HIPEC in Ovarian Cancer, Case-Controls Study With 10-year... | NCT04234243

Studies
HIPEC in Ovarian Cancer, Case-Controls Study With 10-years Follow up

NCT04234243

Sponsor

Instituto de Seguridad Social del Estado de Mexico y Municipios

Status

Completed

Last Update Posted

Jan 29, 2020Actual

Enrollment

144Actual

Phase

Not provided

Conditions

Ovarian Cancer
HIPEC

Interventions

cytoreduction and HIPEC

Countries

Not provided

Protocol Section

Identification Module Status Module Sponsor/Collaborators Module Oversight Module Description Module Conditions Module Design Module Arms/Interventions Module Outcomes Module Eligibility Module Contacts/Locations Module References Module IPD Sharing Statement Module

Results Section

Participant Flow Module Baseline Characteristics Module Outcome Measures Module Adverse Events Module More Info Module

Annotation Section

Annotation Module

Document Section

Large Document Module

Derived Section

Miscellaneous Info Module Condition Browse Module Intervention Browse Module

Protocol Section

Identification Module

NCT ID

Results Section

No data available

No data is available for this block.

Annotation Section

No data available

No data is available for this block.

Document Section

No data available

No data is available for this block.

Derived Section

Miscellaneous Info Module

Version Holder

Status Module

Record Verification Date

Jan 2020

Overall Recruitment Status or Expanded Access Status

Completed

Last Known Status

Not provided

Delayed Posting

Not provided

Why Stopped

Not provided

Expanded Access Info

Start Date

Aug 1, 2007Actual

Primary Completion Date

Dec 31, 2017Actual

Completion Date

Aug 31, 2019Actual

First Submitted Date

Jan 10, 2020

First Submission Date that Met QC Criteria

Jan 15, 2020

First Posted Date

Jan 21, 2020Actual

Results Waived

Not provided

Results First Submitted Date

Not provided

Results First Submitted that Met QC Criteria

Not provided

Results First Posted Date

Not provided

Certification/Extension (aka Delayed Results) First Submitted Date

Not provided

Certification/Extension First Submitted that Passed QC Review

Not provided

Certification/Extension First Posted Date

Not provided

Last Update Submitted Date

Jan 27, 2020

Last Update Posted Date

Jan 29, 2020Actual

Sponsor/Collaborators Module

Responsible Party, by Official Title

Juan Manuel Medina Castro, Peritoneal Malignacy neoplasm coordinator, Instituto de Seguridad Social del Estado de Mexico y MunicipiosPrincipal Investigator

Lead Sponsor

Instituto de Seguridad Social del Estado de Mexico y MunicipiosOTHER_GOV

Collaborators

Not provided

Oversight Module

Has Data Monitoring Committee (DMC)

Yes

Is FDA Regulated Drug

Is FDA Regulated Device

Is Unapproved Device

Not provided

Pediatric Postmarket Surveillance of a Device Product

Not provided

Product Exported from US

Not provided

FDAAA801 Violation

Not provided

Description Module

Brief Summary

Objectives:

Compare overall survival (OS) and progression-free survival (PFS) among ovarian cancer patients who underwent into cytoreduction and HIPEC procedure vs patients who only received systemic chemotherapy in a 10-years follow up of a case-control study

Methods:

Cases were defined as patients treated by cytoreduction and HIPEC, and were matched (1:2) with patients treated with chemotherapy only, defined as controls. PFS and OS in the two groups were measured and compared. PFS was calculated from initiation of treatment to progression, death or to the last known follow-up. OS was calculated from initiation of treatment to death or to the last known follow-up.

Detailed Description

Epithelial ovarian cancer has the highest mortality of all gynecologic tumors in the world wide. Patients are diagnosed with International Federation of Gynecology and Obstetrics (FIGO) stage III to IV disease in 75%. The 10-year survival of women with advanced-stage ovarian cancer is 10% to 15% and has not improve in the past 20 years. Despite treatment with maximal cytoreductive surgery (CRS) and platinum-based chemotherapy, approximately 70% of patients with advanced-stage disease relapse within 18 months. Given this high number of recurrences, new approaches are needed to improve outcomes for these patients. Historically, peritoneal carcinomatosis represents a devastating form of cancer progression with a very poor prognosis.

Objectives:

Methods:

Design Module

Study Type

Observational

Number of References to an Expanded Access Study

Not provided

Expanded Access Types

Not provided

Patient Registry

Target Follow-Up Duration

Not provided

Phases

Not provided

Interventional Study Design

Allocation

Not provided

Intervention Model

Biospecimen

No data available

No data is available for this block.

Enrollment

144Actual

Arms/Interventions Module

Arm Groups

Label	Type	Description	Intervention Names
HIPEC		women, with ovarian cancer stage III-IV or recurrent with carcinomatosis treated with cytoreduction and HIPEC	Procedure: cytoreduction and HIPEC
No HIPEC		women, with ovarian cancer stage III-IV or recurrent with carcinomatosis, treated with systemic chemotherapy only

Interventions

Name	Type	Description	Arm Group Labels	Other Names
cytoreduction and HIPEC	Procedure	cytoreduction CCR 0-1, and HIPEC close technique	HIPEC

Outcomes Module

Primary Outcomes

Measure	Description	Time Frame
free overall survival	survillance from HIPEC procedure/IV chemotherapy for carcinomatosis, to death date or last consultation (months) Kaplan Meier curve	10 years
free recurrence survival	survillance from HIPEC procedure/IV chemotherapy for carcinomatosis, to recurrence date (months) Kaplan Meier curve	10 years

Secondary Outcomes

Measure	Description	Time Frame
factors associated with survival	histological and clinical factors associated with survival. uni and multivariate analysis (X2, Cox, U Mann-Witney)	10 years

Other Outcomes

Not provided

Eligibility Module

Eligibility Criteria

Inclusion Criteria:

Diagnosis of Epithelial ovarian cancer confirmed
FIGO stage III-IV or carcinomatosis recurrence
No comorbidities or controlled comorbidities
ECOG 0-2

Exclusion Criteria:

without carcinomatosis

Accepts Healthy Volunteers

Sex

Female

Sex/Gender Based

Not provided

Sex/Gender Description

Not provided

Minimum Age

18 Years

Maximum Age

72 Years

Standard Ages

AdultOlder Adult

Study Population

HIPEC population: 46 patients No HIPEC population : 92 patients

Sampling Method

Non-Probability Sample

Condition Browse Module

MeSH Terms

ID	Term
D010051	Ovarian Neoplasms

Ancestor Terms

ID	Term
D004701	Endocrine Gland Neoplasms
D009371	Neoplasms by Site
D009369	Neoplasms
D010049	Ovarian Diseases

Browse Leaves

Not provided

Browse Branches

Not provided

Intervention Browse Module

MeSH Terms

ID	Term
D065426	Cytoreduction Surgical Procedures
D000084262	Hyperthermic Intraperitoneal Chemotherapy

Ancestor Terms

ID	Term
D013514	Surgical Procedures, Operative
D017024	Chemotherapy, Adjuvant
D003131	Combined Modality Therapy
D013812	Therapeutics

Browse Leaves

Not provided

Browse Branches

Not provided