Ovarian CancerPhase 2NCT05200260
Surgery Combined With Maintenance Targeted Therapy in the Treatment of Advanced Ovarian Cancer
A Phase 2 study testing Primary debulking surgery, Neoadjuvant chemotherapy and PARP inhibitor in people with Ovarian Cancer and Fallopian Tube Cancer, run by Shanghai Gynecologic Oncology Group at 9 sites in China.
Trial summary
Optimal Timing of Surgery combined with Maintenance Therapy in the Front-line Treatment of Advanced Ovarian Cancer Read more about this study
- Who is it for?
- Ages 18 years and older, women only
- Conditions the study is for
- Ovarian Cancer, Fallopian Tube Cancer, Primary Peritoneal Carcinoma
- What is being tested?
- Primary debulking surgery, Neoadjuvant chemotherapy and PARP inhibitor
- Type of treatment
- Injection or infusion, Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 220 participants
- Where
- 9 sitesChina
- Study dates
- 13 Jul 2022to Jun 2027
- Phase
- Phase 2
- 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
- Females aged ≥ 18 years.
- Pathologic confirmed stage IIIC and IV epithelial ovarian cancer, fallopian tube cancer or primary peritoneal carcinoma
- Low, Middle tumor burden and high tumor burden with cPCI score ≤ 12 based on pre-operative CT or PET/CT examination
- Complete cytoreduction can be achieved based on CT or PET/CT examination
- Patients must agree to undergo BRCA (breast cancer gene) and HRD (homologous recombination deficiency) testing
- Performance status (ECOG 0-2)
Show all 12Show fewer
- Adequate bone marrow, renal and hepatic function to receive chemotherapy and subsequent surgery:
- white blood cells >3,000/µL, absolute neutrophil count ≥1,500/µL, platelets ≥100,000/µL, hemoglobin ≥9 g/dL,
- serum creatinine <1.25 x upper normal limit (UNL) or creatinine clearance ≥60 mL/min according to Cockroft-Gault formula or to local lab measurement,
- serum bilirubin <1.25 x UNL, AST(SGOT) and ALT(SGPT) <2.5 x UNL.
- Comply with the study protocol and follow-up.
- Patients who have given their written informed consent.
Who cannot join
- Non-epithelial ovarian malignancies and borderline tumors
- Low grade ovarian cancer
- Mucinous ovarian cancer
- Complete cytoreduction cannot be achieved according to preoperative evaluation, including pulmonary and hepatic parenchymal metastases, unresectable extensive pleural metastases, multiple thoracic lymph nodes metastases, brain or bone metastases
- Patient has a known hypersensitivity to the components of olaparib/bevacizumab or its excipients
- Synchronous or metachronous (within 5 years) malignancy other than carcinoma in situ, thyroid carcinoma, or breast carcinoma (without any signs of relapse or activity, early-stage).
- Any other concurrent medical conditions contraindicating surgery or chemotherapy that could compromise adherence to the protocol.
- Other conditions, such as religious, psychological, and other factors, that could interfere with the provision of informed consent, compliance to study procedures, or follow-up.
Trial locations and contacts
9 sites in 1 country. Contact the study team or a site near you to ask about taking part.
9 sites in 1 country
China9 sites, 9 recruiting
- Recruiting
The First People's Hospital of Foshan
Foshan
Songhua Yuan, yuan-sh09@163.com
- Recruiting
Sun Yet-Sen University Cancer Center
Guangzhou
Chuyao Zhang, zhangchy@sysucc.org.cn
- Recruiting
The First Affiliated Hospital, Zhejiang University School of Medicine
Hangzhou
Jianhua Qian, qianjianhua@zju.edu.cn
- Recruiting
Zhejiang Cancer Hospital
Hangzhou
Yingli Zhang, zhangyl@zjcc.org.cn
- Recruiting
The First Affiliated Hospital of University of Science and Technology of China
Hefei
Ying Zhou, caddiezy@ustc.edu.cn
- Recruiting
Fudan University Cancer Hospital
Shanghai
Huijuan Yang, huijuanyang@hotmail.com
- Recruiting
Obstetrics and Gynecology Hospital of Fundan University
Shanghai
Wei Jiang, jiangwei1436@fckyy.org.cn
- Recruiting
Xinhua Hospital, Shanghai Jiao Tong University School of Medicine
Shanghai
Xipeng Wang, xipengwang@hotmail.com
- Recruiting
Zhongshan Hospital, Fudan University
Shanghai
Libing Xiang, 862164041990 ext. 2801, xiang.libing@zs-hospital.sh.cn
Libing Xiang
About this study
Official title: A Prospective, Multicenter, Randomized Phase II Trial on Optimal Timing of Surgery Combined With Maintenance Targeted Therapy in the Treatment of Advanced Ovarian Cancer
Optimal Timing of Surgery combined with Maintenance Therapy in the Front-line Treatment of Advanced Ovarian Cancer
Read the detailed description
The purpose of this trial is to answer the fundamental question 'The Optimal Timing of Surgery' combined with Bevacizumab or Poly-adenosine Ribose Phosphate Inhbitors (PARPi), in the circumstance of primarily diagnosed advanced epithelial ovarian cancer, fallopian tube cancer and primary peritoneal carcinoma.
- Being tested
- Primary debulking surgery, Neoadjuvant chemotherapy, PARP inhibitor, Bevacizumab
- Keywords
- Ovarian Cancer, Primary Debulking Surgery, Neoadjuvant chemotherapy, Poly-adenosine Ribose Phosphate Inhbitors (PARPi), Bevacizumab
- Medical subject headings
- Ovarian Neoplasms, Fallopian Tube Neoplasms
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Primary debulking surgeryProcedure or surgery
Also called PDS
Primary debulking surgery with a maximum cytoreduction, then followed by 6 cycles of Paclitaxel 175mg/m2 or Docetaxel 60-75 mg/m2 plus Carboplatin AUC (area under the curve) 5.
Neoadjuvant chemotherapyProcedure or surgery
Also called Neoadjuvant chemotherapy followed by interval debulking surgery, NACT-IDS
3 cycles of Paclitaxel 175mg/m2 or Docetaxel 60-75 mg/m2 plus Carboplatin AUC (area under the curve) 5, Interval debulking surgery with a maximal cytoreduction of complete gross resection, then followed by another 3 cycles of chemotherapy.
PARP inhibitorDrug
Also called Olaparib
For patients with BRCA mutated, maintenance therapy of PARP inhibitors following CR/PR after first-line chemotherapy. In this trial, Olaparib 300mg p.o. twice daily is suggested after the front-line therapy.
BevacizumabDrug
For patients without BRCA mutated, maintenance therapy of Bevacizumab following CR/PR after first-line chemotherapy. In this trial, Bevacizumab 7.5mg per kilogram intravenous once every 3 weeks is suggested after the front-line therapy.
| Study group | Role | What they receive |
|---|---|---|
| Upfront cytoreductive surgery with maintenance therapy | Experimental | Primary debulking surgery with a maximal cytoreduction of complete gross resection within 3 weeks after biopsy, followed by at least 6 cycles of adjuvant chemotherapy and maintenance therapy for patients with CR/PR after platinum-based therapy (patients with or without BRCA mutation will be maintained by PARPi or Bevacizumab respectively ). Receives: Procedure: Primary debulking surgery; Drug: PARP inhibitor; Drug: Bevacizumab |
| Neoadjuvant chemotherapy with maintenance therapy | Active comparator | Neoadjuvant chemotherapy with 3 cycles of chemotherapy, then followed by interval debulking surgery. The maximal time interval between course 3 chemotherapy and IDS is 6 weeks. And then 3 cycles of adjuvant chemotherapy and maintenance therapy for patients with CR/PR after platinum-based therapy (patients with or without BRCA mutation will be maintained by PARPi or Bevacizumab respectively ). Receives: Procedure: Neoadjuvant chemotherapy; Drug: PARP inhibitor; Drug: Bevacizumab |
What is being measured
The primary outcome is the main question the study is designed to answer.
3-year overall survival
The proportion of patients alive at 3 years after entry into the study
Measured: Participants will be followed for at least 3 years after randomization
Secondary outcomes (8)
Overall survival
Time from entry into the study to any cause of death
Measured: Participants will be followed for at least 3 years after randomization
Progression-free survival
Time from entry into the study to the diagnosis of the first progression or recurrence or death, whichever occurs first
Measured: Participants will be followed for at least 3 years after randomization
Post-operative complications
The surgical complications will be evaluated at 30-day, 60-day, 90-day after upfront cytoreductive surgery or interval debulking surgery
Measured: Participants will be followed up to 3 months after randomization
Quality of life assessments
QLQ-C30, FACT-Q (baseline; 6 months, 12 months, 24 months and 36 months after randomization)
Measured: Participants will be followed for at least 3 years after randomization
Accumulated treatment-free survival
Time from the date of randomization to death from any reason, minus the total treatment time of surgery and chemotherapy after randomization (regardless of targeted therapy)
Measured: Participants will be followed for at least 3 years or death after randomization
TFST
Time from the date of randomization until the starting date of the first subsequent anticancer therapy or death, whichever occurred first, whichever occurred first
Measured: Participants will be followed for at least 3 years or death after randomization
TSST
Time from the date of randomization until the starting date of the second subsequent anticancer therapy or death, whichever occurred first
Measured: Participants will be followed for at least 3 years or death after randomization
The pattern of the first relapse
The number and sites of the first relapse, including pelvic, abdominal, retroperitoneal lymph nodes, distant metastases and ascites will be compared between the two groups.
Measured: Participants will be followed for at least 3 years or death after randomization
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted20 Jan 2022
- Study start13 Jul 2022
- Primary completionJun 2027 (estimated)
- Study completionJun 2027 (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 2
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 220 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Shanghai Gynecologic Oncology Group
- Sponsor type
- Other government
- Collaborators
- Fudan University
- Responsible party
- Sponsor
- Investigators
- Libing Xiang, Study chair, Fudan University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05200260
- Sponsor's protocol ID
- SAT-1
- Status last verified
- Nov 2024
- First submitted
- 17 Jan 2022
- Last updated
- 10 Feb 2025
- Results posted
- No
- Data monitoring committee
- Yes
- 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 10 Feb 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Prospective, Multicenter, Randomized Phase II Trial on Optimal Timing of Surgery Combined With Maintenance Targeted Therapy in the Treatment of Advanced Ovarian Cancer
- ClinicalTrials.gov ID
- NCT05200260
- Acronym / sponsor ID
- SAT-1
- Keywords
- Ovarian Cancer, Primary Debulking Surgery, Neoadjuvant chemotherapy, Poly-adenosine Ribose Phosphate Inhbitors (PARPi), Bevacizumab
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 220 participants (estimated)
- Lead sponsor
- Shanghai Gynecologic Oncology GroupOther government
- Collaborators
- Fudan University
- Study start
- 13 Jul 2022 (actual)
- Primary completion
- Jun 2027 (estimated)
- Study completion
- Jun 2027 (estimated)
- First posted
- 20 Jan 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.
Optimal Timing of Surgery combined with Maintenance Therapy in the Front-line Treatment of Advanced Ovarian Cancer
Detailed description
The purpose of this trial is to answer the fundamental question 'The Optimal Timing of Surgery' combined with Bevacizumab or Poly-adenosine Ribose Phosphate Inhbitors (PARPi), in the circumstance of primarily diagnosed advanced epithelial ovarian cancer, fallopian tube cancer and primary peritoneal carcinoma.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Upfront cytoreductive surgery with maintenance therapy | Experimental | Procedure: Primary debulking surgery, Drug: PARP inhibitor, Drug: BevacizumabPrimary debulking surgery with a maximal cytoreduction of complete gross resection within 3 weeks after biopsy, followed by at least 6 cycles of adjuvant chemotherapy and maintenance therapy for patients with CR/PR after platinum-based therapy (patients with or without BRCA mutation will be maintained by PARPi or Bevacizumab respectively ). |
| Neoadjuvant chemotherapy with maintenance therapy | Active comparator | Procedure: Neoadjuvant chemotherapy, Drug: PARP inhibitor, Drug: BevacizumabNeoadjuvant chemotherapy with 3 cycles of chemotherapy, then followed by interval debulking surgery. The maximal time interval between course 3 chemotherapy and IDS is 6 weeks. And then 3 cycles of adjuvant chemotherapy and maintenance therapy for patients with CR/PR after platinum-based therapy (patients with or without BRCA mutation will be maintained by PARPi or Bevacizumab respectively ). |
Who may qualify
- Ages
- 18 years and older
- Sex
- Female only
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (12 listed)
- Females aged ≥ 18 years.
- Pathologic confirmed stage IIIC and IV epithelial ovarian cancer, fallopian tube cancer or primary peritoneal carcinoma
- Low, Middle tumor burden and high tumor burden with cPCI score ≤ 12 based on pre-operative CT or PET/CT examination
- Complete cytoreduction can be achieved based on CT or PET/CT examination
- Patients must agree to undergo BRCA (breast cancer gene) and HRD (homologous recombination deficiency) testing
Key exclusion criteria (8 listed)
- Non-epithelial ovarian malignancies and borderline tumors
- Low grade ovarian cancer
- Mucinous ovarian cancer
- Complete cytoreduction cannot be achieved according to preoperative evaluation, including pulmonary and hepatic parenchymal metastases, unresectable extensive pleural metastases, multiple thoracic lymph nodes metastases, brain or bone metastases
- Patient has a known hypersensitivity to the components of olaparib/bevacizumab or its excipients
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 |
|---|---|---|
| Primary debulking surgeryAlso: PDSPrimary debulking surgery with a maximum cytoreduction, then followed by 6 cycles of Paclitaxel 175mg/m2 or Docetaxel 60-75 mg/m2 plus Carboplatin AUC (area under the curve) 5. | Procedure or surgery | Upfront cytoreductive surgery with maintenance therapy |
| Neoadjuvant chemotherapyAlso: Neoadjuvant chemotherapy followed by interval debulking surgery, NACT-IDS3 cycles of Paclitaxel 175mg/m2 or Docetaxel 60-75 mg/m2 plus Carboplatin AUC (area under the curve) 5, Interval debulking surgery with a maximal cytoreduction of complete gross resection, then followed by another 3 cycles of chemotherapy. | Procedure or surgery | Neoadjuvant chemotherapy with maintenance therapy |
| PARP inhibitorAlso: OlaparibFor patients with BRCA mutated, maintenance therapy of PARP inhibitors following CR/PR after first-line chemotherapy. In this trial, Olaparib 300mg p.o. twice daily is suggested after the front-line therapy. | Drug | Neoadjuvant chemotherapy with maintenance therapy, Upfront cytoreductive surgery with maintenance therapy |
| BevacizumabFor patients without BRCA mutated, maintenance therapy of Bevacizumab following CR/PR after first-line chemotherapy. In this trial, Bevacizumab 7.5mg per kilogram intravenous once every 3 weeks is suggested after the front-line therapy. | Drug | Neoadjuvant chemotherapy with maintenance therapy, Upfront cytoreductive surgery with maintenance therapy |
Primary outcome
3-year overall survival
Time frame: Participants will be followed for at least 3 years after randomization
The proportion of patients alive at 3 years after entry into the study
8 secondary outcomes
Overall survival
Time frame: Participants will be followed for at least 3 years after randomization
Progression-free survival
Time frame: Participants will be followed for at least 3 years after randomization
Post-operative complications
Time frame: Participants will be followed up to 3 months after randomization
Quality of life assessments
Time frame: Participants will be followed for at least 3 years after randomization
Accumulated treatment-free survival
Time frame: Participants will be followed for at least 3 years or death after randomization
TFST
Time frame: Participants will be followed for at least 3 years or death after randomization
TSST
Time frame: Participants will be followed for at least 3 years or death after randomization
The pattern of the first relapse
Time frame: Participants will be followed for at least 3 years or death after randomization
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 10 Feb 2025.
- Individual participant dataSharing planned: No
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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.
Libing Xiang study chair
Fudan University
9 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 2 study testing Primary debulking surgery, Neoadjuvant chemotherapy and PARP inhibitor in people with Ovarian Cancer and Fallopian Tube Cancer, run by Shanghai Gynecologic Oncology Group at 9 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 12 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: looking for participants now, as of the sponsor's last update on 10 Feb 2025. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 9 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.
What does this phase mean?
Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
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 Libing Xiang (86 21 64041990 ext. 2801, xiang.libing@zs-hospital.sh.cn), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
3-year overall survival (time frame: Participants will be followed for at least 3 years after randomization). 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 10 Feb 2025.