Intrabdominal Hyperthermic Chemotherapy and Pancreatic Cancer
Primary Purpose
Resectable Pancreatic Adenocarcinoma
Status
Recruiting
Phase
Phase 2
Locations
Spain
Study Type
Interventional
Intervention
HIPEC-gemcitabine
Sponsored by
About this trial
This is an interventional treatment trial for Resectable Pancreatic Adenocarcinoma focused on measuring Pancreatic cancer, Gemcitabine, Pancreatic carcinomatosis, Intrabdominal hyperthermic chemotherapy
Eligibility Criteria
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
Sites / Locations
- Hospital Universitario de Ciudad Real, HGUCRRecruiting
Arms of the Study
Arm 1
Arm 2
Arm Type
No Intervention
Experimental
Arm Label
Group I, Normal
Group II,experimental.HIPEC-Gemcitabine
Arm Description
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
Outcomes
Primary Outcome Measures
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
Survival
• Identify survival of the experimental Group with treatment with cytoreductive surgery and HIPEC with gemcitabine ,respect to the conventional treatment group,GI
Secondary Outcome Measures
Full Information
NCT ID
NCT03251365
First Posted
August 6, 2017
Last Updated
August 13, 2017
Sponsor
Hospital General de Ciudad Real
1. Study Identification
Unique Protocol Identification Number
NCT03251365
Brief Title
Intrabdominal Hyperthermic Chemotherapy and Pancreatic Cancer
Official Title
Intrabdominal Hyperthermic Chemotherapy Using Gemcitabine to Treat Pancreatic Carcinomatosis
Study Type
Interventional
2. Study Status
Record Verification Date
August 2017
Overall Recruitment Status
Recruiting
Study Start Date
July 27, 2017 (Actual)
Primary Completion Date
December 31, 2020 (Anticipated)
Study Completion Date
December 31, 2024 (Anticipated)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Hospital General de Ciudad Real
4. Oversight
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
Data Monitoring Committee
Yes
5. Study Description
Brief Summary
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
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
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Resectable Pancreatic Adenocarcinoma
Keywords
Pancreatic cancer, Gemcitabine, Pancreatic carcinomatosis, Intrabdominal hyperthermic chemotherapy
7. Study Design
Primary Purpose
Treatment
Study Phase
Phase 2, Phase 3
Interventional Study Model
Parallel Assignment
Model Description
Characteristics of the Trial: This is a randomized,interventional, multidisciplinary study,phase II-III, involving several Services as General Surgery, Pathology, Oncology, Pharmacy, Gastroenterology and Radiology at the University General Hospital of Ciudad Real and the Faculty of Medicine, and Translational Research Unit,HGUCR.The study is opened to the incorporation of other centers that increase the power of the obtained results.
Masking
ParticipantInvestigator
Masking Description
After explaining the treatment to develop once informed of the characteristics of pancreatic cancer to the patient, we will explain in detail the clinical trial that we are going to develop. After obtaining the informed consent, authors will start the randomly distribution of patients A list of randomization to 42 patients will be developed by a computer program that simulates the extraction procedure of numbered balls and the correlative allocation to each of the codes.
Randomization is by block, thereby ensuring a balanced number of subjects per treatment. Then a scrambling code in which randomly assigned treatment to each code will be developed.
The randomization code and study randomization list shall be kept only for the person that will carry the allocation of treatments.Randomization of patients will be performed centrally. Each patient is assigned to a sequential number of the centralized list of inclusion and appropriate treatment.
Allocation
Randomized
Enrollment
42 (Anticipated)
8. Arms, Groups, and Interventions
Arm Title
Group I, Normal
Arm Type
No Intervention
Arm Description
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
Arm Title
Group II,experimental.HIPEC-Gemcitabine
Arm Type
Experimental
Arm Description
• 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
Intervention Type
Drug
Intervention Name(s)
HIPEC-gemcitabine
Intervention Description
• 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
Primary Outcome Measure Information:
Title
Morbidity
Description
• 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
Time Frame
30 days
Title
Survival
Description
• Identify survival of the experimental Group with treatment with cytoreductive surgery and HIPEC with gemcitabine ,respect to the conventional treatment group,GI
Time Frame
18 months
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
Eligibility Criteria
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
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
David Padilla-Valverde, MD,PhD
Phone
34926278000
Ext
79784
Email
Davidp@sescam.jccm.es
Facility Information:
Facility Name
Hospital Universitario de Ciudad Real, HGUCR
City
Ciudad Real
ZIP/Postal Code
13005
Country
Spain
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Javier Redondo-Calvo, MD,PhD
Phone
34926278000
Ext
79784
Email
ardredondo@hotmail.com
12. IPD Sharing Statement
Plan to Share IPD
Undecided
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Intrabdominal Hyperthermic Chemotherapy and Pancreatic Cancer
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