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NCT Number: NCT03931304

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

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.

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Key information

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Cytoreductive surgery combined with hyperthermic intraperitoneal chemotherapy procedure

Procedure

Cytoreductive surgery combined with hyperthermic intraperitoneal chemotherapy procedure

Other names: Cytoreductive surgery alone

Primary outcomes

  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

Sponsors and collaborators

Lead sponsor

Hospices Civils de Lyon

Other

Registry information

Official study title

Cytoreductive Surgery and Hyperthermic Intraperitoneal Chemotherapy in Peritoneal Carcinomatosis From Ovarian Cancer

Acronym: Cyto-chip 2

Important dates

Study start
2018
Primary completion
2018
Study completion
2018
First posted
Apr 30, 2019
Registry last updated
Apr 30, 2019

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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