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

NCT02243358 | Completed Phase 2 Results

• 1 other identifier: HFHS 13-03
• Study Type: interventional
• Target: 24
• Locations: 1 country
• Sites: 1

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.

Conditions

Pancreas Neoplasm Malignant Resectable

Keywords

Pancreatic, cancer

Outcome Measures

Primary Outcomes (1)

• 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

Study Arms (1)

Neoadjuvant Chemo-Radiotherapy and Resection

EXPERIMENTAL

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

Interventions

Folfox6 DRUG

Also known as: 5 fluoropyrimidine

Neoadjuvant Chemo-Radiotherapy and Resection

Gemcitabine DRUG

Also known as: Gemzar

Neoadjuvant Chemo-Radiotherapy and Resection

Radiation Therapy RADIATION

Neoadjuvant Chemo-Radiotherapy and Resection

Pancreaticoduodenectomy with retroperitoneal lymphadenectomy PROCEDURE

Neoadjuvant Chemo-Radiotherapy and Resection

Eligibility Criteria

• Age: 18 Years - 99 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• Henry Ford Health System: lead

Study Sites (1)

Henry Ford Health System

Detroit, Michigan, 48202, United States

Location

Related Publications (1)

• 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.

  PMID: 32251119 RESULT

MeSH Terms

Conditions

Pancreatic Neoplasms

Interventions

Folfox protocol; 5-fluoropyrimidine; Gemcitabine; Radiotherapy; Pancreaticoduodenectomy

Condition Hierarchy (Ancestors)

Digestive System Neoplasms; Neoplasms by Site; Neoplasms; Endocrine Gland Neoplasms; Digestive System Diseases; Pancreatic Diseases; Endocrine System Diseases

Intervention Hierarchy (Ancestors)

Heterocyclic Compounds; Deoxycytidine; Cytidine; Pyrimidine Nucleosides; Pyrimidines; Heterocyclic Compounds, 1-Ring; Therapeutics; Digestive System Surgical Procedures; Surgical Procedures, Operative

Results Point of Contact

• Title: Dr. Gazala Khan, MD
• Organization: Henry Ford Cancer Institute

gkhan1@hfhs.org

313-598-2860

Study Officials

• Gazala Khan, MD

  Henry Ford Health System

  PRINCIPAL INVESTIGATOR

Publication Agreements

• PI is Sponsor Employee: Yes

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: MD

Study Record Dates

• First Submitted: September 4, 2014
• First Posted: September 17, 2014
• Study Start: February 1, 2014
• Primary Completion: June 28, 2017
• Study Completion: January 14, 2020
• Last Updated: October 27, 2023
• Results First Posted: October 27, 2023

Record last verified: 2023-10

Data Sharing

• IPD Sharing: Will share

Locations

US (1)