Hyperthermic Intraperitoneal Chemotherapy With Paclitaxel in Advanced Ovarian Cancer (hipecova)

PEDRO VILLAREJO CAMPOS

Status and phase: Unknown; Phase 3

Conditions: Epithelial Ovarian Cancer

Treatments: Drug: HIPEC; Procedure: No HIPEC

Study type: Interventional

Funder types: Other

Identifiers

NCT02681432

HGCRCIRU001

Details and patient eligibility

About

Randomized clinical trial to asses the efficacy of closed abdomen hyperthermia intraperitoneal chemotherapy with paclitaxel in ovarian cancer.

Full 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.

Enrollment: 60 estimated patients

Sex: Female

Ages: 18 to 80 years old

Volunteers: No Healthy Volunteers

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

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: None (Open label)

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60 participants in 2 patient groups

HIPEC

Experimental group

Description:

Primary ovarian cancer FIGO stage II, III or IV or recurrent

Treatment:

Drug: HIPEC

No HIPEC

Active Comparator group

Description:

Primary ovarian cancer FIGO stage II, III or IV or recurrent

Treatment:

Procedure: No HIPEC