Actively Recruiting

Phase 3
Age: 18Years - 75Years
FEMALE
ID05737303

Nab-paclitaxel Versus Solvent-based Taxanes As First-Line Treatment for Patients With Advanced Ovarian Cancer

Led by Women's Hospital School Of Medicine Zhejiang University · Updated on 2025-02-11

538

Participants Needed

11

Research Sites

104 weeks

Total Duration

On this page

Sponsors

W

Women's Hospital School Of Medicine Zhejiang University

Lead Sponsor

J

Jiaxing Maternity and Child Health Care Hospital

Collaborating Sponsor

AI-Summary

What this Trial Is About

Researchers are evaluating the safety and effectiveness of nab-paclitaxel compared to solvent-based taxanes as first-line treatments for patients with advanced primary epithelial ovarian cancer, primary peritoneal carcinoma, or fallopian tube carcinoma. This Phase 3 study aims to address challenges such as high rates of allergic reactions seen with solvent-based taxanes and explores whether nab-paclitaxel can be a feasible initial treatment option for these cancers. The study compares two main treatment groups: one receives nab-paclitaxel combined with carboplatin either every three weeks or weekly for six cycles, and the other receives paclitaxel combined with carboplatin in similar dosing schedules. Treatments are given intravenously with specific doses and timing, repeated every 21 days over 18 weeks in total. Both groups undergo systemic therapy after surgery if applicable. Participants will have regular clinical visits for treatment administration and monitoring. Researchers will assess outcomes such as progression-free survival over 20 months, remission rates at 12 months, overall survival at 3 and 5 years, and adverse events during these periods. The study includes various evaluations like physical condition, tumor response, and safety checks to track participant health and treatment effects throughout the trial duration.

CONDITIONS

Brief Title

Nab-paclitaxel Versus Sb-taxanes As First-Line Treatment in Advanced Ovarian Cancer

Who Can Participate

Age: 18Years - 75Years
FEMALE

Eligibility Criteria

Eligible

You may qualify if you...

  • Diagnosed with epithelial ovarian cancer, tubal cancer, or peritoneal cancer by histopathology or cytopathology
  • Cancer classified as stage III or IV according to FIGO staging
  • Physical condition with Eastern Cooperative Oncology Group (ECOG) PS score between 0 and 2
  • No participation in other drug clinical trials within 4 weeks prior to enrollment
  • Provided written informed consent
  • Expected survival of 6 months or more
  • Disease meets RECIST 1.1 criteria for tumor evaluation
  • Able to comply with outpatient treatment, laboratory monitoring, and clinical visits during study participation
Not Eligible

You will not qualify if you...

  • Presence of low malignant potential ovarian tumors
  • History of other malignant tumors within past 5 years except cured cervical carcinoma in situ or non-melanoma skin cancer
  • Prior chemotherapy or radiotherapy for pelvic cavity
  • Central nervous system metastasis or peripheral neuropathy greater than grade 1
  • Severe myelosuppression, liver dysfunction (Child's Class III), or renal dysfunction at screening
  • Severe cardiovascular diseases including grade I or higher myocardial ischemia or infarction, poorly controlled arrhythmias, NYHA grade II to III cardiac insufficiency, or left ventricular ejection fraction less than 55%
  • Uncontrolled systemic infection requiring treatment
  • Arteriovenous thrombosis events within 6 months before randomization
  • Allergy to albumin paclitaxel or carboplatin components
  • Pregnant or breastfeeding women
  • Considered unsuitable by researchers for inclusion

AI-Screening

AI-Powered Screening

Complete this quick 3-step screening to check your eligibility

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Your Study Journey

Screening

Duration - 2 to 4 weeks

Participants are screened for eligibility to participate in the trial.

1 visit (in-person)

Treatment

Duration - Approximately 18 weeks (6 cycles of 3 weeks each)

Participants receive one of the study drugs: nab-paclitaxel combined with carboplatin or paclitaxel combined with carboplatin, administered intravenously in cycles.

Weekly or every 3 weeks visits for drug administration depending on treatment arm

Follow-up

Duration - Up to 3 to 5 years

Participants are monitored for safety, survival, and disease progression after treatment ends.

Periodic visits depending on study schedule

Trial Site Locations

Total: 11 locations

1

Sun Yat-Sen University Cancer Hospital

Guangzhou, Guangdong, China

Not Yet Recruiting

2

Qilu Hospital of Shandong University

Ji'nan, Shandong, China, 250012

Not Yet Recruiting

3

Yaxia Chen

Hangzhou, Zhejiang, China, 310006

Actively Recruiting

4

Sir Run Run Hospital

Hangzhou, Zhejiang, China

Not Yet Recruiting

5

The First Affiliated Hospital of Medical College of Zhejiang University

Hangzhou, Zhejiang, China

Not Yet Recruiting

6

The Second Affiliated Hospital of Medical College of Zhejiang University

Hangzhou, Zhejiang, China

Not Yet Recruiting

7

Zhejiang Cancer Hospital

Hangzhou, Zhejiang, China

Not Yet Recruiting

8

Ningbo women's and children's Hospital

Ningbo, Zhejiang, China

Not Yet Recruiting

9

The No, 1 People's Hospital of Ningbo

Ningbo, Zhejiang, China

Not Yet Recruiting

10

The Second Affiliated Hospital of Wenzhou Medical University

Wenzhou, Zhejiang, China

Not Yet Recruiting

11

The First Affiliated Hospital of Wenzhou Medical University

Wenzhou, China

Not Yet Recruiting

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Research Team

Y

Yaxia Chen, MD

Y

Yang Li, MD

How is the study designed?

Study Type

INTERVENTIONAL

Masking

DOUBLE

Allocation

RANDOMIZED

Model

PARALLEL

Primary Purpose

OTHER

Number of Arms

2

Frequently Asked Questions

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Published Research Related To This Trial

Global Cancer Statistics 2020: GLOBOCAN Estimates of Incidence and Mortality Worldwide for 36 Cancers in 185 Countries.

Hyuna Sung, Jacques Ferlay, Rebecca L Siegel...

https://pubmed.ncbi.nlm.nih.gov/33538338

Testicular papillary serous carcinoma of ovarian type, a rare case report, however an important timely diagnostic issue.

Shahryar Zeighami, Mohammadreza Soltani, Fatemeh Khajeh...

https://pubmed.ncbi.nlm.nih.gov/33102004

The use of PIPAC (pressurized intraperitoneal aerosol chemotherapy) in gynecological oncology: a statement by the "Arbeitsgemeinschaft Gynaekologische Onkologie Studiengruppe Ovarialkarzinom (AGO-OVAR)", the Swiss and Austrian AGO, and the North-Eastern German Society of Gynaecologic Oncology.

A M Dueckelmann, D Fink, P Harter...

https://pubmed.ncbi.nlm.nih.gov/29356953

Systemic treatment of newly diagnosed advanced epithelial ovarian cancer: From chemotherapy to precision medicine.

J Alejandro Perez-Fidalgo, Francisco Grau, Lorena Fariñas...

https://pubmed.ncbi.nlm.nih.gov/33388455

Comparing Paclitaxel-Carboplatin with Paclitaxel-Cisplatin as the Front-Line Chemotherapy for Patients with FIGO IIIC Serous-Type Tubo-Ovarian Cancer.

Chen-Yu Huang, Min Cheng, Na-Rong Lee...

https://pubmed.ncbi.nlm.nih.gov/32224896

Phase III trial of carboplatin and paclitaxel compared with cisplatin and paclitaxel in patients with optimally resected stage III ovarian cancer: a Gynecologic Oncology Group study.

Robert F Ozols, Brian N Bundy, Benjamin E Greer...

https://pubmed.ncbi.nlm.nih.gov/12860964

A Difference in the Incidences of Hypersensitivity Reactions to Original and Generic Taxanes.

Tanchanok Ratanajarusiri, Virote Sriuranpong, Piyada Sitthideatphaiboon...

https://pubmed.ncbi.nlm.nih.gov/27997900

2004 consensus statements on the management of ovarian cancer: final document of the 3rd International Gynecologic Cancer Intergroup Ovarian Cancer Consensus Conference (GCIG OCCC 2004).

A du Bois, M Quinn, T Thigpen...

https://pubmed.ncbi.nlm.nih.gov/16239238