Intrabdominal Hyperthermic Chemotherapy and Pancreatic Cancer

NCT03251365 | Unknown Phase 2 DMC

• 2 other identifiers: Pancreathipec 1.02016-004298-41
• Study Type: interventional
• Target: 42
• Locations: 1 country
• Sites: 1

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

Conditions

Resectable Pancreatic Adenocarcinoma

Keywords

Pancreatic cancer; Gemcitabine; Pancreatic carcinomatosis; Intrabdominal hyperthermic chemotherapy

Outcome Measures

Primary Outcomes (2)

• 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

Study Arms (2)

Group I, Normal

NO INTERVENTION

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,experimental.HIPEC-Gemcitabine

EXPERIMENTAL

• 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

Interventions

HIPEC-gemcitabine DRUG

• 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

Group II,experimental.HIPEC-Gemcitabine

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• · Resectable pancreatic adenocarcinoma

You may not qualify if:

• 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

Sponsors & Collaborators

• Hospital General de Ciudad Real: lead

Study Sites (1)

Hospital Universitario de Ciudad Real, HGUCR

Ciudad Real, 13005, Spain

RECRUITING

MeSH Terms

Conditions

Pancreatic Neoplasms

Condition Hierarchy (Ancestors)

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

Central Study Contacts

David Padilla-Valverde, MD,PhD

CONTACT

34926278000; Davidp@sescam.jccm.es

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: PARTICIPANT, INVESTIGATOR
• Masking Details: 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.
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Chief of Hepatobiliary Unit, Department of Surgery,HGUCR.Coordinator of Research Traslational Unit,HGUCR.Professor of Surgery, Faculty of Medicine, UCLM, Ciudad Real, Spain

Model Details: 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.

Study Record Dates

• First Submitted: August 6, 2017
• First Posted: August 16, 2017
• Study Start: July 27, 2017
• Primary Completion: December 31, 2020
• Study Completion: December 31, 2024
• Last Updated: August 16, 2017

Record last verified: 2017-08

Locations

ES (1)