Recurrent Ovarian CarcinomaSCENICNCT06292286
Secondary Interval Cytoreductive Surgery in Platinum-sensitive Recurrent Epithelial Ovarian Cancer
A study testing Carboplatin or cisplatin, Paclitaxel, gemcitabine or liposomal doxorubicin with or without bevacizumab or biosimilar and Bevacizumab or biosimilar in people with Recurrent Ovarian Carcinoma, run by The University of Hong Kong at 1 site in Hong Kong.
Trial summary
About 80% of advanced ovarian cancer patients recurred in 2-3 years. Secondary cytoreduction benefits selected patients who have high chance of complete resection. Whether secondary interval surgery can be used at recurrence is not known. Read more about this study
- Who is it for?
- Ages 18 years and older, women only
- Conditions the study is for
- Recurrent Ovarian Carcinoma
- What is being tested?
- Carboplatin or cisplatin, Paclitaxel, gemcitabine or liposomal doxorubicin with or without bevacizumab or biosimilar and Bevacizumab or biosimilar
- Type of treatment
- Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 18 participants
- Where
- 1 siteHong Kong
- Study dates
- 1 Nov 2023to 31 Dec 2026
- 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 years and older
- Women only
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Histologically diagnosed EOC, fallopian tube or primary peritoneal carcinoma
- >= 3 cycles of platinum-based chemotherapy, with or without bevacizumab and / or PARPi, at primary setting
- Platinum-free interval should be >=6 months from the last dose of platinum-based chemotherapy
- Upfront SCR not feasible
- Patients should have Eastern Cooperative Oncology Group (ECOG) performance score 0 to 2 within 28 days prior to recruitment.
- Patients must have adequate bone marrow, renal, hepatic and neurological function within 28 days prior to the start of treatment.
Who cannot join
- Non-epithelial or borderline tumors are excluded
- Patients who have with concurrent malignancy within five years (except for basal or squamous cell skin cancer, in-situ breast cancer, stage 1a grade 1-2 endometrioid endometrial carcinoma without lymphovascular invasion) are excluded.
- Patients using more than one line of chemotherapy are excluded.
- Patients who have platinum-resistant or refractory recurrence are excluded.
- Patients having second relapse or beyond are excluded.
- Patients who have contraindications to operation, e.g., unresolved thrombocytopenia, bowel obstruction in the last 4 weeks prior to enrolment
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
Hong Kong1 site, 1 recruiting
- Recruiting
The University of Hong Kong
Hong Kong
Lesley Lau, 852-22554518
Ka Yu Tse, 852-22554265, tseky@hku.hk
About this study
Official title: Secondary Neoadjuvant Chemotherapy and Interval Cytoreductive Surgery in Platinum-sensitive Recurrent Epithelial Ovarian Cancer Patients - a Pilot Study
About 80% of advanced ovarian cancer patients recurred in 2-3 years. Secondary cytoreduction benefits selected patients who have high chance of complete resection. Whether secondary interval surgery can be used at recurrence is not known.
Read the detailed description
Our study aims to evaluate the complete resection rate at interval cytoreductive surgery for recurrent ovarian cancer patients, and to determine the safety and survival outcomes of this approach.
- Conditions
- Recurrent Ovarian Carcinoma
- Being tested
- Carboplatin or cisplatin, Paclitaxel, gemcitabine or liposomal doxorubicin with or without bevacizumab or biosimilar, Bevacizumab or biosimilar, Cytoreductive surgery
- Medical subject headings
- Ovarian Neoplasms
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Carboplatin or cisplatinProcedure or surgery
Also called Paraplatin or Platinol
Carboplatin of cisplatin for 3-6 cycles
Paclitaxel, gemcitabine or liposomal doxorubicin with or without bevacizumab or biosimilarDrug
Also called Taxol, Gemzar, Caelyx
Paclitaxel, gemcitabine or liposomal doxorubicin, for 3-6 cycles
Bevacizumab or biosimilarDrug
Also called Avastin or mvasi
Optional
Cytoreductive surgeryProcedure or surgery
Cytoreductive surgery after chemotherapy
| Study group | Role | What they receive |
|---|---|---|
| Chemotherapy and surgery arm | Experimental | Patients receive platinum-based chemotherapy with or without bevacizumab, and then undergo cytoreductive operation, for the first recurrence of EOC. Receives: Procedure: Carboplatin or cisplatin; Drug: Paclitaxel, gemcitabine or liposomal doxorubicin with or without bevacizumab or biosimilar; Drug: Bevacizumab or biosimilar; Procedure: Cytoreductive surgery |
What is being measured
The primary outcome is the main question the study is designed to answer.
Complete resection rate
Rate of complete resection at the time of operation
Measured: 12 months
Secondary outcomes (4)
12-month progression-free survival rate
The time from the first dose of chemotherapy to the first documentation of objective tumor progression (PD) or to death due to any cause, whichever occurs first.
Measured: 12 months
12-month overall survival rate
Overall survival is defined as the time from the first dose of chemotherapy to the date of death due to any cause.
Measured: 12 months
Surgical complication rate
Complications are graded by the Clavien-Dindo classification
Measured: 12 months
Quality of life scale
Different functional scales will be assessed by questionnaires like the EORTC questionnaires where all scales range from 0-100. The higher the score, the greater the intensity of that particular item is.
Measured: 12 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted5 Mar 2024
- Study start1 Nov 2023
- Primary completion31 Dec 2026 (estimated)
- Study completion31 Dec 2026 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Recurrent Ovarian CarcinomaStudies of the same condition, open and under way.
- More trials run by The University of Hong KongThe sponsor's other registered studies.
- 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
- Not applicable
- Intervention model
- Single group
- Model description
- Neoadjuvant carboplatin and paclitaxel followed by cytoreductive surgery
- Masking
- None (open label)
- Enrolment
- 18 participants (estimated)
Sponsor and investigators
- Lead sponsor
- The University of Hong Kong
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Dr. Ka-Yu Tse, The University of Hong Kong
- Investigators
- Ka Yu Tse, Principal investigator, The University of Hong Kong
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06292286
- Sponsor's protocol ID
- UW 22-704
- Acronym
- SCENIC
- Status last verified
- Jun 2025
- First submitted
- 15 Dec 2023
- Last updated
- 11 Jun 2025
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 11 Jun 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Secondary Neoadjuvant Chemotherapy and Interval Cytoreductive Surgery in Platinum-sensitive Recurrent Epithelial Ovarian Cancer Patients - a Pilot Study
- ClinicalTrials.gov ID
- NCT06292286
- Acronym / sponsor ID
- SCENIC / UW 22-704
- Conditions
- Recurrent Ovarian Carcinoma
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 18 participants (estimated)
- Lead sponsor
- The University of Hong KongUniversity, hospital or other
- Study start
- 1 Nov 2023 (actual)
- Primary completion
- 31 Dec 2026 (estimated)
- Study completion
- 31 Dec 2026 (estimated)
- First posted
- 5 Mar 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.
About 80% of advanced ovarian cancer patients recurred in 2-3 years. Secondary cytoreduction benefits selected patients who have high chance of complete resection. Whether secondary interval surgery can be used at recurrence is not known.
Detailed description
Our study aims to evaluate the complete resection rate at interval cytoreductive surgery for recurrent ovarian cancer patients, and to determine the safety and survival outcomes of this approach.
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
- Model description
- Neoadjuvant carboplatin and paclitaxel followed by cytoreductive surgery
| Arm | Type | Receives |
|---|---|---|
| Chemotherapy and surgery arm | Experimental | Procedure: Carboplatin or cisplatin, Drug: Paclitaxel, gemcitabine or liposomal doxorubicin with or without bevacizumab or biosimilar, Drug: Bevacizumab or biosimilar, Procedure: Cytoreductive surgeryPatients receive platinum-based chemotherapy with or without bevacizumab, and then undergo cytoreductive operation, for the first recurrence of EOC. |
Who may qualify
- Ages
- 18 years and older
- Sex
- Female only
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (6 listed)
- Histologically diagnosed EOC, fallopian tube or primary peritoneal carcinoma
- >= 3 cycles of platinum-based chemotherapy, with or without bevacizumab and / or PARPi, at primary setting
- Platinum-free interval should be >=6 months from the last dose of platinum-based chemotherapy
- Upfront SCR not feasible
- Patients should have Eastern Cooperative Oncology Group (ECOG) performance score 0 to 2 within 28 days prior to recruitment.
Key exclusion criteria (6 listed)
- Non-epithelial or borderline tumors are excluded
- Patients who have with concurrent malignancy within five years (except for basal or squamous cell skin cancer, in-situ breast cancer, stage 1a grade 1-2 endometrioid endometrial carcinoma without lymphovascular invasion) are excluded.
- Patients using more than one line of chemotherapy are excluded.
- Patients who have platinum-resistant or refractory recurrence are excluded.
- Patients having second relapse or beyond are excluded.
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 |
|---|---|---|
| Carboplatin or cisplatinAlso: Paraplatin or PlatinolCarboplatin of cisplatin for 3-6 cycles | Procedure or surgery | Chemotherapy and surgery arm |
| Paclitaxel, gemcitabine or liposomal doxorubicin with or without bevacizumab or biosimilarAlso: Taxol, Gemzar, CaelyxPaclitaxel, gemcitabine or liposomal doxorubicin, for 3-6 cycles | Drug | Chemotherapy and surgery arm |
| Bevacizumab or biosimilarAlso: Avastin or mvasiOptional | Drug | Chemotherapy and surgery arm |
| Cytoreductive surgeryCytoreductive surgery after chemotherapy | Procedure or surgery | Chemotherapy and surgery arm |
Primary outcome
Complete resection rate
Time frame: 12 months
Rate of complete resection at the time of operation
4 secondary outcomes
12-month progression-free survival rate
Time frame: 12 months
12-month overall survival rate
Time frame: 12 months
Surgical complication rate
Time frame: 12 months
Quality of life scale
Time frame: 12 months
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 11 Jun 2025.
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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.
Ka Yu Tse principal investigator
The University of Hong Kong
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Carboplatin or cisplatin, Paclitaxel, gemcitabine or liposomal doxorubicin with or without bevacizumab or biosimilar and Bevacizumab or biosimilar in people with Recurrent Ovarian Carcinoma, run by The University of Hong Kong at 1 site in Hong Kong.
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 6 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 11 Jun 2025. 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 Hong Kong. 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?
Contact Lesley Lau (852-22554265, lsk382@hku.hk), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Complete resection rate (time frame: 12 months). 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 11 Jun 2025.