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

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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
Sponsor:
Information provided by (Responsible Party):
University Hospital Tuebingen

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

Condition or disease Intervention/treatment Phase
Gastric Cancer Peritoneal Carcinomatosis Drug: positive cytology with HIPEC Phase 2 Phase 3

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.


Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 3 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
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

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Stomach Cancer
Drug Information available for: Cisplatin
U.S. FDA Resources

Arm Intervention/treatment
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



Primary Outcome Measures :
  1. 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.

  2. Disease Free Survival [ Time Frame: 5 years ]
    No study results because no patient has received study drug.


Other Outcome Measures:
  1. Procedure Related Complication [ Time Frame: 60 days ]
    No study results because no patient has received study drug.

  2. Kinetics of Mitomycin and Cisplatin [ Time Frame: 24 hours after application ]


Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years and older   (Adult, Senior)
Sexes Eligible for Study:   All
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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01683864


Locations
Germany
University of Tuebingen
Tuebingen, BW, Germany, 72076
Sponsors and Collaborators
University Hospital Tuebingen
Investigators
Principal Investigator: Alfred Königsrainer, MD University Hospital Tuebingen

Responsible Party: University Hospital Tuebingen
ClinicalTrials.gov Identifier: NCT01683864     History of Changes
Other Study ID Numbers: 2011-004405-25
First Posted: September 12, 2012    Key Record Dates
Results First Posted: January 30, 2018
Last Update Posted: January 30, 2018
Last Verified: October 2016
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

Additional relevant MeSH terms:
Stomach Neoplasms
Carcinoma
Gastrointestinal Neoplasms
Digestive System Neoplasms
Neoplasms by Site
Neoplasms
Digestive System Diseases
Gastrointestinal Diseases
Stomach Diseases
Neoplasms, Glandular and Epithelial
Neoplasms by Histologic Type
Cisplatin
Antineoplastic Agents