Feasibility Study of HIPEC for Patients With Stage III or Only Pleural Stage IV Ovarian Carcinoma in First Line Therapy

Free University of Brussels (ULB)

Status and phase: Completed; Phase 2; Phase 1

Conditions: Primary Peritoneal Carcinoma; Ovarian Carcinoma; Fallopian Tube Carcinoma

Treatments: Procedure: HIPEC

Study type: Interventional

Funder types: Other

Identifiers

NCT01709487

HIPEC

Details and patient eligibility

About

First line treatment for advanced ovarian carcinoma hyperthermic intraperitoneal chemotherapy (HIPEC) after optimal debulking.

Full description

Addition of HIPEC to the standard first line treatment of ovarian carcinoma.

Enrollment: 19 patients

Sex: Female

Ages: 18+ years old

Volunteers: No Healthy Volunteers

Inclusion criteria

• stage III or only pleural stage IV ovarian carcinoma first line treatment

Exclusion criteria

• incomplete surgery poor performance status bad general condition

Trial design

Primary purpose: Treatment

Allocation: N/A

Interventional model: Single Group Assignment

Masking: None (Open label)

---

19 participants in 1 patient group

HIPEC surgery with chemotherapy

Experimental group

Description:

* 3 courses of pre-operative chemotherapy: carboplatin AUC = 5 IV + paclitaxel 175 mg/m2 IV every 3 weeks * Debulking surgery * HIPEC with cisplatin 50 mg/m2 intraperitoneally at the end of surgery * 3 courses of post-operative chemotherapy: carboplatin AUC = 5 IV + paclitaxel 175 mg/m2 IV every 3 weeks

Treatment:

Procedure: HIPEC