Epithelial Ovarian Cancer
Conditions
Keywords
HIPEC, ovarian cancer, peritoneal carcinomatosis
Brief summary
Randomized clinical trial to asses the efficacy of closed abdomen hyperthermia intraperitoneal chemotherapy with paclitaxel in ovarian cancer.
Detailed description
Randomized clinical trial performed in woman with epithelial primary ovarian cancer (stage FIGO II, III and IV) or tumor recurrence. A cytoreductive surgery will be perform in all of the patients include in the trial, and it will be assign at randomization: * HIPEC-arm: cytoreductive surgery and hyperthermic intraperitoneal chemotherapy with paclitaxel (175 mg / m2) for 60 minutes at a temperature of 42-43º degrees; followed by postoperative systemic IV chemotherapy with carboplatin (AUC=6) and paclitaxel (175 mg/m2) for 6 cycles. * No HIPEC-arm: Cytoreductive surgery followed by postoperative systemic IV chemotherapy with carboplatin (AUC=6) and paclitaxel (175 mg/m2) for 6 cycles.
Interventions
DRUGHIPEC
Cytoreductive surgery and Hyperthermic Intraperitoneal Chemotherapy (HIPEC) with Paclitaxel (175 mg/m2) for 60 minutes at 42-43 degrees.
PROCEDURENo HIPEC
Cytoreductive surgery without HIPEC
Sponsors
Hospital General de Ciudad Real
University of Castilla-La Mancha
PEDRO VILLAREJO CAMPOS
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
NONE
Eligibility
Sex/Gender
FEMALE
Age
18 Years to 80 Years
Healthy volunteers
No
Inclusion criteria
* Women with histologically confirmed epithelial ovarian cancer (stage II / III / IV disease of FIGO) or tumor recurrences (the women of childbearing age need to have a negative pregnancy test) * Complete cytoreduction: Index CC0/CC1 cytoreduction (residual tumor size after surgery, no visible (CC0) or less than 0.25 cm (CC1)) * No extra-abdominal tumor disease * Absence of heart failure. Adequate renal and hepatic functions * Eastern Cooperative Oncology Group performance status 0-2 or Karnofsky performance status ≥ 70%
Exclusion criteria
* Patients with unresectable tumor or incomplete cytoreduction. * Contraindications for treatment with paclitaxel: patients with severe hypersensitivity to paclitaxel or any of the excipients,pregnancy or lactation and patients with baseline neutrophil count \<1.500/mm3 (\<1.000/mm3 for patients with Kaposi sarcoma). Paclitaxel is also contraindicated in patients who have concurrent and severe infections. * Extra-abdominal metastases or unresectable liver metastases * Presence of other malignant tumor disease. * Multisegmental complete bowel obstruction. * Patients with severe medical problems that will preclude compliance with the study or with an unacceptable risk * Patients who refuse treatment or consent to participate in study
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Overall survival | every 6 months till 36 months | From the date of surgery to the date of death or to the end of study (follow up every 6 months till 3 years) |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Progression free survival | follow up every 6 months till 18 months | From the date of surgery to the date of recurrence or to the end of study (follow up every 6 months till 18 months) |
Other
| Measure | Time frame | Description |
|---|---|---|
| Post-operative complications | adverse events within 30 days postoperatively (according to NCI criteria, Common Terminology Criteria for AE (CTCAE)) | Compare adverse events between study arms |
Countries
Spain
Contacts
Primary ContactPedro Villarejo Campos, MD,PhD
Outcome results
None listed