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

NCT ID: NCT03931304

Last Updated: 2019-04-30

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Total Enrollment

1200 participants

Study Classification

OBSERVATIONAL

Study Start Date

2018-02-01

Study Completion Date

2018-09-30

Brief Summary

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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.

Detailed Description

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Conditions

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Peritoneal Carcinoma Ovarian Cancer

Study Design

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Observational Model Type

CASE_CONTROL

Study Time Perspective

RETROSPECTIVE

Study Groups

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Cases group

Cytoreductive surgery combined with hyperthermic intraperitoneal chemotherapy procedure

Cytoreductive surgery combined with hyperthermic intraperitoneal chemotherapy procedure

Intervention Type PROCEDURE

Cytoreductive surgery combined with hyperthermic intraperitoneal chemotherapy procedure

Control group

Cytoreductive surgery alone

No interventions assigned to this group

Interventions

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Cytoreductive surgery combined with hyperthermic intraperitoneal chemotherapy procedure

Cytoreductive surgery combined with hyperthermic intraperitoneal chemotherapy procedure

Intervention Type PROCEDURE

Other Intervention Names

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Cytoreductive surgery alone

Eligibility Criteria

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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
Minimum Eligible Age

18 Years

Maximum Eligible Age

95 Years

Eligible Sex

FEMALE

Accepts Healthy Volunteers

No

Sponsors

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Hospices Civils de Lyon

OTHER

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Locations

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Centre Hospitalier Lyon Sud

Pierre-Bénite, , France

Site Status

Countries

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France

Other Identifiers

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Cyto-chip 2

Identifier Type: -

Identifier Source: org_study_id