Randomized Controlled Trial to Prevent Peritoneal Seeding in Gastric Cancer

NCT01683864 | Terminated Phase 2 Results DMC

• 1 other identifier: 2011-004405-25
• Study Type: interventional
• Target: 3
• Locations: 1 country
• Sites: 1

Brief Summary

Randomized Controlled Trial to Prevent Peritoneal Seeding in Gastric Cancer

Conditions

Gastric Cancer; Peritoneal Carcinomatosis

Outcome Measures

Primary Outcomes (2)

• Peritoneal Carcinosis Free Survival

  Three patients were enrolled in the study. No study results because no patient has received study drug.

  5 Years

• Disease Free Survival

  No study results because no patient has received study drug.

  5 years

Other Outcomes (2)

• Procedure Related Complication

  60 days

• Kinetics of Mitomycin and Cisplatin

  24 hours after application

Study Arms (3)

positive cytology with HIPEC

EXPERIMENTAL

gastric cancer cytology positive with HIPEC Mytomycin and cisplatin intraoperative

Drug: positive cytology with HIPEC

positive cytology without HIPEC

NO INTERVENTION

gastric cancer cytology positive without HIPEC

negative cytology without HIPEC

NO INTERVENTION

gastric cancer with negative cytology

Interventions

positive cytology with HIPEC DRUG

HIPEC with mytomycin and cisplatin

Also known as: mytomycin and cisplatin

positive cytology with HIPEC

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

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

You may not qualify if:

• Dissemination of the tumor or non-resectable primary tumor
• Malignant secondary disease \< 5 years in the past (Exception: in-situ-carcinoma of the cervix and appropriately treated basal cell carcinoma of the skin)
• Patient not of full age
• Inflammatory chronic bowel disease
• Pregnancy or lactation

Sponsors & Collaborators

• University Hospital Tuebingen: lead

Study Sites (1)

University of Tuebingen

Tübingen, Baden-Wurttemberg, 72076, Germany

Location

MeSH Terms

Conditions

Stomach Neoplasms; Peritoneal Neoplasms

Interventions

Hyperthermic Intraperitoneal Chemotherapy; Cisplatin

Condition Hierarchy (Ancestors)

Gastrointestinal Neoplasms; Digestive System Neoplasms; Neoplasms by Site; Neoplasms; Digestive System Diseases; Gastrointestinal Diseases; Stomach Diseases; Abdominal Neoplasms; Peritoneal Diseases

Intervention Hierarchy (Ancestors)

Chemotherapy, Adjuvant; Combined Modality Therapy; Therapeutics; Drug Therapy; Hyperthermia, Induced; Chlorine Compounds; Inorganic Chemicals; Nitrogen Compounds; Platinum Compounds

Results Point of Contact

• Title: Prof. Alfred Königsrainer
• Organization: University Clinic of Tübingen

silvia.wagner@med.uni-tuebingen.de

0049 7071 2983290

Study Officials

• Alfred Königsrainer, MD

  University Hospital Tuebingen

  PRINCIPAL INVESTIGATOR

Publication Agreements

• PI is Sponsor Employee: Yes

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: September 6, 2012
• First Posted: September 12, 2012
• Study Start: September 1, 2012
• Primary Completion: May 1, 2015
• Study Completion: May 1, 2015
• Last Updated: January 30, 2018
• Results First Posted: January 30, 2018

Record last verified: 2016-10

Data Sharing

• IPD Sharing: Will not share

Locations

DE (1)