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ACTIVE NOT RECRUITING
NCT02124421
PHASE2

HOT: HIPEC in Ovarian Cancer as Initial Treatment

Sponsor: Mercy Medical Center

View on ClinicalTrials.gov

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.

Official title: Phase II Randomized Study: Cytoreductive Surgery (CRS) With/Without Carboplatin Hyperthermic Intraperitoneal Chemotherapy (HIPEC) Followed by Adjuvant Chemotherapy as Initial Treatment of Ovarian, Fallopian Tube, & Primary Peritoneal Cancer

Key Details

Gender

FEMALE

Age Range

18 Years - 80 Years

Study Type

INTERVENTIONAL

Enrollment

32

Start Date

2014-04

Completion Date

2028-04

Last Updated

2024-11-19

Healthy Volunteers

No

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

Locations (1)

Mercy Medical Center

Baltimore, Maryland, United States