Randomized Controlled Trial to Prevent Peritoneal Seeding in Gastric Cancer (HIPEC_Stomach)

This study is currently recruiting participants. (see Contacts and Locations)
Verified September 2012 by University Hospital Tuebingen
Sponsor:
Information provided by (Responsible Party):
PD Dr. Derek Zieker, University Hospital Tuebingen
ClinicalTrials.gov Identifier:
NCT01683864
First received: September 6, 2012
Last updated: September 11, 2012
Last verified: September 2012
  Purpose

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.


Condition Intervention Phase
Gastric Cancer
Peritoneal Carcinomatosis
Drug: HIPEC with mytomycin and cisplatin
Procedure: Diagnostic laparoscopy one year after gastrectomy
Phase 2
Phase 3

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Parallel Assignment
Masking: Open Label
Primary Purpose: Treatment
Official Title: Randomized Controlled Trial to Prevent Peritoneal Seeding in Gastric Cancer

Resource links provided by NLM:


Further study details as provided by University Hospital Tuebingen:

Primary Outcome Measures:
  • Peritoneal carcinosis free survival [ Time Frame: 5 years ] [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • Disease free Survival [ Time Frame: 5 years ] [ Designated as safety issue: No ]

Other Outcome Measures:
  • procedure related complication [ Time Frame: 60 days ] [ Designated as safety issue: Yes ]
  • kinetics of mitomycin and cisplatin [ Time Frame: 24 hours after application ] [ Designated as safety issue: No ]

Estimated Enrollment: 60
Study Start Date: September 2012
Estimated Study Completion Date: September 2020
Primary Completion Date: September 2012 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
gastric cancer cytology positive without HIPEC Procedure: Diagnostic laparoscopy one year after gastrectomy
for all 3 arms
Experimental: gastric cancer cytology positive with HIPEC
with Mytomycin and cisplatin intraoperative
Drug: HIPEC with mytomycin and cisplatin Procedure: Diagnostic laparoscopy one year after gastrectomy
for all 3 arms
gastric cancer with negative cytology Procedure: Diagnostic laparoscopy one year after gastrectomy
for all 3 arms

  Eligibility

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
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
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01683864

Contacts
Contact: Derek Zieker, MD 0049 15115608160 derek.zieker@med.uni-tuebingen.de
Contact: Sven Müller, MD sven.mueller@med.uni-tuebingen.de

Locations
Germany
University of Tuebingen Recruiting
Tuebingen, BW, Germany, 72076
Contact: Derek Zieker, MD         
Principal Investigator: Alfred Königsrainer, MD         
Principal Investigator: Derek Zieker, MD         
Sponsors and Collaborators
PD Dr. Derek Zieker
Investigators
Principal Investigator: Alfred Königsrainer, MD University Hospital Tuebingen
  More Information

No publications provided

Responsible Party: PD Dr. Derek Zieker, Principal Investigator, University Hospital Tuebingen
ClinicalTrials.gov Identifier: NCT01683864     History of Changes
Other Study ID Numbers: 2011-004405-25
Study First Received: September 6, 2012
Last Updated: September 11, 2012
Health Authority: Germany: Federal Institute for Drugs and Medical Devices

Additional relevant MeSH terms:
Stomach Neoplasms
Gastrointestinal Neoplasms
Digestive System Neoplasms
Neoplasms by Site
Neoplasms
Digestive System Diseases
Gastrointestinal Diseases
Stomach Diseases
Cisplatin
Antineoplastic Agents
Therapeutic Uses
Pharmacologic Actions
Radiation-Sensitizing Agents

ClinicalTrials.gov processed this record on September 18, 2014