Ovarian CancerPhase 3NCT05371301
Efficacy of Primary Debulking Surgery Versus Neoadjuvant Chemotherapy in Stage IV Ovarian Cancer
A Phase 3 study testing Paclitaxel, Carboplatin and debulking surgery in people with Ovarian Cancer, run by Fudan University at 1 site in China.
Trial summary
Epithelial ovarian cancer is mostly diagnosed at late stage (III/IV), and the standard treatment for ovarian cancer includes primary debulking surgery and platinum-based adjuvant chemotherapy. Read more about this study
- Who is it for?
- Ages 18 years and older, women only
- Conditions the study is for
- Ovarian Cancer
- What is being tested?
- Paclitaxel, Carboplatin and debulking surgery
- Type of treatment
- Injection or infusion, Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 200 participants
- Where
- 1 siteChina
- Study dates
- 16 Jul 2021to Dec 2023
- 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 years and older
- Women only
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Female patients over 18 years of age.
- ECOG 0-2
- Clinically confirmed epithelial ovarian or fallopian-tube cancer or primary peritoneal cancer
- FIGO2014 stage III/IV
- Sign the informed consent form
- Good compliance and agree to cooperate with survival follow-up
Who cannot join
- Patients with large abdominal masses or other reasons for not being able to tolerate surgical treatment
- Patients with severe medical comorbidities that cannot be corrected in the short term and are not suitable for tumor cytoreductive surgery
- Patients with contraindications to chemotherapy
- Patients with a history of psychotropic substance abuse and unable to quit or patients with mental disorders
- Patients with serious safety hazards or concomitant diseases that, in the judgment of the institution, would affect the patient's ability to complete the study
Trial locations and contacts
1 site in 1 country.
China1 site, 1 recruiting
- Recruiting
Fudan university shanghai cancer center, Deparment of gynecologic oncology
Shanghai, Shanghai Municipality, 200000
Xiaohua Wu, PhD&MD, 86-21-64175590 ext. 88217, xh.wu@fudan.edu.cn
About this study
Official title: Efficacy of Primary Debulking Surgery Versus Neoadjuvant Chemotherapy in Stage IV Ovarian Cancer: a Phase III Randomized Controlled Study
Epithelial ovarian cancer is mostly diagnosed at late stage (III/IV), and the standard treatment for ovarian cancer includes primary debulking surgery and platinum-based adjuvant chemotherapy. However, scholars suggest that neoadjuvant chemotherapy can be used to reduce the tumor load and control the patient's condition. The aim of this study is to verify the efficacy of primary debulking surgery versus neoadjuvant chemotherapy.
Read the detailed description
Epithelial ovarian cancer (EOC) is one of the most common malignant tumors in women. Due to the insidious onset and the lack of effective early diagnosis measures, about 70% of patients with epithelial ovarian cancer are already in FIGO stage III-IV at the time of diagnosis. With extensive tumor dissemination and metastasis, the 5-year survival rate of EOC patients is only about 30-40%.
Currently, the standard treatment for ovarian cancer remains to include primary debulking surgery(PDS) and platinum-based adjuvant chemotherapy. Despite the lack of evidence from prospective randomized controlled studies, evidence invariably shows that satisfactory debulking surgery improves survival prognosis in advanced ovarian cancer and that this benefit is significantly associated with the amount of residual lesion.
How to increase the proportion of patients with satisfactory tumor reduction (residual lesions <1 cm) has long been a pressing issue for gynecologic oncologists. However, because ovarian cancer lesions are mainly disseminated in the pelvic cavity, the extent of surgery to achieve satisfactory reduction is often large and difficult to be tolerated for some patients. At the same time, due to the large initial tumor or the limited treatment level, some patients are unable to obtain satisfactory cytoreduction. Therefore, some scholars suggest that neoadjuvant chemotherapy (NACT) can be used to reduce the tumor load and control the patient's condition, followed by interval debulking surgery (IDS), called NACT-IDS treatment model.
Whether the NACT-IDS treatment model can be used as a conventional alternative to PDS has been controversial. The foundation for NACT-IDS was laid by two multicenter randomized controlled phase III clinical trials, EORTC 55971 and CHORUS. Both studies showed that the application of NACT in patients with advanced ovarian cancer resulted in a higher proportion of satisfactory cytoreduction and lower postoperative complications and mortality while ensuring a similar prognosis. However, the two studies mentioned above have been questioned by some scholars because of the lower median operative time, lower percentage of satisfactory cytoreduction, and lower patient prognosis than the international general level. Meanwhile, another phase III randomized controlled clinical trial, JCOG0602, was a non-inferiority trial, and the results did not confirm that NACT was not inferior to PDS. Therefore, at present, NCCN guidelines recommend that PDS remains the first choice for most patients.
At present, there are no relevant clinical trials comparing the impact of PDS with NACT on the prognosis of patients with ovarian cancer. In this study, investigators propose to assess the resectability of patients with abdominopelvic lesions using the Suidan standard resectability prediction model based on the evaluation of WB-DWI/MRI. In patients of stage IV ovarian cancer with resectable abdominopelvic lesions, the prognostic impact of PDS and NACT will be compared prospectively and randomly, with the aim of providing a new decision basis for the treatment of patients with stage IV ovarian cancer.
- Conditions
- Ovarian Cancer
- Being tested
- Paclitaxel, Carboplatin, debulking surgery
- Keywords
- Ovarian Cancer, Neoadjuvant Chemotherapy, Interval Debulking 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.
Paclitaxel, CarboplatinDrug
Paclitaxel 175mg/m2 iv d1 followed by Carboplatin(AUC=5) iv d1
debulking surgeryProcedure or surgery
Remove all visible tumors and any other tissues or organs where tumor may have spread, which may include:
Uterus Fallopian tubes Omentum (tissue that covers the stomach, large intestine and other abdominal organs) Lymph nodes Diaphragm Part of the large bowel Spleen Parts of the liver
| Study group | Role | What they receive |
|---|---|---|
| NACT-IDS | Experimental | For patients whoes WB-DWI/MRI Suidan Standard Evaluation≥4 Neoadjuvant chemotherapy: platinum-based combination regimen 3 courses Receives: Drug: Paclitaxel, Carboplatin; Procedure: debulking surgery |
| PDS | Active comparator | For patients whoes WB-DWI/MRI Suidan Standard Evaluation<4 Receives: Procedure: debulking surgery |
What is being measured
The primary outcome is the main question the study is designed to answer.
Progression-Free-Survival
Patients from surgery or neoadjuvant chemotherapy to disease progression or time to last follow-up
Measured: 5 year
overall survival
Patients from surgery or neoadjuvant chemotherapy to death or time to last follow-up
Measured: 5 year
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted12 May 2022
- Study start16 Jul 2021
- Primary completionDec 2022 (estimated)
- Study completionDec 2023 (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.
- More trials run by Fudan UniversityThe 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 3
- Primary purpose
- Treatment
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 200 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Fudan University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Xiaohua Wu MD, Fudan University
- Investigators
- Xiaohua Wu, PhD&MD, Principal investigator, Fudan university shanghai cancer center, Deparment of gynecologic oncology
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05371301
- Sponsor's protocol ID
- FUSCC-GYN-20200816
- Status last verified
- May 2022
- First submitted
- 28 Apr 2022
- Last updated
- 12 May 2022
- 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 12 May 2022. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Efficacy of Primary Debulking Surgery Versus Neoadjuvant Chemotherapy in Stage IV Ovarian Cancer: a Phase III Randomized Controlled Study
- ClinicalTrials.gov ID
- NCT05371301
- Acronym / sponsor ID
- FUSCC-GYN-20200816
- Conditions
- Ovarian Cancer
- Keywords
- Ovarian Cancer, Neoadjuvant Chemotherapy, Interval Debulking Surgery
- Phase
- Phase 3
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 200 participants (estimated)
- Lead sponsor
- Fudan UniversityUniversity, hospital or other
- Study start
- 16 Jul 2021 (actual)
- Primary completion
- Dec 2022 (estimated)
- Study completion
- Dec 2023 (estimated)
- First posted
- 12 May 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.
Epithelial ovarian cancer is mostly diagnosed at late stage (III/IV), and the standard treatment for ovarian cancer includes primary debulking surgery and platinum-based adjuvant chemotherapy. However, scholars suggest that neoadjuvant chemotherapy can be used to reduce the tumor load and control the patient's condition. The aim of this study is to verify the efficacy of primary debulking surgery versus neoadjuvant chemotherapy.
Detailed description
Epithelial ovarian cancer (EOC) is one of the most common malignant tumors in women. Due to the insidious onset and the lack of effective early diagnosis measures, about 70% of patients with epithelial ovarian cancer are already in FIGO stage III-IV at the time of diagnosis. With extensive tumor dissemination and metastasis, the 5-year survival rate of EOC patients is only about 30-40%.
Currently, the standard treatment for ovarian cancer remains to include primary debulking surgery(PDS) and platinum-based adjuvant chemotherapy. Despite the lack of evidence from prospective randomized controlled studies, evidence invariably shows that satisfactory debulking surgery improves survival prognosis in advanced ovarian cancer and that this benefit is significantly associated with the amount of residual lesion.
How to increase the proportion of patients with satisfactory tumor reduction (residual lesions <1 cm) has long been a pressing issue for gynecologic oncologists. However, because ovarian cancer lesions are mainly disseminated in the pelvic cavity, the extent of surgery to achieve satisfactory reduction is often large and difficult to be tolerated for some patients. At the same time, due to the large initial tumor or the limited treatment level, some patients are unable to obtain satisfactory cytoreduction. Therefore, some scholars suggest that neoadjuvant chemotherapy (NACT) can be used to reduce the tumor load and control the patient's condition, followed by interval debulking surgery (IDS), called NACT-IDS treatment model.
Whether the NACT-IDS treatment model can be used as a conventional alternative to PDS has been controversial. The foundation for NACT-IDS was laid by two multicenter randomized controlled phase III clinical trials, EORTC 55971 and CHORUS. Both studies showed that the application of NACT in patients with advanced ovarian cancer resulted in a higher proportion of satisfactory cytoreduction and lower postoperative complications and mortality while ensuring a similar prognosis. However, the two studies mentioned above have been questioned by some scholars because of the lower median operative time, lower percentage of satisfactory cytoreduction, and lower patient prognosis than the international general level. Meanwhile, another phase III randomized controlled clinical trial, JCOG0602, was a non-inferiority trial, and the results did not confirm that NACT was not inferior to PDS. Therefore, at present, NCCN guidelines recommend that PDS remains the first choice for most patients.
At present, there are no relevant clinical trials comparing the impact of PDS with NACT on the prognosis of patients with ovarian cancer. In this study, investigators propose to assess the resectability of patients with abdominopelvic lesions using the Suidan standard resectability prediction model based on the evaluation of WB-DWI/MRI. In patients of stage IV ovarian cancer with resectable abdominopelvic lesions, the prognostic impact of PDS and NACT will be compared prospectively and randomly, with the aim of providing a new decision basis for the treatment of patients with stage IV ovarian cancer.
Study design
- Primary purpose
- Treatment
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| NACT-IDS | Experimental | Drug: Paclitaxel, Carboplatin, Procedure: debulking surgeryFor patients whoes WB-DWI/MRI Suidan Standard Evaluation≥4 Neoadjuvant chemotherapy: platinum-based combination regimen 3 courses |
| PDS | Active comparator | Procedure: debulking surgeryFor patients whoes WB-DWI/MRI Suidan Standard Evaluation<4 |
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)
- Female patients over 18 years of age.
- ECOG 0-2
- Clinically confirmed epithelial ovarian or fallopian-tube cancer or primary peritoneal cancer
- FIGO2014 stage III/IV
- Sign the informed consent form
Key exclusion criteria (5 listed)
- Patients with large abdominal masses or other reasons for not being able to tolerate surgical treatment
- Patients with severe medical comorbidities that cannot be corrected in the short term and are not suitable for tumor cytoreductive surgery
- Patients with contraindications to chemotherapy
- Patients with a history of psychotropic substance abuse and unable to quit or patients with mental disorders
- Patients with serious safety hazards or concomitant diseases that, in the judgment of the institution, would affect the patient's ability to complete the study
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 |
|---|---|---|
| Paclitaxel, CarboplatinPaclitaxel 175mg/m2 iv d1 followed by Carboplatin(AUC=5) iv d1 | Drug | NACT-IDS |
| debulking surgeryRemove all visible tumors and any other tissues or organs where tumor may have spread, which may include: Uterus Fallopian tubes Omentum (tissue that covers the stomach, large intestine and other abdominal organs) Lymph nodes Diaphragm Part of the large bowel Spleen Parts of the liver | Procedure or surgery | NACT-IDS, PDS |
Primary outcome
Progression-Free-Survival
Time frame: 5 year
Patients from surgery or neoadjuvant chemotherapy to disease progression or time to last follow-up
overall survival
Time frame: 5 year
Patients from surgery or neoadjuvant chemotherapy to death or time to last follow-up
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 12 May 2022.
Related trials for Ovarian Cancer
Recruiting
Methylation Profiling in Self-Samples for Identification of (Epi)Genetic Biomarkers for Gynecological Cancers
Gynaecological Cancers, Ovarian Cancer
Recruiting
A Study to Compare Two Surgical Procedures in Individuals With BRCA1 Mutations to Assess Reduced Risk of Ovarian Cancer
Ovarian Carcinoma
RecruitingPhase 2
Investigation of Ubamatamab Combination Therapy in Adult Participants With Platinum-Resistant Ovarian Cancer
Ovarian Cancer, Fallopian Tube Cancer
Active, not recruitingPhase 1/2
Phase I/II Study of the Anti-Programmed Death Ligand-1 Durvalumab Antibody (MEDI4736) in Combination With Olaparib and/or Cediranib for Advanced Solid Tumors and Advanced or Recurrent Ovarian, Triple Negative Breast, Lung, Prostate and Colorectal Can...
Colorectal Neoplasms, Breast Neoplasms
Recruiting
The Vanguard Study: Testing a New Way to Screen for Cancer
Bladder Carcinoma, Breast Carcinoma
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.
Xiaohua Wu, PhD&MD principal investigator
Fudan university shanghai cancer center, Deparment of gynecologic oncology
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 Paclitaxel, Carboplatin and debulking surgery in people with Ovarian Cancer, run by Fudan 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 6 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 12 May 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.
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 Xiaohua Wu, PhD&MD (86-21-64175590 ext. 88217, wu.xh@fudan.edu.cn), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Progression-Free-Survival (time frame: 5 year). The study lists 2 primary outcomes in all. 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 12 May 2022.