Intrabdominal Hyperthermic Chemotherapy and Pancreatic Cancer

Intrabdominal Hyperthermic Chemotherapy Using Gemcitabine to Treat Pancreatic Carcinomatosis

A randomized, multidisciplinary study, Phase II-III clinical trial.The study is opened to the incorporation of other centers that would increase the power of the obtained results . Our hypothesis considers that using Hyperthermic Intra-abdominal Chemotherapy,HIPEC, with gemcitabine after cytoreductive surgery ,will decrease tumor progression of pancreatic cancer by reducing the neoplastic volume and subpopulation of pancreatic cancer stem cells, improving the survival of patients with pancreatic cancer, and decreasing the recurrence of the disease

Study Overview

• Status: Recruiting
• Conditions: Resectable Pancreatic Adenocarcinoma
• Intervention / Treatment: Drug: HIPEC-gemcitabine

Detailed Description

According to the incidence in the area of the University General Hospital, Ciudad Real, HGUCR, authors will include a population of 42 patients, n = 21 in each group, I and II, with diagnosis of adenocarcinoma of the pancreas, which will be surgically resected with curative intention, in the next two years, 2017-2018, with extended follow-up for at least two years more for survival study Accepting an alpha risk of 0.05 and a beta risk of 0.2 in a bilateral contrast, 21 subjects were required in the first group and 21 participants in the second Group to detect as statistically significant difference between two proportions, for group I is expected to be 0.05 and for Group II 0.4, in relation to survival in five years. It has been estimated a rate of loss of patients of 10%

• Group I. After cytoreductive surgery, R0, and intestinal reconstruction, the patient after multidisciplinary study will receive adjuvant treatment with iv gemcitabine , 1000 mg / m2 for at least 4 cycles
• Group II.After a R0 cytoreductive surgery, HIPEC is performed with gemcitabine, 120mg / m2 for 30' + adjuvant treatment with iv gemcitabine , 1000 mg / m2 for at least 4 cycles The aim is identifying morbidity and mortality associated to treatment by cytoreductive surgery and HIPEC with gemcitabine+ systemic chemotherapy,Group II, respect to a conventional treatment group that includes cytoreductive surgery with systemic chemotherapy, Group I,and identifying survival of the experimental Group with treatment with cytoreductive surgery and HIPEC with gemcitabine ,respect to the conventional treatment group,GI

• Study Type: Interventional
• Enrollment (Anticipated): 42
• Phase: Phase 2; Phase 3

Contacts and Locations

• Study Contact: Name: David Padilla-Valverde, MD,PhD; Phone Number: 79784 34926278000; Email: Davidp@sescam.jccm.es

Study Locations

• Spain
  • Ciudad Real, Spain, 13005
    • Recruiting
    • Hospital Universitario de Ciudad Real, HGUCR
    • Contact: Javier Redondo-Calvo, MD,PhD; Phone Number: 79784 34926278000; Email: ardredondo@hotmail.com

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

Inclusion Criteria:

· Resectable pancreatic adenocarcinoma

Exclusion Criteria:

• Voluntary refusal to participate in the trial
• Existence of distant disease that contraindicates the surgical treatment
• Patients with preoperative or intraoperative locoregional unresectable pancreatic cancer
• Existence of synchronous neoplastic disease
• Exclusion after perioperative anesthetic study

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Double

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
No Intervention: Group I, Normal; Group I. After cytoreductive surgery, R0, and intestinal reconstruction, the patient after multidisciplinary study will receive adjuvant treatment with iv gemcitabine , 1000 mg / m2 for at least 4 cycles
Experimental: Group II,experimental.HIPEC-Gemcitabine; • Group II.After a R0 cytoreductive surgery, HIPEC is performed with gemcitabine, 120mg / m2 for 30' + adjuvant treatment with iv gemcitabine , 1000 mg / m2 for at least 4 cycles	Drug: HIPEC-gemcitabine; • Group II.After a R0 cytoreductive surgery, HIPEC is performed with gemcitabine, 120mg / m2 for 30' + adjuvant treatment with iv gemcitabine , 1000 mg / m2 for at least 4 cycles

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Morbidity	• Identify morbidity associated to treatment by cytoreductive surgery and HIPEC with gemcitabine+ systemic chemotherapy,Group II, respect to a conventional treatment group that includes cytoreductive surgery with systemic chemotherapy, Group I	30 days
Survival	• Identify survival of the experimental Group with treatment with cytoreductive surgery and HIPEC with gemcitabine ,respect to the conventional treatment group,GI	18 months

Collaborators and Investigators

• Sponsor: Hospital General de Ciudad Real

Study record dates

Study Major Dates

• Study Start (Actual): July 27, 2017
• Primary Completion (Anticipated): December 31, 2020
• Study Completion (Anticipated): December 31, 2024

Study Registration Dates

• First Submitted: August 6, 2017
• First Submitted That Met QC Criteria: August 13, 2017
• First Posted (Actual): August 16, 2017

Study Record Updates

• Last Update Posted (Actual): August 16, 2017
• Last Update Submitted That Met QC Criteria: August 13, 2017
• Last Verified: August 1, 2017

More Information

Terms related to this study

• Keywords: Gemcitabine; Pancreatic cancer; Pancreatic carcinomatosis; Intrabdominal hyperthermic chemotherapy
• Additional Relevant MeSH Terms: Wounds and Injuries; Body Temperature Changes; Heat Stress Disorders; Hyperthermia; Fever; Physiological Effects of Drugs; Molecular Mechanisms of Pharmacological Action; Anti-Infective Agents; Antiviral Agents; Enzyme Inhibitors; Antimetabolites, Antineoplastic; Antimetabolites; Antineoplastic Agents; Immunosuppressive Agents; Immunologic Factors; Gemcitabine
• Other Study ID Numbers: Pancreathipec 1.0; 2016-004298-41 (EudraCT Number)

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: Undecided

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No
• product manufactured in and exported from the U.S.: No