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Clinical Trials/EUCTR2009-009467-59-BE
EUCTR2009-009467-59-BE
Active, not recruiting
Not Applicable

Feasibility study of hyperthermic intraperitoneal chemotherapy (HIPEC) for patients with stage III or only pleural stage IV ovarian carcinoma in first line therapy. - HIPEC-ovarian carcinoma

Institut Jules Bordet0 sitesJanuary 20, 2010
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ConditionsInclusion criteria :1. Histologically confirmed ovarian carcinoma or primary peritoneal carcinoma or Fallopian tube carcinoma.2. FIGO stage III disease or only pleural stage IV disease3. Age less than 65 years4. ECOG performance status 0-1.5. Adequate bone marrow, hepatic and renal functions.6. No serious cardiac or respiratory illness
DrugsPlatosin

Overview

Phase
Not Applicable
Intervention
Not specified
Conditions
Inclusion criteria :1. Histologically confirmed ovarian carcinoma or primary peritoneal carcinoma or Fallopian tube carcinoma.2. FIGO stage III disease or only pleural stage IV disease3. Age less than 65 years4. ECOG performance status 0-1.5. Adequate bone marrow, hepatic and renal functions.6. No serious cardiac or respiratory illness
Sponsor
Institut Jules Bordet
Status
Active, not recruiting
Last Updated
10 years ago
OverviewInvestigatorsEligibility CriteriaOutcomesSimilar Trials

Overview

Brief Summary

No summary available.

Registry
who.int
Start Date
January 20, 2010
End Date
TBD
Last Updated
10 years ago
Study Type
Interventional clinical trial of medicinal product
Sex
Female

Investigators

Sponsor
Institut Jules Bordet

Eligibility Criteria

Inclusion Criteria

  • •1\. Histologically confirmed ovarian carcinoma or primary peritoneal carcinoma or Fallopian tube carcinoma.
  • •2\. FIGO stage III disease or only pleural stage IV disease
  • •3\. Age less than 65 years
  • •4\. ECOG performance status 0\-1\.
  • •5\. Adequate bone marrow, hepatic and renal functions.
  • •6\. No serious cardiac or respiratory illness
  • •7\. No major co morbidity such as diabetes or other condition that might hamper the postoperative recuperation.
  • •8\. preoperative chemotherapy with carboplatinum\-paclitaxel is recommended for lower surgical morbidity (3 courses).
  • •9\. PCI (peritoneal carcinomatosis index) score \< 21
  • •Are the trial subjects under 18? no

Exclusion Criteria

  • •1\. metastatic disease in other sites than pleural
  • •2\. age higher than 65 years
  • •3\. ECOG PS 2 or higher
  • •4\. serious cardiac or respiratory illness
  • •5\. major co morbidity
  • •6\. impaired bone marrow, hepatic and renal functions
  • •7\. PCI score equal or higher than 21

Outcomes

Primary Outcomes

Not specified

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