Trial | NCT02681432  Report issue

Title

Hyperthermic Intraperitoneal Chemotherapy With Paclitaxel in Advanced Ovarian Cancer
Hyperthermic Intraperitoneal Chemotherapy With Paclitaxel for the Treatment of Patients With Recurrent or Primary Advanced Ovarian Cancer : A Randomised Phase 3 Study

  • Phase

    Phase 3

  • Study Type

    Interventional

  • Status

    Unknown status

  • Intervention/Treatment

    paclitaxel ...

  • Study Participants

    60
Randomized clinical trial to asses the efficacy of closed abdomen hyperthermia intraperitoneal chemotherapy with paclitaxel in ovarian cancer.
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 Started
Jan 31
2012
Primary Completion
Sep 30
2019
Anticipated
Study Completion
Dec 31
2019
Anticipated
Last Update
Aug 21
2018

Drug HIPEC

Cytoreductive surgery and Hyperthermic Intraperitoneal Chemotherapy (HIPEC) with Paclitaxel (175 mg/m2) for 60 minutes at 42-43 degrees.

Procedure No HIPEC

Cytoreductive surgery without HIPEC

HIPEC Experimental

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

No HIPEC Active Comparator

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

Criteria 

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
No Results Posted