4006-776-356 出国就医服务电话

免费获得国外相关药品,最快 1 个工作日回馈药物信息

出境医 / 临床实验 / Cytoreductive Surgery and Hyperthermic Intraperitoneal Chemotherapy in Peritoneal Carcinomatosis From Ovarian Cancer (Cyto-chip 2) (Cyto-chip 2)

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

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 Intervention/treatment
Peritoneal Carcinoma Ovarian Cancer Procedure: Cytoreductive surgery combined with hyperthermic intraperitoneal chemotherapy procedure

Study Design
Layout table for study information
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 1, 2018
Actual Primary Completion Date : July 31, 2018
Actual Study Completion Date : September 30, 2018
Arms and Interventions
Group/Cohort 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
Other Name: Cytoreductive surgery alone

Control group
Cytoreductive surgery alone
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
Layout table for eligibility information
Ages Eligible for Study:   18 Years 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

Locations
Layout table for location information
France
Centre Hospitalier Lyon Sud
Pierre-Bénite, France, 69495
Sponsors and Collaborators
Hospices Civils de Lyon
Tracking Information
First Submitted Date October 10, 2018
First Posted Date April 30, 2019
Last Update Posted Date April 30, 2019
Actual Study Start Date February 1, 2018
Actual Primary Completion Date July 31, 2018   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures
 (submitted: April 26, 2019)
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
Original Primary Outcome Measures Same as current
Change History No Changes Posted
Current Secondary Outcome Measures Not Provided
Original Secondary Outcome Measures Not Provided
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title Cytoreductive Surgery and Hyperthermic Intraperitoneal Chemotherapy in Peritoneal Carcinomatosis From Ovarian Cancer (Cyto-chip 2)
Official Title Cytoreductive Surgery and Hyperthermic Intraperitoneal Chemotherapy in Peritoneal Carcinomatosis From Ovarian Cancer
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.
Detailed Description Not Provided
Study Type Observational
Study Design Observational Model: Case-Control
Time Perspective: Retrospective
Target Follow-Up Duration Not Provided
Biospecimen Not Provided
Sampling Method Non-Probability Sample
Study Population Patients with ovarian peritoneal metastases.
Condition
  • Peritoneal Carcinoma
  • Ovarian Cancer
Intervention Procedure: Cytoreductive surgery combined with hyperthermic intraperitoneal chemotherapy procedure
Cytoreductive surgery combined with hyperthermic intraperitoneal chemotherapy procedure
Other Name: Cytoreductive surgery alone
Study Groups/Cohorts
  • Cases group
    Cytoreductive surgery combined with hyperthermic intraperitoneal chemotherapy procedure
    Intervention: Procedure: Cytoreductive surgery combined with hyperthermic intraperitoneal chemotherapy procedure
  • Control group
    Cytoreductive surgery alone
Publications * Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status Completed
Actual Enrollment
 (submitted: April 26, 2019)
1200
Original Actual Enrollment Same as current
Actual Study Completion Date September 30, 2018
Actual Primary Completion Date July 31, 2018   (Final data collection date for primary outcome measure)
Eligibility 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
Sex/Gender
Sexes Eligible for Study: Female
Ages 18 Years to 95 Years   (Adult, Older Adult)
Accepts Healthy Volunteers No
Contacts Contact information is only displayed when the study is recruiting subjects
Listed Location Countries France
Removed Location Countries  
 
Administrative Information
NCT Number NCT03931304
Other Study ID Numbers Cyto-chip 2
Has Data Monitoring Committee No
U.S. FDA-regulated Product
Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
IPD Sharing Statement
Plan to Share IPD: No
Responsible Party Hospices Civils de Lyon
Study Sponsor Hospices Civils de Lyon
Collaborators Not Provided
Investigators Not Provided
PRS Account Hospices Civils de Lyon
Verification Date October 2018

治疗医院