Advanced Ovarian CancerNCT04135521
Dose-dense Chemotherapy Versus Intraperitoneal Chemotherapy as First-line Chemotherapy in Advanced Ovarian Cancer
An observational study of Advanced Ovarian Cancer, run by Far Eastern Memorial Hospital at 1 site in Taiwan.
Trial summary
To compare dose-dense chemotherapy with intraperitoneal chemotherapy in patients with advanced stage ovarian cancer. Read more about this study
- Who is it for?
- Ages 20 years and older, women only
- Conditions the study is for
- Advanced Ovarian Cancer
- What is being tested?
- Intraperitoneal chemotherapy
- Type of treatment
- Injection or infusion
- How many people
- 50 participants
- Where
- 1 siteTaiwan
- Study dates
- 28 Oct 2019to 31 Mar 2020
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 20 years and older
- Women only
- No healthy volunteers
- Adult, Older adult
Study population: All consecutive women, who underwent intravenous dose-dense or intraperitoneal chemotherapy as the front-line chemotherapy were reviewed.
Who may be able to join
- 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.
Who cannot join
- none
Trial locations and contacts
1 site in 1 country.
Taiwan1 site
Department of Obstetrics and Gynecology, Far-Eastern Memorial Hospital
Banqiao District, New Taipei, 22050
About this study
Official title: Far Eastern Memorial Hospital
To compare dose-dense chemotherapy with intraperitoneal chemotherapy in patients with advanced stage ovarian cancer.
Read the 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.
- Conditions
- Advanced Ovarian Cancer
- Being tested
- Intraperitoneal chemotherapy
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Intraperitoneal chemotherapyDrug
Also called Intravenous dose-dense chemotherapy
Intraperitoneal or intravenous dose-dense platinum/taxane chemotherapy
What is being measured
The primary outcome is the main question the study is designed to answer.
Progression-free survivals between this intraveous and intraperitoneal chemotherapy groups
months
Measured: 10 years
Secondary outcomes (1)
Overall survivals between this two groups
months
Measured: 10 years
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted22 Oct 2019
- Study start28 Oct 2019
- Primary completion31 Mar 2020
- Study completion31 Mar 2020
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Advanced Ovarian CancerStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Cohort
- Time perspective
- Retrospective
- Enrolment
- 50 participants (actual)
Sponsor and investigators
- Lead sponsor
- Far Eastern Memorial Hospital
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Sheng-Mou Hsiao, Far Eastern Memorial Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04135521
- Sponsor's protocol ID
- 108137-E
- Status last verified
- Jun 2020
- First submitted
- 19 Oct 2019
- Last updated
- 29 Jun 2020
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 29 Jun 2020. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Far Eastern Memorial Hospital
- ClinicalTrials.gov ID
- NCT04135521
- Acronym / sponsor ID
- 108137-E
- Conditions
- Advanced Ovarian Cancer
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 50 participants (actual)
- Lead sponsor
- Far Eastern Memorial HospitalUniversity, hospital or other
- Study start
- 28 Oct 2019 (actual)
- Primary completion
- 31 Mar 2020 (actual)
- Study completion
- 31 Mar 2020 (actual)
- First posted
- 22 Oct 2019 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Observational model
- Cohort
- Time perspective
- Retrospective
Who may qualify
- Ages
- 20 years and older
- Sex
- Female only
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- All consecutive women, who underwent intravenous dose-dense or intraperitoneal chemotherapy as the front-line chemotherapy were reviewed.
Key inclusion criteria (2 listed)
- 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.
Key exclusion criteria (1 listed)
- none
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Intraperitoneal chemotherapyAlso: Intravenous dose-dense chemotherapyIntraperitoneal or intravenous dose-dense platinum/taxane chemotherapy | Drug | – |
Primary outcome
Progression-free survivals between this intraveous and intraperitoneal chemotherapy groups
Time frame: 10 years
months
1 secondary outcome
Overall survivals between this two groups
Time frame: 10 years
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 29 Jun 2020.
- Individual participant dataSharing planned: No
Related trials for Advanced Ovarian Cancer
Active, not recruitingPhase 1/2
Phase I/II Study of the Anti-Programmed Death Ligand-1 Durvalumab Antibody (MEDI4736) in Combination With Olaparib and/or Cediranib for Advanced Solid Tumors and Advanced or Recurrent Ovarian, Triple Negative Breast, Lung, Prostate and Colorectal Can...
Colorectal Neoplasms, Breast Neoplasms
RecruitingPhase 3
Torvutatug Samrotecan Plus Bevacizumab as First-line Maintenance in Non-Homologous Recombination Deficiency (Non-HRD) Positive Advanced Epithelial Ovarian Cancer
Epithelial Ovarian Cancer
RecruitingPhase 2
At-Home Cancer Directed Therapy Versus in Clinic for the Treatment of Patients With Advanced Cancer
Advanced Anal Carcinoma, Advanced Biliary Tract Carcinoma
Active, not recruitingPhase 1
A Phase 1 Study of XL309 (ISM3091) Alone and in Combination in Participants With Advanced Solid Tumors
Advanced Solid Tumor
RecruitingPhase 1
A Phase I Study of CG-7321 Monotherapy or Combination Therapy in Advanced Solid Tumors
Advanced Solid Tumors, Breast Cancer
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Advanced Ovarian Cancer, run by Far Eastern Memorial Hospital at 1 site in Taiwan.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 2 inclusion and 1 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 29 Jun 2020. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Taiwan. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Progression-free survivals between this intraveous and intraperitoneal chemotherapy groups (time frame: 10 years). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 29 Jun 2020.