Intravenous Chemotherapy Versus Intraperitoneal Chemotherapy in Recurrent Ovarian CancerNCT06535334
Intraperitoneal Chemotherapy in Recurrent Ovarian Cancer
An observational study of Intravenous Chemotherapy Versus Intraperitoneal Chemotherapy in Recurrent Ovarian Cancer, run by Far Eastern Memorial Hospital at 1 site in Taiwan.
Trial summary
This study aims to compare intravenous chemotherapy versus intraperitoneal chemotherapy in patients with recurrent ovarian cancer. Read more about this study
- Who is it for?
- Ages 20 years and older, women only
- Conditions the study is for
- Intravenous Chemotherapy Versus Intraperitoneal Chemotherapy in Recurrent Ovarian Cancer
- What is being tested?
- Chemotherapy
- Type of treatment
- Injection or infusion
- How many people
- 80 participants
- Where
- 1 siteTaiwan
- Study dates
- 15 Aug 2024to May 2026
- 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: woman with recurrent ovarian cancer who was treated with chemotherapy (either intravenous or intraperitoneal)
Who may be able to join
- women who had recurrent ovarian cancer and was treated with either intravenous or intraperitoneal platinum based chemotherapy
Who cannot join
- women who did not complete the designated treatment course (exception to those who had to quit due to progressive disease or death of any cause)
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: Intravenous Chemotherapy Versus Intraperitoneal Chemotherapy in Recurrent Ovarian Cancer
This study aims to compare intravenous chemotherapy versus intraperitoneal chemotherapy in patients with recurrent ovarian cancer.
- Being tested
- Chemotherapy
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
ChemotherapyDrug
Intravenous chemotherapy versus intraperitoneal chemotherapy in recurrent ovarian cancer
| Study group | Role | What they receive |
|---|---|---|
| intravenous chemotherapy | triweekly chemotherapy with carboplatin AUC=5~6 + liposomal-doxorubicin 30~40mg/m2 or paclitaxel 175mg/m2 0r docetaxel 60~75mg/m2 Receives: Drug: Chemotherapy | |
| intraperitoneal chemotherapy | Day 1 IV Paclitaxel 135 mg/m2 + IP Cisplatin 75-100 mg/m2 or IP carboplatin (AUC = 6) Day 8 IP Paclitaxel 60 mg/m2 Every 21 days * 6 cycles
OR
Day 1 IP Carboplatin AUC=5 or IP Cisplatin 50-75mg/m2 Day 2 IV Liposomal doxorubicin 15 mg/m2 + IP Liposomal doxorubicin 15 mg/m2 Every 28 days * 6 cycles Receives: Drug: Chemotherapy |
What is being measured
The primary outcome is the main question the study is designed to answer.
RFS
Recurrence free survival
Measured: the time interval from the date of surgery or the start of chemotherapy to clinically defined recurrence, disease progression, death from any cause or last follow-up
OS
Overall Survival
Measured: the time interval from the date of surgery or the start of chemotherapy to the date of death from any cause or last follow-up
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted2 Aug 2024
- Study start15 Aug 2024 (estimated)
- Primary completionJun 2025 (estimated)
- Study completionMay 2026 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Intravenous Chemotherapy Versus Intraperitoneal Chemotherapy in Recurrent 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
- Case-control
- Time perspective
- Retrospective
- Enrolment
- 80 participants (estimated)
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
- NCT06535334
- Sponsor's protocol ID
- 113130-E
- Status last verified
- Jul 2024
- First submitted
- 6 Jun 2024
- Last updated
- 2 Aug 2024
- Results posted
- No
- Data monitoring committee
- 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 2 Aug 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Intravenous Chemotherapy Versus Intraperitoneal Chemotherapy in Recurrent Ovarian Cancer
- ClinicalTrials.gov ID
- NCT06535334
- Acronym / sponsor ID
- 113130-E
- Study type
- Observational
- Recruitment status
- Unknown status
- Enrolment
- 80 participants (estimated)
- Lead sponsor
- Far Eastern Memorial HospitalUniversity, hospital or other
- Study start
- 15 Aug 2024 (estimated)
- Primary completion
- Jun 2025 (estimated)
- Study completion
- May 2026 (estimated)
- First posted
- 2 Aug 2024 (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.
This study aims to compare intravenous chemotherapy versus intraperitoneal chemotherapy in patients with recurrent ovarian cancer.
Study design
- Observational model
- Case-control
- Time perspective
- Retrospective
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| intravenous chemotherapy | – | Drug: Chemotherapytriweekly chemotherapy with carboplatin AUC=5~6 + liposomal-doxorubicin 30~40mg/m2 or paclitaxel 175mg/m2 0r docetaxel 60~75mg/m2 |
| intraperitoneal chemotherapy | – | Drug: ChemotherapyDay 1 IV Paclitaxel 135 mg/m2 + IP Cisplatin 75-100 mg/m2 or IP carboplatin (AUC = 6) Day 8 IP Paclitaxel 60 mg/m2 Every 21 days * 6 cycles OR Day 1 IP Carboplatin AUC=5 or IP Cisplatin 50-75mg/m2 Day 2 IV Liposomal doxorubicin 15 mg/m2 + IP Liposomal doxorubicin 15 mg/m2 Every 28 days * 6 cycles |
Who may qualify
- Ages
- 20 years and older
- Sex
- Female only
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- woman with recurrent ovarian cancer who was treated with chemotherapy (either intravenous or intraperitoneal)
Key inclusion criteria (1 listed)
- women who had recurrent ovarian cancer and was treated with either intravenous or intraperitoneal platinum based chemotherapy
Key exclusion criteria (1 listed)
- women who did not complete the designated treatment course (exception to those who had to quit due to progressive disease or death of any cause)
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 |
|---|---|---|
| ChemotherapyIntravenous chemotherapy versus intraperitoneal chemotherapy in recurrent ovarian cancer | Drug | intraperitoneal chemotherapy, intravenous chemotherapy |
Primary outcome
RFS
Time frame: the time interval from the date of surgery or the start of chemotherapy to clinically defined recurrence, disease progression, death from any cause or last follow-up
Recurrence free survival
OS
Time frame: the time interval from the date of surgery or the start of chemotherapy to the date of death from any cause or last follow-up
Overall Survival
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 2 Aug 2024.
- Individual participant dataSharing planned: No
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 Intravenous Chemotherapy Versus Intraperitoneal Chemotherapy in Recurrent 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 1 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: status not confirmed, as of the sponsor's last update on 2 Aug 2024. 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?
Results are not available in the source record.
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?
RFS (time frame: the time interval from the date of surgery or the start of chemotherapy to clinically defined recurrence, disease progression, death from any cause or last follow-up). The study lists 2 primary outcomes in all. 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 2 Aug 2024.