Relapsed Ovarian CancerNCT05607329
Secondary Cytoreduction Followed by Chemotherapy Versus Chemotherapy Alone in Relapsed Ovarian Cancer After PARPi Maintenance Treatment: a Multicentre, Open-label, Randomised, Phase 3 Trial
A study testing Secondary cytoreduction and Chemotherapy in people with Relapsed Ovarian Cancer, run by Women's Hospital School Of Medicine Zhejiang University at 1 site in China.
Trial summary
This study aims to carry out a multi-center, randomized controlled study on patients with recurrent ovarian cancer after PARPi maintenance, to explore the clinicopathological and molecular characteristics of patients with recurrent ovarian cancer after PARPi maintenance, and to clarify whether patients with recurrent… Read more about this study
- Who is it for?
- Ages 18 to 70 years, women only
- Conditions the study is for
- Relapsed Ovarian Cancer
- What is being tested?
- Secondary cytoreduction and Chemotherapy
- Type of treatment
- Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 400 participants
- Where
- 1 siteChina
- Study dates
- 1 May 2021to 1 May 2028
- Phase
- Interventional
- Are there results?
- Not yet: the study is under way
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 70 years
- Women only
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Patients with diagnosis of first-line or second-line recurrent epithelial ovarian carcinoma, peritoneal carcinoma, or fallopian tube carcinoma, who has previously received at least 4 cycles of platinum-based chemotherapy in initial treatment;
- Relapse occurred after 6 month since platinum-based chemotherapy;
- PARPi maintenance therapy for more than 6 months before relapse;
- R0 ideal debulking in initial surgery;
- PET-CT indicate the recurrence lesion is isolated and not exceed 5 sites, and the ascites is less than 500ml;
- ECOG/WHO Performance score of 0 to 1;
Show all 11Show fewer
- No hepatic failure, bilirubin ≤ 1,5 time the Normal limit, ASAT and ALAT ≤ 3 time the Upper Normal Limit
- No Renal insufficiency (serum creatinine < 1,5 time the normal limit, creatinine clearance > 80 mL/min). calculated with MDRD method
- Hematology function: PNN ≥ 1,5x10⁹/L, platelets ≥ 100x10⁹/L
- No contraindication to general anaesthesia for heavy surgery
- Patients having read, signed and dated Informed consent before any study procedure
Who cannot join
- Platinum-refractory/uncontrolled epithelial ovarian cancer;
- Non-epithelial ovarian tumor, mucinous, serous-mucinous (mainly mucinous), malignant Brenner tumor, low-grade serous carcinoma, borderline tumor;
- Suffering from other malignant tumors that have not achieved complete remission in the past 2 years;
- Received radiotherapy within 2 weeks before the start of the study intervention;
- General conditions cannot tolerate secondary cytoreduction;
- Severe hypersensitivity reactions (≥ grade 3) to paclitaxel or platinum and/or any of its excipients.
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
China1 site, 1 recruiting
- Recruiting
Women's Hospital, Zhejiang University School of Medicine
Hangzhou, Zhejiang, 310000
Yuanming Shen, Dr, 0086-13588193832, 11318160@zju.edu.cn
About this study
Official title: Secondary Cytoreduction Followed by Chemotherapy Versus Chemotherapy Alone in Relapsed Ovarian Cancer After PARPi Maintenance Treatment: a Multicenter, Open-label, Randomized, Phase 3 Trial
This study aims to carry out a multi-center, randomized controlled study on patients with recurrent ovarian cancer after PARPi maintenance, to explore the clinicopathological and molecular characteristics of patients with recurrent ovarian cancer after PARPi maintenance, and to clarify whether patients with recurrent ovarian cancer after PARPi maintenance for more than 6 months are sensitive to platinum drugs, and the value of secondary tumor cell reduction in such treatment, In order to provide evidence-based medicine basis for the standardized treatment mode of recurrent ovarian cancer after PARPi maintenance treatment.
- Conditions
- Relapsed Ovarian Cancer
- Being tested
- Secondary cytoreduction, Chemotherapy
- Medical subject headings
- Ovarian Neoplasms
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Secondary cytoreductionProcedure or surgery
Open surgery is conducted by senior clinicians in gynecological oncology. Operation time，location and number of relapsed lesions, location and number of excised lesions, Whether achieved R0 or not, and other information are recorded.
ChemotherapyDrug
chemotherapy
| Study group | Role | What they receive |
|---|---|---|
| Secondary cytoreduction followed by chemotherapy | Experimental | Not described Receives: Procedure: Secondary cytoreduction; Drug: Chemotherapy |
| chemotherapy alone | Active comparator | Not described Receives: Drug: Chemotherapy |
What is being measured
The primary outcome is the main question the study is designed to answer.
progression free survival (PFS)
progression free survival
Measured: 18-24 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted7 Nov 2022
- Study start1 May 2021
- Primary completion1 May 2026 (estimated)
- Study completion1 May 2028 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Relapsed 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 N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 400 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Women's Hospital School Of Medicine Zhejiang University
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05607329
- Sponsor's protocol ID
- SCAP-3
- Status last verified
- Jan 2022
- First submitted
- 2 Nov 2022
- Last updated
- 7 Nov 2022
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Publications
Chen T, Xu J, Xia B, Wang H, Shen Y. Secondary cytoreduction surgery for recurrent epithelial ovarian cancer patients after PARPi maintenance: A multicenter, randomized, controlled clinical trial. Int J Gynecol Cancer. 2024 Feb 5;34(2):328-331. doi: 10.1136/ijgc-2023-004978.
PubMed 38159938
Study at a glance
From the registry record, last updated by the sponsor on 7 Nov 2022. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Secondary Cytoreduction Followed by Chemotherapy Versus Chemotherapy Alone in Relapsed Ovarian Cancer After PARPi Maintenance Treatment: a Multicenter, Open-label, Randomized, Phase 3 Trial
- ClinicalTrials.gov ID
- NCT05607329
- Acronym / sponsor ID
- SCAP-3
- Conditions
- Relapsed Ovarian Cancer
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 400 participants (estimated)
- Lead sponsor
- Women's Hospital School Of Medicine Zhejiang UniversityUniversity, hospital or other
- Study start
- 1 May 2021 (actual)
- Primary completion
- 1 May 2026 (estimated)
- Study completion
- 1 May 2028 (estimated)
- First posted
- 7 Nov 2022 (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 carry out a multi-center, randomized controlled study on patients with recurrent ovarian cancer after PARPi maintenance, to explore the clinicopathological and molecular characteristics of patients with recurrent ovarian cancer after PARPi maintenance, and to clarify whether patients with recurrent ovarian cancer after PARPi maintenance for more than 6 months are sensitive to platinum drugs, and the value of secondary tumor cell reduction in such treatment, In order to provide evidence-based medicine basis for the standardized treatment mode of recurrent ovarian cancer after PARPi maintenance treatment.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Secondary cytoreduction followed by chemotherapy | Experimental | Procedure: Secondary cytoreduction, Drug: Chemotherapy |
| chemotherapy alone | Active comparator | Drug: Chemotherapy |
Who may qualify
- Ages
- 18 to 70 years
- Sex
- Female only
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (11 listed)
- Patients with diagnosis of first-line or second-line recurrent epithelial ovarian carcinoma, peritoneal carcinoma, or fallopian tube carcinoma, who has previously received at least 4 cycles of platinum-based chemotherapy in initial treatment;
- Relapse occurred after 6 month since platinum-based chemotherapy;
- PARPi maintenance therapy for more than 6 months before relapse;
- R0 ideal debulking in initial surgery;
- PET-CT indicate the recurrence lesion is isolated and not exceed 5 sites, and the ascites is less than 500ml;
Key exclusion criteria (6 listed)
- Platinum-refractory/uncontrolled epithelial ovarian cancer;
- Non-epithelial ovarian tumor, mucinous, serous-mucinous (mainly mucinous), malignant Brenner tumor, low-grade serous carcinoma, borderline tumor;
- Suffering from other malignant tumors that have not achieved complete remission in the past 2 years;
- Received radiotherapy within 2 weeks before the start of the study intervention;
- General conditions cannot tolerate secondary cytoreduction;
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 |
|---|---|---|
| Secondary cytoreductionOpen surgery is conducted by senior clinicians in gynecological oncology. Operation time，location and number of relapsed lesions, location and number of excised lesions, Whether achieved R0 or not, and other information are recorded. | Procedure or surgery | Secondary cytoreduction followed by chemotherapy |
| Chemotherapychemotherapy | Drug | Secondary cytoreduction followed by chemotherapy, chemotherapy alone |
Primary outcome
progression free survival (PFS)
Time frame: 18-24 months
progression free survival
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 7 Nov 2022.
- Derived from this study: PubMed 38159938Chen T, Xu J, Xia B, Wang H, Shen Y. Secondary cytoreduction surgery for recurrent epithelial ovarian cancer patients after PARPi maintenance: A multicenter, randomized, controlled clinical trial. Int J Gynecol Cancer. 2024 Feb 5;34(2):328-331. doi: 10.1136/ijgc-2023-004978.
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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.
Women's Hospital, Zhejiang University School of Medicine
Hangzhou, China
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Secondary cytoreduction and Chemotherapy in people with Relapsed Ovarian Cancer, run by Women's Hospital School Of Medicine Zhejiang University 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 11 inclusion and 6 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: looking for participants now, as of the sponsor's last update on 7 Nov 2022. 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.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Each site lists its own contact: choose the nearest one under Trial locations. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
progression free survival (PFS) (time frame: 18-24 months). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT05607329, which also lists 1 linked publication.
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 7 Nov 2022.