Randomized Controlled Trial to Prevent Peritoneal Seeding in Gastric Cancer

NCT ID: NCT01683864

Last Updated: 2018-01-30

Basic Information

• Recruitment Status: TERMINATED
• Clinical Phase: PHASE2/PHASE3
• Total Enrollment: 3 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2012-09-30
• Study Completion Date: 2015-05-31

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.

Conditions

Gastric Cancer; Peritoneal Carcinomatosis

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: NONE

Study Groups

positive cytology with HIPEC

gastric cancer cytology positive with HIPEC Mytomycin and cisplatin intraoperative

Group Type: EXPERIMENTAL

positive cytology with HIPEC

Intervention Type: DRUG

HIPEC with mytomycin and cisplatin

positive cytology without HIPEC

gastric cancer cytology positive without HIPEC

Group Type: NO_INTERVENTION

No interventions assigned to this group

negative cytology without HIPEC

gastric cancer with negative cytology

Group Type: NO_INTERVENTION

No interventions assigned to this group

Interventions

positive cytology with HIPEC

HIPEC with mytomycin and cisplatin

Intervention Type: DRUG

Other Intervention Names

mytomycin and cisplatin

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

• Minimum Eligible Age: 18 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

University Hospital Tuebingen

OTHER

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Alfred Königsrainer, MD

Role: PRINCIPAL_INVESTIGATOR

University Hospital Tuebingen

Locations

University of Tuebingen

Tübingen, Baden-Wurttemberg, Germany

Countries

Germany

Other Identifiers

2011-004405-25

Identifier Type: -

Identifier Source: org_study_id