Randomized Controlled Trial to Prevent Peritoneal Seeding in Gastric Cancer (HIPECStomach)
|ClinicalTrials.gov Identifier: NCT01683864|
Recruitment Status : Terminated (Recruitment problems)
First Posted : September 12, 2012
Results First Posted : January 30, 2018
Last Update Posted : January 30, 2018
|Condition or disease||Intervention/treatment||Phase|
|Gastric Cancer Peritoneal Carcinomatosis||Drug: positive cytology with HIPEC||Phase 2 Phase 3|
The gastric carcinoma is one of the four most common tumors occurring worldwide. The advanced phase is characterized by metastasis and poses a very poor prognosis for survival. In 20%-30% of gastric carcinomas the tumor spreads into the abdominal cavity, which leads to metastases in the wall of the peritoneal cavity. This is known as peritoneal carcinomatosis and its five-year survival rate is less than 2%. Even after R0 resection of a localized gastric carcinoma the five-year survival rate is only 40%, not least of all because relapses in the form of peritoneal metastases are a common occurrence.
Patients with gastric carcinoma and not yet diagnosed with metastases, but who show free tumor cells in cytology in preoperative laparoscopy before neoadjuvant chemotherapy and gastrectomy, have an 80% risk of developing peritoneal carcinomatosis within one year, which stands in strong contrast to the 40% risk for patients with negative cytology.
In the study presented here (group A) therapeutic hyperthermic intraperitoneal chemoperfusion (HIPEC, in the literature also known as HIIC (heated intraoperative intraperitoneal chemotherapy) or IPHC (intraperitoneal chemohyperthermia)) with mitomycin c and cisplatin will be administered following gastrectomy in patients with a gastric carcinoma with free tumor cells in cytology diagnosed in the preoperative laparoscopy in comparison to (group B) solely gastrectomy in patients with a gastric carcinoma and also with free tumor cells diagnosed in cytology in the preoperative laparoscopy.
A randomization will be performed between group A and B. Patients with gastric carcinoma (TNM Stage ≥ T2<T4) without proven metastases (TNM stage M0), with and without involved regional lymph nodes (TNM stage +N/-N) and positive cytology in preoperative abdominal lavage will be included. Exclusion criteria are extended disease or inoperable tumor.
This study is already permitted by the local ethic commission and the German Federal Institute for Drugs and Medical Devices (BfArM) (EudraCT-Nr.: 2011-004405-25 / Study code: HIPEC_Stomach) and was initiated in August 2012.
|Study Type :||Interventional (Clinical Trial)|
|Actual Enrollment :||3 participants|
|Intervention Model:||Parallel Assignment|
|Masking:||None (Open Label)|
|Official Title:||Randomized Controlled Trial to Prevent Peritoneal Seeding in Gastric Cancer|
|Study Start Date :||September 2012|
|Actual Primary Completion Date :||May 2015|
|Actual Study Completion Date :||May 2015|
Experimental: positive cytology with HIPEC
gastric cancer cytology positive with HIPEC Mytomycin and cisplatin intraoperative
Drug: positive cytology with HIPEC
HIPEC with mytomycin and cisplatin
Other Name: mytomycin and cisplatin
No Intervention: positive cytology without HIPEC
gastric cancer cytology positive without HIPEC
No Intervention: negative cytology without HIPEC
gastric cancer with negative cytology
- Peritoneal Carcinosis Free Survival [ Time Frame: 5 Years ]Three patients were enrolled in the study. No study results because no patient has received study drug.
- Disease Free Survival [ Time Frame: 5 years ]No study results because no patient has received study drug.
- Procedure Related Complication [ Time Frame: 60 days ]No study results because no patient has received study drug.
- Kinetics of Mitomycin and Cisplatin [ Time Frame: 24 hours after application ]
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01683864
|University of Tuebingen|
|Tuebingen, BW, Germany, 72076|
|Principal Investigator:||Alfred Königsrainer, MD||University Hospital Tuebingen|