Intrabdominal hyperthermic chemotherapy to treat pancreatic carcinomatosis

Intrabdominal hyperthermic chemotherapy using gemcitabine to treat pancreatic carcinomatosis - Intrabdominal hyperthermic chemotherapy to treat pancreatic carcinomatosis

Status

Not yet recruiting

Phases

Phase 2Phase 3

Study type

Interventional

Source

EU CTR

Registry ID

EUCTR2016-004298-41-ES

Enrollment

Registered

2017-03-31

Start date

2017-05-25

Completion date

Unknown

Last updated

2017-07-03

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

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

Interventions

Trade Name: Gemcitabine Product Name: Antagonist of pyrimidines Product Code: L01B2 Pharmaceutical Form: Concentrate and solvent for solution for injection/infusion INN or Proposed INN: GEMCITABINE CA

Eligibility

Sex/Gender

All

Inclusion criteria

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

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

Design outcomes

Primary

Measure	Time frame
Main Objective: To identify the survival and morbidity and mortality associated with treatment with cytoreductive surgery and HIPEC with Gemcitabine compared to the group with conventional treatment (Cytoreductive surgery with systemic chemotherapy);Secondary Objective: To identify the adverse effects, complications associated with treatment with cytoreductive surgery and HIPEC with Gemcitabine compared to the Group with conventional treatment (Cytoreductive surgery with systemic chemotherapy);Primary end point(s): Survival Morbidity and mortality;Timepoint(s) of evaluation of this end point: 24 months	—

Measure

Time frame

Main Objective: To identify the survival and morbidity and mortality associated with treatment with cytoreductive surgery and HIPEC with Gemcitabine compared to the group with conventional treatment (Cytoreductive surgery with systemic chemotherapy);Secondary Objective: To identify the adverse effects, complications associated with treatment with cytoreductive surgery and HIPEC with Gemcitabine compared to the Group with conventional treatment (Cytoreductive surgery with systemic chemotherapy);Primary end point(s): Survival Morbidity and mortality;Timepoint(s) of evaluation of this end point: 24 months

—

Secondary

Measure	Time frame
Secondary end point(s): Adverse effects Complications Mortality;Timepoint(s) of evaluation of this end point: During the hospital stay	—

Countries

Spain

Contacts

Public ContactHospital General Universitario de C

Hospital General Universitario de Ciudad Real

marcote15@yahoo.es34696866172

Outcome results

None listed

Source: EU CTR (via WHO ICTRP) · Data processed: Feb 4, 2026