HOT: HIPEC in Ovarian Cancer as Initial Treatment

Summary

Community hospital based phase II (prospective randomized) study to evaluate the toxicity of cytoreductive surgery (CRS) and hyperthermic intraperitoneal chemotherapy (HIPEC) in newly diagnosed, otherwise untreated, advanced stage (stage III/IV) epithelial ovarian, fallopian tube, and primary peritoneal cancer.

Conditions

• Stage III Ovarian Cancer
• Stage IV Ovarian Cancer
• Epithelial Ovarian Cancer
• Fallopian Tube Cancer
• Primary Peritoneal Carcinoma
• Ovarian Carcinoma
• Fallopian Tube Carcinoma

Interventions

PROCEDURE

Cytoreductive Surgery (CRS)

Cytoreductive surgery

DRUG

Adjuvant Chemotherapy

Six weeks post-surgery (CRS or CRS/HIPEC) standard combination chemotherapy will be administered every 21 days for 6 cycles

OTHER

Questionnaire

Questionnaires designed to assess quality of life in ovarian cancer patients will be administered to study participants

PROCEDURE

Hyperthermic intraperitoneal chemotherapy

Hyperthermic intraperitoneal chemotherapy with carboplatin, AUC=6

DRUG

Carboplatin

AUC=6 mg/mL/min IV (in the vein), on day 1. Repeat every 21 days for 6 cycles.

DRUG

Paclitaxel

175 mg/m2 IV (in the vein), day 1. Repeat every 21 days for 6 cycles

DRUG

Paclitaxel

Day 1: paclitaxel 135 mg/m2 IV (in the vein). Repeat every 21 days for 6 cycles Day 8: paclitaxel 60 mg/m2 IP (intraperitoneal). Repeat every 21 days for 6 cycles

DRUG

Cisplatin

Day 2: cisplatin 75 mg/m2 IP (intraperitoneal). Repeat every 21 days for 6 cycles

Sponsors & Collaborators

• Mercy Medical Center

  lead OTHER

Principal Investigators

• Teresa Diaz-Montes, M.D. · Mercy Medical Center

• Armando Sardi, M.D. · Mercy Medical Center

Study Design

Allocation

RANDOMIZED

Purpose

TREATMENT

Masking

NONE

Model

PARALLEL

Eligibility

Min Age

18 Years

Max Age

80 Years

Sex

FEMALE

Healthy Volunteers

No

Timeline & Regulatory

Start

2014-04-30

Primary Completion

2027-08-31

Completion

2028-04-30

Countries

• United States

Study Locations