Clinical trial NCT01683864: Randomized Controlled Trial to Prevent Peritoneal Seeding in Gastric Cancer
Official title: Randomized Controlled Trial to Prevent Peritoneal Seeding in Gastric Cancer
Study type: INTERVENTIONAL
Overall status: TERMINATED
Phase: PHASE2
PHASE3
Conditions: Gastric Cancer
Peritoneal Carcinomatosis
Lead sponsor: University Hospital Tuebingen
Sponsor class: OTHER
First posted: 2012-09-12
Enrollment: 3
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: Randomized Controlled Trial to Prevent Peritoneal Seeding in Gastric Cancer

Detailed description: 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.

Eligibility criteria: Inclusion Criteria:

1. Histologically proven gastric adenocarcinoma: uT1,uT2, uT3, Nx, M0
2. No prior chemotherapy
3. Patients of full age, independent of gender ECOG ≤ 2
4. No dissemination of the tumor confirmed by CT of the lung and the abdomen.
5. Signed Consent form of the Patient agreeing to investigations
6. Leucocytes \> 3.000/µl
7. Thrombocytes \> 100.000/µl
8. Creatinine ≤ 1.5mg/dl and or Clearance \> 60 ml/min
9. informed consent of the patient
10. normal ejection-fraction of the heart

Exclusion Criteria:

1. Dissemination of the tumor or non-resectable primary tumor
2. Malignant secondary disease \< 5 years in the past (Exception: in-situ-carcinoma of the cervix and appropriately treated basal cell carcinoma of the skin)
3. Patient not of full age
4. Inflammatory chronic bowel disease
5. Inclusion of the patient in a different study
6. Pregnancy or lactation

Primary outcomes:
measure: Peritoneal Carcinosis Free Survival
timeFrame: 5 Years
measure: Disease Free Survival
timeFrame: 5 years
Secondary outcomes:
Other outcomes:
measure: Procedure Related Complication
timeFrame: 60 days
measure: Kinetics of Mitomycin and Cisplatin
timeFrame: 24 hours after application
Locations:
city: Tuebingen
country: Germany
facility: University of Tuebingen
state: BW
Study officials:
affiliation: University Hospital Tuebingen
name: Alfred Königsrainer, MD
role: PRINCIPAL_INVESTIGATOR
References: