Cytoreductive SurgeryNCT05633199
Cytoreductive Surgery in Platinum-resistant Recurrent Ovarian Cancer
A study testing cytoreductive surgery in people with Cytoreductive Surgery, run by Women's Hospital School Of Medicine Zhejiang University at 2 sites in China.
Trial summary
This novel study was specifically designed for platinum-resistant recurrent ovarian cancers with PFI<6 months and aimed to compare prognosis of patients who received cytoreductive surgery followed by chemotherapy versus chemotherapy alone. Read more about this study
- Who is it for?
- Ages 18 to 70 years, women only
- Conditions the study is for
- Cytoreductive Surgery
- What is being tested?
- cytoreductive surgery
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 140 participants
- Where
- 2 sitesChina
- Study dates
- 1 Dec 2022to 1 Jan 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 epithelial ovarian carcinoma, peritoneal carcinoma, or fallopian tube carcinoma within 3 lines recurrence;
- Recurrence occurred within 6 months since platinum-based chemotherapy;
- R0 ideal debulking in initial surgery; PET-CT indicate the recurrence lesion is almost in abdominal cavity, which is isolated and not exceed 5 sites, and the ascites is less than 500ml;
- ECOG/WHO Performance score of 0 to 1;
- Hematology function: Leukocyte≥ 3,5x10⁹/L, neutrophil≥ 1,5x10⁹/L, platelets ≥ 100x10⁹/L;
- No Renal insufficiency: serum creatinine < 1,5 time the normal limit, creatinine clearance > 60 mL/min;
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- No hepatic failure: bilirubin ≤ 1,5 time the Normal limit;
- Patients with good compliance;
- Patients having read, signed and dated Informed consent before any study procedure.
Who cannot join
- Platinum-refractory/uncontrolled epithelial ovarian cancer;
- Mucous carcinoma or low-grade serous carcinoma;
- Suffering from other malignant tumors that have not achieved complete remission in the past 2 years;
- Patients have received abdominal or pelvic radiotherapy;
- General conditions cannot tolerate cytoreduction;
- Severe hypersensitivity reactions (≥ grade 3) to paclitaxel or platinum and/or any of its excipients;
- Unable or unwilling to sign the informed consent form;
- Patients judged by the investigator to be unlikely to follow the research steps, restrictions and requirements.
Trial locations and contacts
2 sites in 1 country. Contact the study team or a site near you to ask about taking part.
China2 sites
Women's Hospital, Zhejiang University School of Medicine
Hangzhou
Junfen Xu, Dr, 0086-13567147767, xjfzu@zju.edu.cn
Women's Hospital, Zhejiang University School of Medicine
Hangzhou
Junfen Xu, 0086-13567147767, xjfzu@zju.edu.cn
About this study
Official title: Cytoreductive Surgery in Platinum-resistant Recurrent Ovarian Cancer：a Randomized Controlled Study
This novel study was specifically designed for platinum-resistant recurrent ovarian cancers with PFI<6 months and aimed to compare prognosis of patients who received cytoreductive surgery followed by chemotherapy versus chemotherapy alone.
- Conditions
- Cytoreductive Surgery
- Being tested
- cytoreductive surgery
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
cytoreductive surgeryOther
Open surgery is conducted by senior doctors in gynecological oncology. The following parameters should be recorded: period of operation, location and number of recurrent lesions, location and number of resected lesions, amount of intraoperative bleeding and blood transfusion, whether R0 is reached, size and distribution of residual lesions, surgical complications, hospital stay, and period to adjuvant chemotherapy. Patients are required to start intravenous chemotherapy within 4W after surgery, at least for 4 cycles.
| Study group | Role | What they receive |
|---|---|---|
| cytoreduction surgery followed by chemotherapy | Experimental | Not described Receives: Other: cytoreductive surgery |
| chemotherapy alone | No intervention | Not described |
What is being measured
The primary outcome is the main question the study is designed to answer.
PFS
period from the end of treatment to the recurrence of disease
Measured: month 6
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted1 Dec 2022
- Study start1 Dec 2022 (estimated)
- Primary completion1 Nov 2026 (estimated)
- Study completion1 Jan 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 Cytoreductive SurgeryStudies 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
- Single blind
- Who is masked
- Participant
- Enrolment
- 140 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
- NCT05633199
- Sponsor's protocol ID
- CSPROC
- Status last verified
- Nov 2022
- First submitted
- 20 Nov 2022
- Last updated
- 1 Dec 2022
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Publications
Chen T, Xu J, Xia B, Wang H, Shen Y. Evaluation of secondary cytoreduction surgery in platinum-resistant ovarian cancer patients within three-line recurrent: a multicenter, randomized controlled study. J Gynecol Oncol. 2024 Jan;35(1):e22. doi: 10.3802/jgo.2024.35.e22. Epub 2023 Oct 30.
PubMed 37945326
Study at a glance
From the registry record, last updated by the sponsor on 1 Dec 2022. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Cytoreductive Surgery in Platinum-resistant Recurrent Ovarian Cancer：a Randomized Controlled Study
- ClinicalTrials.gov ID
- NCT05633199
- Acronym / sponsor ID
- CSPROC
- Conditions
- Cytoreductive Surgery
- Study type
- Interventional
- Recruitment status
- Not yet recruiting
- Enrolment
- 140 participants (estimated)
- Lead sponsor
- Women's Hospital School Of Medicine Zhejiang UniversityUniversity, hospital or other
- Study start
- 1 Dec 2022 (estimated)
- Primary completion
- 1 Nov 2026 (estimated)
- Study completion
- 1 Jan 2028 (estimated)
- First posted
- 1 Dec 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 novel study was specifically designed for platinum-resistant recurrent ovarian cancers with PFI<6 months and aimed to compare prognosis of patients who received cytoreductive surgery followed by chemotherapy versus chemotherapy alone.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (participant)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| cytoreduction surgery followed by chemotherapy | Experimental | Other: cytoreductive surgery |
| chemotherapy alone | No intervention | – |
Who may qualify
- Ages
- 18 to 70 years
- Sex
- Female only
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (9 listed)
- Patients with diagnosis of epithelial ovarian carcinoma, peritoneal carcinoma, or fallopian tube carcinoma within 3 lines recurrence;
- Recurrence occurred within 6 months since platinum-based chemotherapy;
- R0 ideal debulking in initial surgery; PET-CT indicate the recurrence lesion is almost in abdominal cavity, which is isolated and not exceed 5 sites, and the ascites is less than 500ml;
- ECOG/WHO Performance score of 0 to 1;
- Hematology function: Leukocyte≥ 3,5x10⁹/L, neutrophil≥ 1,5x10⁹/L, platelets ≥ 100x10⁹/L;
Key exclusion criteria (8 listed)
- Platinum-refractory/uncontrolled epithelial ovarian cancer;
- Mucous carcinoma or low-grade serous carcinoma;
- Suffering from other malignant tumors that have not achieved complete remission in the past 2 years;
- Patients have received abdominal or pelvic radiotherapy;
- General conditions cannot tolerate 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 |
|---|---|---|
| cytoreductive surgeryOpen surgery is conducted by senior doctors in gynecological oncology. The following parameters should be recorded: period of operation, location and number of recurrent lesions, location and number of resected lesions, amount of intraoperative bleeding and blood transfusion, whether R0 is reached, size and distribution of residual lesions, surgical complications, hospital stay, and period to adjuvant chemotherapy. Patients are required to start intravenous chemotherapy within 4W after surgery, at least for 4 cycles. | Other | cytoreduction surgery followed by chemotherapy |
Primary outcome
PFS
Time frame: month 6
period from the end of treatment to the recurrence of disease
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 1 Dec 2022.
- Derived from this study: PubMed 37945326Chen T, Xu J, Xia B, Wang H, Shen Y. Evaluation of secondary cytoreduction surgery in platinum-resistant ovarian cancer patients within three-line recurrent: a multicenter, randomized controlled study. J Gynecol Oncol. 2024 Jan;35(1):e22. doi: 10.3802/jgo.2024.35.e22. Epub 2023 Oct 30.
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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
Women's Hospital, Zhejiang University School of Medicine
Hangzhou, China
2 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing cytoreductive surgery in people with Cytoreductive Surgery, run by Women's Hospital School Of Medicine Zhejiang University at 2 sites 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 9 inclusion and 8 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: opening soon, as of the sponsor's last update on 1 Dec 2022. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 2 sites 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?
PFS (time frame: month 6). 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 NCT05633199, 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 1 Dec 2022.