Dose-dense Chemotherapy Versus Intraperitoneal Chemothera... | NCT04135521

Studies
Dose-dense Chemotherapy Versus Intraperitoneal Chemotherapy as First-line Chemotherapy in Advanced Ovarian Cancer

NCT04135521

Sponsor

Far Eastern Memorial Hospital

Status

Completed

Last Update Posted

Jun 29, 2020Actual

Enrollment

50Actual

Phase

Not provided

Conditions

Advanced Ovarian Cancer

Interventions

Intraperitoneal chemotherapy

Countries

Taiwan

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

Large Document Module

Document Has No Statistical Analysis Plan (SAP)

Derived Section

Miscellaneous Info Module

Version Holder

Status Module

Record Verification Date

Jun 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

Oct 28, 2019Actual

Primary Completion Date

Mar 31, 2020Actual

Completion Date

Mar 31, 2020Actual

First Submitted Date

Oct 19, 2019

First Submission Date that Met QC Criteria

Oct 19, 2019

First Posted Date

Oct 22, 2019Actual

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

Jun 25, 2020

Last Update Posted Date

Jun 29, 2020Actual

Sponsor/Collaborators Module

Responsible Party, by Official Title

Sheng-Mou Hsiao, Chief of Department of Obstetrics & Gynecology, Associate Professor, Far Eastern Memorial HospitalPrincipal Investigator

Lead Sponsor

Far Eastern Memorial HospitalOTHER

Collaborators

Not provided

Oversight Module

Has Data Monitoring Committee (DMC)

Not provided

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

To compare dose-dense chemotherapy with intraperitoneal chemotherapy in patients with advanced stage ovarian cancer.

Detailed Description

Women aged 20 and above, diagnosed with advanced stage ovarian cancer (FIGO stage II~IV), who had received debulking surgery, followed by adjuvant chemotherapy (either dose-dense or intraperitoneal) at our institution between 01 January 2006 and 31 December 2018 were included in the study. Patient characteristics, any treatment related side-effects (peri-operative and post-operative complications, chemotherapy related adverse events), treatment response (complete or partial response, stable disease or progressive disease), post-treatment surveillance (disease status: disease-free, recurrence or cancer-related death) will be recorded. Univariate and multivariate logistic regression analysis will be employed to evaluate the survival benefit of the two different chemotherapy 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

50Actual

Arms/Interventions Module

Arm Groups

Not provided

Interventions

Name	Type	Description	Arm Group Labels	Other Names
Intraperitoneal chemotherapy	Drug	Intraperitoneal or intravenous dose-dense platinum/taxane chemotherapy		Intravenous dose-dense chemotherapy

Outcomes Module

Primary Outcomes

Measure	Description	Time Frame
Progression-free survivals between this intraveous and intraperitoneal chemotherapy groups	months	10 years

Secondary Outcomes

Measure	Description	Time Frame
Overall survivals between this two groups	months	10 years

Other Outcomes

Not provided

Eligibility Module

Eligibility Criteria

Inclusion Criteria:

Women with FIGO stage II~IV ovarian cancer
At least one cycle of intravenous dose-dense or intraperitoneal chemotherapy had been administered as the front-line chemotherapy.

Exclusion Criteria:

none

Accepts Healthy Volunteers

Sex

Female

Sex/Gender Based

Yes

Sex/Gender Description

advanced ovarian cancer woman

Minimum Age

20 Years

Maximum Age

Not provided

Standard Ages

AdultOlder Adult

Study Population

All consecutive women, who underwent intravenous dose-dense or intraperitoneal chemotherapy as the front-line chemotherapy were reviewed.

Sampling Method

Non-Probability Sample

Contacts/Locations Module

Central Contacts

Not provided

Overall Officials

Not provided

Locations

Facility	Status	City	State	ZIP	Country	Contacts
Department of Obstetrics and Gynecology, Far-Eastern Memorial Hospital		Banqiao District	New Taipei	22050	Taiwan

IPD Sharing Statement Module

Plan to Share IPD

Description

Not provided

Types

Not provided

Time Frame

Not provided

Access Criteria

Not provided

URL

Not provided

Type	Includes Protocol	Includes SAP	Includes ICF	Document Label	Document Date	Document Uploaded Date	Document File Name
Prot	Yes	No	No	Study Protocol	Oct 22, 2019	Jun 13, 2020	Prot_000.pdf

Intervention Browse Module

MeSH Terms

ID	Term
D000084262	Hyperthermic Intraperitoneal Chemotherapy

Ancestor Terms

ID	Term
D017024	Chemotherapy, Adjuvant
D003131	Combined Modality Therapy
D013812	Therapeutics
D004358	Drug Therapy

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Browse Branches

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