Hyperthermic Intraperitoneal Chemotherapy With Paclitaxel in Advanced Ovarian Cancer

Phase 3

• Conditions: Epithelial Ovarian Cancer
• Interventions: Procedure: No HIPEC; Drug: HIPEC

• Registration Number: NCT02681432
• Lead Sponsor: PEDRO VILLAREJO CAMPOS

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.

Study Timeline

• Study Start: 2012-01
• Study First Submitted: 2016-01-25
• Study First Submitted QC: 2016-02-11
• Study First Posted: 2016-02-12
• Status Verified: 2018-08
• Last Update Submitted: 2018-08-17
• Last Update Posted: 2018-08-21
• Primary Completion: 2019-09
• Study Completion: 2019-12

Recruitment & Eligibility

• Status: UNKNOWN
• Sex: Female
• Target Recruitment: 60

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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
No HIPEC	No HIPEC	Primary ovarian cancer FIGO stage II, III or IV or recurrent
HIPEC	HIPEC	Primary ovarian cancer FIGO stage II, III or IV or recurrent

Primary Outcome Measures

Name	Time	Method
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 Outcome Measures

Name	Time	Method
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)

Trial Locations

Locations (1)

Hospital General Ciudad Real; 🇪🇸 Ciudad Real, Spain