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NCT number NCT01970722
Study type Interventional
Source City of Hope Medical Center
Contact Kathleen Kelly
Phone 626 256-4673
Email kkelly@coh.org
Status Recruiting
Phase N/A
Start date May 2014
Completion date May 2020

Clinical Trial Summary

This clinical trial studies the side effects and how well surgery and heated chemotherapy with or without non-heated chemotherapy after surgery works in treating patients with ovarian, fallopian tube, uterine, or peritoneal cancer. Giving a dose of heated chemotherapy into the abdomen during surgery that is done to remove ovarian, fallopian tube, uterine, or peritoneal cancer may help lower the risk of the cancer coming back. Giving unheated chemotherapy drugs directly into the abdomen after surgery may kill more tumor cells.


Clinical Trial Description

PRIMARY OBJECTIVES:

I. To determine whether cytoreductive surgery with hyperthermic intraperitoneal chemotherapy (HIPEC) followed by postoperative normothermic intraperitoneal (IP) chemotherapy is feasible and safe to administer, as measured by toxicities occurring during treatment or follow-up.

SECONDARY OBJECTIVES:

I. To determine quality of life (QoL) and compare the outcomes to a historical control of IP chemotherapy (no HIPEC) for women with ovarian cancer.

II. To determine whether cytoreductive surgery with HIPEC alone is feasible and safe to administer, as measured by toxicities occurring during treatment or follow-up.

III. To estimate progression-free survival (PFS).

IV. To collect biospecimens and perform correlative translational studies focused on understanding the mechanisms of action of HIPEC on ovarian cancer and micro ribonucleic acid (RNA) profiling of ovarian cancer and ex vivo evaluation of oncolytic virus replication.

OUTLINE: Patients undergo surgery and receive hyperthermic cisplatin intraperitoneally (IP) over 60 minutes. Beginning at least 3 weeks after surgery, patients may receive carboplatin, paclitaxel, pegylated liposomal doxorubicin hydrochloride, or gemcitabine hydrochloride IP or intravenously (IV) at the discretion of the medical and gynecologic oncologists.

After completion of study treatment, patients are followed up at 3-6, 6-9, 9-12, and 12-15 months; every 3 months for 1 year; and then every 4 months for 1 year.


Study Design


Related Conditions & MeSH terms

  • Fallopian Tube Neoplasms
  • Ovarian Neoplasms
  • Peritoneal Neoplasms
  • Recurrent Fallopian Tube Cancer
  • Recurrent Ovarian Cancer
  • Recurrent Primary Peritoneal Cancer
  • Recurrent Uterine Corpus Cancer
  • Stage IIIA Fallopian Tube Cancer
  • Stage IIIA Ovarian Cancer
  • Stage IIIA Primary Peritoneal Cavity Cancer
  • Stage IIIA Uterine Corpus Cancer
  • Stage IIIB Fallopian Tube Cancer
  • Stage IIIB Ovarian Cancer
  • Stage IIIB Primary Peritoneal Cavity Cancer
  • Stage IIIB Uterine Corpus Cancer
  • Stage IIIC Fallopian Tube Cancer
  • Stage IIIC Ovarian Cancer
  • Stage IIIC Primary Peritoneal Cavity Cancer
  • Stage IIIC Uterine Corpus Cancer
  • Stage IV Fallopian Tube Cancer
  • Stage IV Ovarian Cancer
  • Stage IV Primary Peritoneal Cavity Cancer
  • Stage IVA Uterine Corpus Cancer
  • Stage IVB Uterine Corpus Cancer
  • Uterine Neoplasms

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