Resectable Pancreatic Adenocarcinoma Clinical Trial
Official title:
Intrabdominal Hyperthermic Chemotherapy Using Gemcitabine to Treat Pancreatic Carcinomatosis
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
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
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