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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT04135521
Recruitment Status : Completed
First Posted : October 22, 2019
Last Update Posted : June 29, 2020
Sponsor:
Information provided by (Responsible Party):
Sheng-Mou Hsiao, Far Eastern Memorial Hospital

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

Condition or disease Intervention/treatment
Advanced Ovarian Cancer Drug: Intraperitoneal chemotherapy

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.

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Study Type : Observational
Actual Enrollment : 50 participants
Observational Model: Cohort
Time Perspective: Retrospective
Official Title: Far Eastern Memorial Hospital
Actual Study Start Date : October 28, 2019
Actual Primary Completion Date : March 31, 2020
Actual Study Completion Date : March 31, 2020

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Ovarian Cancer


Intervention Details:
  • Drug: Intraperitoneal chemotherapy
    Intraperitoneal or intravenous dose-dense platinum/taxane chemotherapy
    Other Name: Intravenous dose-dense chemotherapy


Primary Outcome Measures :
  1. Progression-free survivals between this intraveous and intraperitoneal chemotherapy groups [ Time Frame: 10 years ]
    months


Secondary Outcome Measures :
  1. Overall survivals between this two groups [ Time Frame: 10 years ]
    months



Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.


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Ages Eligible for Study:   20 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   Female
Gender Based Eligibility:   Yes
Gender Eligibility Description:   advanced ovarian cancer woman
Accepts Healthy Volunteers:   No
Sampling Method:   Non-Probability Sample
Study Population
All consecutive women, who underwent intravenous dose-dense or intraperitoneal chemotherapy as the front-line chemotherapy were reviewed.
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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT04135521


Locations
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Taiwan
Department of Obstetrics and Gynecology, Far-Eastern Memorial Hospital
Banqiao, New Taipei, Taiwan, 22050
Sponsors and Collaborators
Far Eastern Memorial Hospital
  Study Documents (Full-Text)

Documents provided by Sheng-Mou Hsiao, Far Eastern Memorial Hospital:
Study Protocol  [PDF] October 22, 2019

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Responsible Party: Sheng-Mou Hsiao, Chief of Department of Obstetrics & Gynecology, Associate Professor, Far Eastern Memorial Hospital
ClinicalTrials.gov Identifier: NCT04135521    
Other Study ID Numbers: 108137-E
First Posted: October 22, 2019    Key Record Dates
Last Update Posted: June 29, 2020
Last Verified: June 2020
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Additional relevant MeSH terms:
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Ovarian Neoplasms
Carcinoma, Ovarian Epithelial
Endocrine Gland Neoplasms
Neoplasms by Site
Neoplasms
Ovarian Diseases
Adnexal Diseases
Genital Diseases, Female
Genital Neoplasms, Female
Urogenital Neoplasms
Endocrine System Diseases
Gonadal Disorders
Carcinoma
Neoplasms, Glandular and Epithelial
Neoplasms by Histologic Type