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Currently, you can access the following clinical trials being conducted worldwide:

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Clinical trial information and results are updated daily from ClinicalTrials.gov. The latest data update was conducted on 06/15/2021.
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Clinical trial information and results are updated daily from ClinicalTrials.gov. The latest data update was conducted on 06/15/2021.

Cytoreductive Surgery and Hyperthermic Intraperitoneal Chemotherapy in Peritoneal Carcinomatosis From Ovarian Cancer (Cyto-chip 2)

Clinicaltrials.gov identifier NCT03931304

Recruitment Status Completed

First Posted April 30, 2019

Last update posted April 30, 2019

Study Description

Brief summary:

Epithelial ovarian carcinoma (EOC) is one of the main cause of death from cancer in women in the Western world. It is often diagnosed at an advanced stage and the disease remains confined to the peritoneal cavity for much of its natural history. Despite a high rate of response to first-line therapy, about 20% of EOC are naturally resistant to platinum and about 2/3 of patients with initial response will recur within 5 years. Most tumour recurrences will develop resistance to systemic platinum over time. The prognosis of these patients with persistent or recurrence disease remains poor despite salvage therapy including alternative systemic chemotherapy and further cytoreductive surgery (CRS). Since twenty years, centers have pursued comprehensive CRS combined with Hyperthermic Intraperitoneal Chemotherapy (HIPEC) for the management of peritoneal surface malignancies (PSM). This combined approach is the standard of care for the management of some rare peritoneal disease such as pseudomyxoma peritonei or peritoneal mesothelioma. EOC should be an ideal target for this loco-regional treatment, as most of its evolution remains confined to intraperitoneal cavity and because of its sensitivity to chemotherapy. Intraperitoneal chemotherapy has been shown to have significant efficacy in frontline EOC in 3 large randomized studies. Recently, French clinical guidelines have been edited to recommend CRS+HIPEC in patients with ovarian, tubal or primitive carcinomatosis FIGOI IIIC, initially not resectable (Grade B). HIPEC adds some advantages to this intraperitoneal chemotherapy: the hyperthermia effect with its direct cytotoxicity demonstrated in vitro, the synergistic effect with some anticancer agents and, the deliverance immediately following CRS, avoiding the problem of "cancer cell entrapment" by postoperative or posttherapeutic adhesions that limits distribution of chemotherapy agents to all sites. The use of HIPEC for EOC was reported into relatively small case-series from single institutions. Results from a single centre cannot be extrapolated to other centres because of the heterogeneity of patient's selection and HIPEC techniques.

  • Condition or Disease:Peritoneal Carcinoma
    Ovarian Cancer
  • Intervention/Treatment: Procedure: Cytoreductive surgery combined with hyperthermic intraperitoneal chemotherapy procedure
  • Phase: N/A
Detailed Description

N/A

Study Design
  • Study Type: Observational
  • Actual Enrollment: 1200 participants
  • Observational Model: Case-Control
  • Time Perspective: Retrospective
  • Official Title: Cytoreductive Surgery and Hyperthermic Intraperitoneal Chemotherapy in Peritoneal Carcinomatosis From Ovarian Cancer
  • Actual Study Start Date: February 2018
  • Actual Primary Completion Date: July 2018
  • Actual Study Completion Date: September 2018
Groups and Cohorts
Groups/Cohorts Intervention/treatment
: Cases group
Cytoreductive surgery combined with hyperthermic intraperitoneal chemotherapy procedure
Procedure: Cytoreductive surgery combined with hyperthermic intraperitoneal chemotherapy procedure
Cytoreductive surgery combined with hyperthermic intraperitoneal chemotherapy procedure
Outcome Measures
  • Primary Outcome Measures: 1. Evaluation of 3-years disease free survival [ Time Frame: 3 years ]
    From the date of cytoreductive surgery with Hyperthermic Intraperitoneal Chemotherapy to death or to the end of follow-up
Eligibility Criteria
  • Ages Eligible for Study: 18 to 95 Years (Adult, Older Adult)
  • Sexes Eligible for Study: Female
  • Accepts Healthy Volunteers: No
  • Sampling Method: Non-Probability Sample
  • Study Population: Patients with ovarian peritoneal metastases.
Criteria

Inclusion Criteria:

- Confirmed peritoneal carcinomatosis from ovarian cancer

- Metachronous/synchronous peritoneal carcinomatosis

- Grade FIGO (International Federation of Gynecology and Obstetrics) III or IV

- Peritoneal Cancer Index (PCI) available

- Indication for cytoreductive surgery +/- HIPEC

- Complete macroscopic cytoreduction: CCR (cytoreduction score) -0/1

Exclusion Criteria:

- Non complete macroscopic cytoreduction: CCR (cytoreduction score) -2

- Peritoneal mesothelioma, pseudomyxoma peritonei

- Extra peritoneal metastases

Contacts and Locations
Contacts
Locations

France
Centre Hospitalier Lyon Sud
Pierre-Bénite

Sponsors and Collaborators

Hospices Civils de Lyon

More Information
  • Responsible Party: Hospices Civils de Lyon
  • ClinicalTrials.gov Identifier: NCT03931304 History of Changes
  • Other Study ID Numbers: Cyto-chip 2
  • First Posted: April 30, 2019 Key Record Dates
  • Last Update Posted: April 30, 2019
  • Last Verified: October 2018
  • Individual Participant
    Data (IPD) Sharing
    Statement:
  • Plan to Share IPD: No
  • Studies a U.S. FDA-regulated Drug Product: No
  • Studies a U.S. FDA-regulated Device Product: No
  • Additional relevant MeSH terms: Carcinoma
    Peritoneal Neoplasms
    Ovarian Neoplasms
    Carcinoma, Ovarian Epithelial