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
;
| Status | Clinical Trial | Phase | |
|---|---|---|---|
| Recruiting |
NCT04927780 -
Perioperative or Adjuvant mFOLFIRINOX for Resectable Pancreatic Cancer
|
Phase 3 | |
| Recruiting |
NCT04940286 -
Gemcitabine, Nab-paclitaxel, Durvalumab, and Oleclumab Before Surgery for the Treatment of in Resectable/Borderline Resectable Primary Pancreatic Cancer
|
Phase 2 | |
| Enrolling by invitation |
NCT05754788 -
Gene Expression Profile of Resected Pancreatic and Ampullary Adenocarcinoma at Favorable Prognosis
|
||
| Recruiting |
NCT05066802 -
A Phase 2 Trial of Neoadjuvant Modified FOLFIRINOX Chemotherapy for Resectable Pancreatic Adenocarcinoma
|
Phase 2 | |
| Recruiting |
NCT04858334 -
APOLLO: A Randomized Phase II Double-Blind Study of Olaparib Versus Placebo Following Curative Intent Therapy in Patients With Resected Pancreatic Cancer and a Pathogenic BRCA1, BRCA2 or PALB2 Mutation
|
Phase 2 | |
| Completed |
NCT00600002 -
Administration as a Biological Adjuvant in Clinically-Staged, Resectable Pancreatic Adenocarcinoma
|
Phase 1 | |
| Not yet recruiting |
NCT06423326 -
Gemcitabine, Cisplatin and Nab-Paclitaxel as Neoadjuvant Treatment for Patients With Resectable or Borderline Resectable Pancreatic Cancer
|
Phase 2 | |
| Recruiting |
NCT04340141 -
Testing the Use of the Usual Chemotherapy Before and After Surgery for Removable Pancreatic Cancer
|
Phase 3 | |
| Recruiting |
NCT05275075 -
Identify microRNAs in Cachexia in Pancreatic Carcinoma
|
||
| Not yet recruiting |
NCT06168552 -
Fluorescent Navigation Technology in Radical Resection of Pancreatic Cancer
|
Phase 1/Phase 2 | |
| Completed |
NCT03273374 -
Intraoperative Radiation Therapy for Resectable Pancreatic Cancer
|
N/A | |
| Not yet recruiting |
NCT04915417 -
Neoadjuvant Stereotactic Ablative Radiotherapy for Pancreatic Ductal Adenocarcinoma
|
N/A |