Intrabdominal Hyperthermic Chemotherapy and Pancreatic Cancer

Study Overview
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Brief Summary
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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
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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

Official Title
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Intrabdominal Hyperthermic Chemotherapy Using Gemcitabine to Treat Pancreatic Carcinomatosis

Conditions
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Resectable Pancreatic Adenocarcinoma

Intervention / Treatment
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* Drug: HIPEC-gemcitabine


Participation Criteria
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Eligibility Criteria
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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

Ages Eligible for Study
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Minimum Age: 18 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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Accepts Healthy Volunteers

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Interventional 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: Double


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| No Intervention: Group I, Normal<br>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<br>• 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<br>* • 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<br>|

What is the study measuring?
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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 | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Pancreatic cancer, Gemcitabine, Pancreatic carcinomatosis, Intrabdominal hyperthermic chemotherapy