, Siddiqui F, Khan G. Neoadjuvant Phase II Trial of Chemoradiotherapy in Patients With Resectable and Borderline Resectable Pancreatic Cancer. Am J Clin Oncol. 2020 Jun;43(6):435-441. doi: 10.1097/COC.0000000000000688.

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Clinical Trial Record