Ovarian CancerPhase 3NCT04337632
Evaluation of the Sensitivity to Different Chemotherapy Regimens in Platinum-Partial Sensitive Recurrent Ovarian Cancer
A Phase 3 study testing Doxorubicin Hydrochloride Liposome Injection+carboplatin and paclitaxel +carboplatin in people with Ovarian Cancer, run by Hunan Cancer Hospital at 1 site in China.
Trial summary
Multicenter, prospective, randomized studies.Evaluation of the sensitivity to different chemotherapy regimens in platinum-partial sensitive recurrent ovarian cancer based on 11 gene tests of homologous recombination pathway. Read more about this study
- Who is it for?
- Ages 18 to 75 years
- Conditions the study is for
- Ovarian Cancer
- What is being tested?
- Doxorubicin Hydrochloride Liposome Injection+carboplatin and paclitaxel +carboplatin
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 338 participants
- Where
- 1 siteChina
- Study dates
- 1 Aug 2017to Jun 2021
- Phase
- Phase 3
- 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 18 to 75 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- age: 18-75 years old
- PS score: ECOG 0 ~ 2
- histopathologically confirmed primary high-grade serous adenocarcinoma or high-grade endometrioid adenocarcinoma of the ovary, fallopian tube or peritoneum;
- the time interval between this recurrence and the last chemotherapy was 6-12 months;
- evaluate the ability of bone marrow, liver, kidney, heart and other important organ functions to withstand chemotherapy;
- expected survival over 3 months;
- sign the informed consent.
Who cannot join
- brain metastasis or the presence of symptoms caused by brain metastasis;
- serious complications;
- acute inflammatory reaction;
- other tumors;
- a history of allergy to paclitaxel or polyropyridone liposomes;
Trial locations and contacts
1 site in 1 country.
China1 site, 1 recruiting
- Recruiting
Hunan Cancer Hospital
Changsha, Hunan, 410013
Jing Wang, MD., (86-0731)88651849, wangjing@hnca.org.cn
Jing Su, MD., (86-0731)89762815, sujing@hnca.org.cn
About this study
Official title: Evaluation of the Sensitivity to Different Chemotherapy Regimens in Platinum-Partial Sensitive Recurrent Ovarian Cancer Based on 11 Gene Tests of Homologous Recombination Pathway
Multicenter, prospective, randomized studies.Evaluation of the sensitivity to different chemotherapy regimens in platinum-partial sensitive recurrent ovarian cancer based on 11 gene tests of homologous recombination pathway.
Read the detailed description
Patients meeting the following inclusion criteria were randomly divided into two groups in a 1:1 ratio: paclitaxel/platinum chemotherapy group (TP) and Doxorubicin Hydrochloride Liposome Injection/platinum chemotherapy group (PP) (the specific chemotherapy regimens are as follows.Chemotherapy to tumor progression or adverse reactions can not be tolerated, effective chemotherapy patients with a maximum of 6 cycles of chemotherapy.The primary endpoint was progression-free survival (PFS), and the secondary endpoints were safety and overall survival.Also USES the next-generation sequencing (NGS) method to detect patients with recurrence after tumor tissues (including chest, ascites, homologous recombination pathway in the tumor tissue and peripheral blood ctDNA 11 genetic mutations, rearrangement, and so on and so forth, whether patients with analysing the homologous recombination pathways for paclitaxel/platinum chemotherapy or Doxorubicin Hydrochloride Liposome Injection/platinum chemotherapy has different sensitivity.
- Conditions
- Ovarian Cancer
- Being tested
- Doxorubicin Hydrochloride Liposome Injection+carboplatin, paclitaxel +carboplatin
- Medical subject headings
- Ovarian Neoplasms
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Doxorubicin Hydrochloride Liposome Injection+carboplatinDrug
Also called PP
Doxorubicin Hydrochloride Liposome Injection 25mg/m2, carboplatin AUC 5, first day, intravenous drip, repeated every three weeks.
paclitaxel +carboplatinDrug
Also called TP
paclitaxel 175mg/m2, carboplatin AUC 5, day 1, intravenous infusion, repeated every three weeks.
| Study group | Role | What they receive |
|---|---|---|
| PP | Experimental | Doxorubicin Hydrochloride Liposome Injection 25mg/m2, carboplatin AUC 5, day 1, intravenous drip, repeated every three weeks. Receives: Drug: Doxorubicin Hydrochloride Liposome Injection+carboplatin |
| TP | Active comparator | paclitaxel 175mg/m2, carboplatin AUC 5, day 1, intravenous infusion, repeated every three weeks. Receives: Drug: paclitaxel +carboplatin |
What is being measured
The primary outcome is the main question the study is designed to answer.
PFS（Progression-Free-Survival)
From the date of randomization to the time of tumor progression
Measured: up to 24months
Secondary outcomes (2)
OS(Overall survival)
Time from random day to death (month)
Measured: up to 36months
ORR( Objective response rate)
the percentage of patients whose tumors shrink a certain amount and stay that way for a certain amount of time
Measured: up to 12 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted8 Apr 2020
- Study start1 Aug 2017
- Primary completionJun 2021 (estimated)
- Study completionJun 2021 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for 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
- Interventional
- Phase
- Phase 3
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 338 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Hunan Cancer Hospital
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, JingWang, Hunan Cancer Hospital
- Investigators
- Jing Wang, MD., Study chair, Hunan Cancer Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04337632
- Sponsor's protocol ID
- 2016YFC1303703
- Status last verified
- Apr 2021
- First submitted
- 26 Mar 2020
- Last updated
- 8 Apr 2021
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 8 Apr 2021. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Evaluation of the Sensitivity to Different Chemotherapy Regimens in Platinum-Partial Sensitive Recurrent Ovarian Cancer Based on 11 Gene Tests of Homologous Recombination Pathway
- ClinicalTrials.gov ID
- NCT04337632
- Acronym / sponsor ID
- 2016YFC1303703
- Conditions
- Ovarian Cancer
- Phase
- Phase 3
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 338 participants (estimated)
- Lead sponsor
- Hunan Cancer HospitalUniversity, hospital or other
- Study start
- 1 Aug 2017 (actual)
- Primary completion
- Jun 2021 (estimated)
- Study completion
- Jun 2021 (estimated)
- First posted
- 8 Apr 2020 (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.
Multicenter, prospective, randomized studies.Evaluation of the sensitivity to different chemotherapy regimens in platinum-partial sensitive recurrent ovarian cancer based on 11 gene tests of homologous recombination pathway.
Detailed description
Patients meeting the following inclusion criteria were randomly divided into two groups in a 1:1 ratio: paclitaxel/platinum chemotherapy group (TP) and Doxorubicin Hydrochloride Liposome Injection/platinum chemotherapy group (PP) (the specific chemotherapy regimens are as follows.Chemotherapy to tumor progression or adverse reactions can not be tolerated, effective chemotherapy patients with a maximum of 6 cycles of chemotherapy.The primary endpoint was progression-free survival (PFS), and the secondary endpoints were safety and overall survival.Also USES the next-generation sequencing (NGS) method to detect patients with recurrence after tumor tissues (including chest, ascites, homologous recombination pathway in the tumor tissue and peripheral blood ctDNA 11 genetic mutations, rearrangement, and so on and so forth, whether patients with analysing the homologous recombination pathways for paclitaxel/platinum chemotherapy or Doxorubicin Hydrochloride Liposome Injection/platinum chemotherapy has different sensitivity.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| PP | Experimental | Drug: Doxorubicin Hydrochloride Liposome Injection+carboplatinDoxorubicin Hydrochloride Liposome Injection 25mg/m2, carboplatin AUC 5, day 1, intravenous drip, repeated every three weeks. |
| TP | Active comparator | Drug: paclitaxel +carboplatinpaclitaxel 175mg/m2, carboplatin AUC 5, day 1, intravenous infusion, repeated every three weeks. |
Who may qualify
- Ages
- 18 to 75 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (7 listed)
- age: 18-75 years old
- PS score: ECOG 0 ~ 2
- histopathologically confirmed primary high-grade serous adenocarcinoma or high-grade endometrioid adenocarcinoma of the ovary, fallopian tube or peritoneum;
- the time interval between this recurrence and the last chemotherapy was 6-12 months;
- evaluate the ability of bone marrow, liver, kidney, heart and other important organ functions to withstand chemotherapy;
Key exclusion criteria (5 listed)
- brain metastasis or the presence of symptoms caused by brain metastasis;
- serious complications;
- acute inflammatory reaction;
- other tumors;
- a history of allergy to paclitaxel or polyropyridone liposomes;
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 |
|---|---|---|
| Doxorubicin Hydrochloride Liposome Injection+carboplatinAlso: PPDoxorubicin Hydrochloride Liposome Injection 25mg/m2, carboplatin AUC 5, first day, intravenous drip, repeated every three weeks. | Drug | PP |
| paclitaxel +carboplatinAlso: TPpaclitaxel 175mg/m2, carboplatin AUC 5, day 1, intravenous infusion, repeated every three weeks. | Drug | TP |
Primary outcome
PFS（Progression-Free-Survival)
Time frame: up to 24months
From the date of randomization to the time of tumor progression
2 secondary outcomes
OS(Overall survival)
Time frame: up to 36months
ORR( Objective response rate)
Time frame: up to 12 months
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 8 Apr 2021.
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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.
Jing Wang, MD. study chair
Hunan Cancer Hospital
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 3 study testing Doxorubicin Hydrochloride Liposome Injection+carboplatin and paclitaxel +carboplatin in people with Ovarian Cancer, run by Hunan Cancer Hospital at 1 site in China.
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 7 inclusion and 5 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 8 Apr 2021. 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 China. 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.
What does this phase mean?
Phase 3 studies compare the treatment with the current standard treatment or a placebo in a large group, to confirm how well it works and watch for side effects.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
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?
Contact Jing Wang, MD. (（86-0731）88651849, wangjing@hnca.org.cn), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
PFS（Progression-Free-Survival) (time frame: up to 24months). 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 8 Apr 2021.