Intrabdominal hyperthermic chemotherapy to treat pancreatic carcinomatosis

Phase 1

• Conditions: A population of malignant transformation stem cells, called tumor stem cells, extremely resistant to chemotherapeutic drugs, has been identified as the origin of pancreatic cancer. In our study, we developed a new therapeutic model, characterized by the application of hyperthermal intraabdominal chemotherapy with Gemcitabine, in order to eliminate locoregional tumor stem cells and improve the prognosis of neoplastic pancreatic disease; Therapeutic area: Diseases [C] - Digestive System Diseases [C06]

• Registration Number: EUCTR2016-004298-41-ES
• Lead Sponsor: Hospital General Ciudad Real

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Study Start: 2017-03-31
• Last Update Posted: 3 July 2017

Recruitment & Eligibility

• Status: Authorised-recruitment may be ongoing or finished
• Sex: All
• Target Recruitment: 42

Inclusion Criteria

Surgically resectable pancreatic adenocarcinoma
Are the trial subjects under 18? no
Number of subjects for this age range:
F.1.2 Adults (18-64 years) yes
F.1.2.1 Number of subjects for this age range 21
F.1.3 Elderly (>=65 years) yes
F.1.3.1 Number of subjects for this age range 21

Exclusion Criteria

· Voluntary refusal to participate in the trial
· Existence of distant or locoregional disease that contraindicates surgical treatment, diagnosed preoperatively or in the intraoperative act
· Existence of synchronous neoplastic disease
· Exclusion after perioperative anesthetic study

Study & Design

• Study Type: Interventional clinical trial of medicinal product
• Study Design: Not specified