Intrabdominal Hyperthermic Chemotherapy and Pancreatic Cancer

Resectable Pancreatic Adenocarcinoma Clinical Trial

Official title:

Intrabdominal Hyperthermic Chemotherapy Using Gemcitabine to Treat Pancreatic Carcinomatosis

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT03251365
• Other study ID #: Pancreathipec 1.0
• Secondary ID: 2016-004298-41
• Status: Recruiting
• Phase: Phase 2/Phase 3
• First received: August 6, 2017
• Last updated: August 13, 2017
• Start date: July 27, 2017
• Est. completion date: December 31, 2024

Study information

• Verified date: August 2017
• Source: Hospital General de Ciudad Real
• Contact: David Padilla-Valverde, MD,PhD
• Phone: 34926278000
• Email: Davidp[@]sescam.jccm.es
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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

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

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 42
• Est. completion date: December 31, 2024
• Est. primary completion date: December 31, 2020
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 18 Years and older

Eligibility

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

Related Conditions & MeSH terms

• Adenocarcinoma
• Fever
• Resectable Pancreatic Adenocarcinoma

Intervention

Drug:
• HIPEC-gemcitabine
• 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

Locations

Country	Name	City	State
Spain	Hospital Universitario de Ciudad Real, HGUCR	Ciudad Real

Sponsors (1)

Lead Sponsor	Collaborator
Hospital General de Ciudad Real

Country where clinical trial is conducted

Spain, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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
Primary	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