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CompletedNCT03931304Cyto-chip 2Updated Apr 30, 2019

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

An observational study in Peritoneal Carcinoma and Ovarian Cancer, sponsored by Hospices Civils de Lyon. Completed at 1 site in France. Open to female participants aged 18 Years to 95 Years. Per ClinicalTrials.gov, last updated 2019-04-30.

Sponsored by Hospices Civils de Lyon · Observational

Study type
Observational
Model
Case-control
Time perspective
Retrospective
Enrollment
1,200
Ages
18 Years to 95 Years
Sex
Female
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Study 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.

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Conditions studied

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In context

Ovarian Neoplasms

2,695 studies on the registry are indexed under Ovarian Neoplasms; 727 are open to participants now.

This study's enrollment of 1,200 is above the median of 200 across 527 observational studies indexed under Ovarian Neoplasms.

Browse Ovarian Neoplasms studies →

Lead sponsor

Hospices Civils de Lyon is the lead sponsor of 1,826 studies on the registry; 439 are open to participants now.

Counted across the registry records on this site, refreshed daily.

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Who can participate

Ages eligible
18 Years to 95 Years
Sexes eligible
Female
Accepts healthy volunteers
No
Sampling method
Non-probability sample

Study population

Patients with ovarian peritoneal metastases.

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

Exclusion Criteria:

  • Non complete macroscopic cytoreduction: CCR (cytoreduction score) -2
  • Peritoneal mesothelioma, pseudomyxoma peritonei
  • Extra peritoneal metastases
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Study design

Observational model
Case-control
Time perspective
Retrospective
Enrollment
1,200 participants (actual)
Patient registry
No

Groups and cohorts

  • Cases group

    Cytoreductive surgery combined with hyperthermic intraperitoneal chemotherapy procedure

    Procedure: Cytoreductive surgery combined with hyperthermic intraperitoneal chemotherapy procedure

  • Control group

    Cytoreductive surgery alone

Interventions

  • ProcedureCytoreductive surgery combined with hyperthermic intraperitoneal chemotherapy procedure

    Cytoreductive surgery combined with hyperthermic intraperitoneal chemotherapy procedure

    Also known as: Cytoreductive surgery alone

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What researchers measure

Primary outcomes

  1. Evaluation of 3-years disease free survival

    From the date of cytoreductive surgery with Hyperthermic Intraperitoneal Chemotherapy to death or to the end of follow-up

    Time frame: 3 years

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Study locations

1 site
  • Centre Hospitalier Lyon Sud
    Pierre-Bénite, 69495, France
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References and documents

Individual participant data

Plan to share: No

No publications or documents are linked to this record.

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Updates

Tracking since Sep 25, 2026
No changes since tracking began. The registry record was last updated on Apr 30, 2019, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
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Registry details

Key details

Study ID
NCT03931304
Lead sponsor
Hospices Civils de Lyon
Responsible party
Sponsor
First posted
Apr 30, 2019
Start date
Feb 1, 2018
Primary completion
Jul 31, 2018
Completion
Sep 30, 2018
Last update
Apr 30, 2019

Oversight

Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
No
View the source record on ClinicalTrials.gov ↗

Not currently enrolling

This study is completed, as verified in Oct 2018. You cannot join it, but the record below documents what was studied.

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