Trial Title:
Nab-paclitaxel Versus Sb-taxanes As First-Line Treatment in Advanced Ovarian Cancer
NCT ID:
NCT05737303
Condition:
Epithelial Ovarian Carcinoma Stage III
Epithelial Ovarian Carcinoma Stage IV
Fallopian Tube Carcinoma Stage III
Fallopian Tube Carcinoma Stage IV
Primary Peritoneal Carcinoma Stage III
Primary Peritoneal Carcinoma Stage IV
Conditions: Official terms:
Carcinoma
Ovarian Neoplasms
Carcinoma, Ovarian Epithelial
Fallopian Tube Neoplasms
Paclitaxel
Albumin-Bound Paclitaxel
Carboplatin
Study type:
Interventional
Study phase:
Phase 3
Overall status:
Recruiting
Study design:
Allocation:
Randomized
Intervention model:
Parallel Assignment
Primary purpose:
Other
Masking:
Double (Participant, Investigator)
Intervention:
Intervention type:
Drug
Intervention name:
nab-paclitaxel combined with carboplatin
Description:
Nab-Paclitaxel/carboplatin q3weeks Nab-Paclitaxel 260 mg/m² IV followed by carboplatin
AUC（area under the curve） 5 IV Day1 Repeat every 21 days x 6 cycles
Nab-Paclitaxel/carboplatin weekly Dose-dense Nab-Paclitaxel 100 mg/m2 IV followed by
carboplatin AUC（area under the curve）2 IV Davs 1. 8, and 15 ·Repeat every 21 days x 6
cycles Paclitaxel 175 mg/m² IV followed by carboplatin AUC（area under the curve）5 IV
Day·1Repeat every 21 days x 6 cycles
Paclitaxel weekly/carboplatin weekly Paclitaxel 60 mg/m2 followed by carboplatin AUC（area
under the curve）2 IV Days 1.8. and 15: repeat every 21 days 6 cycles (18 weeks)
Arm group label:
Nab-Paclitaxel/carboplatin for systemic therapy after surgery
Arm group label:
Paclitaxel/carboplatin for systemic therapy
Other name:
paclitaxel combined with carboplatin
Summary:
The purpose of this study is to compare the efficacy and safety of nab-paclitaxel with
solvent-based taxanes as first-line treatment for patients with advanced primary
epithelial ovarian cancer (EOC), primary peritoneal carcinoma or fallopian tube
carcinoma.
Detailed description:
One of the major challenges related to solvent-based taxanes administration in clinical
practice is the high rate of hypersensitivity reactions (HSRs). Nab-paclitaxel has showed
its considerable survival and low toxicity profiles in first-line treatment for several
solid tumors and is recommended as a treatment for recurrent epithelial ovarian cancer
(EOC). We focus on clinical efficacy and safety outcomes of nab-paclitaxel in current
clinical studies of primary EOC treatment and aim to explore the potential feasibility of
nab-paclitaxel as the first-line treatment for EOC, primary peritoneal carcinoma or
fallopian tube carcinoma.
Criteria for eligibility:
Criteria:
Inclusion Criteria:
1. Epithelial ovarian cancer/tubal cancer/peritoneal cancer was diagnosed by
histopathology or hydroexfoliation cytopathology of the chest and abdomen, and was
classified as stage III-IV according to FIGO（International Federation of Gynecology
and Obstetrics）stage
2. Physical condition Eastern Cooperative Oncology Group PS score: 0-2 points
3. Participants who had not participated in other drug clinical trials within 4 weeks
prior to enrollment
4. Written informed consent
5. Expected survival ≥6 months
6. The disease met the criteria for Efficacy Evaluation of solid tumors (RECIST 1.1)
7. Be able to comply with outpatient treatment, laboratory monitoring, and necessary
clinical visits during study participation.
Exclusion Criteria:
1. Patients with low malignant potential ovarian tumors;
2. Other malignant tumors within the previous 5 years, except for cured cervical
carcinoma in situ and non-melanoma skin cancer;
3. Patients who have previously received chemotherapy or radiotherapy for pelvic
cavity;
4. Patients with central nervous system metastasis or peripheral neuropathy > grade 1;
5. Patients with severe myelosuppression, severe liver dysfunction (Child's Class III),
or renal dysfunction at the time of screening;
6. Severe cardiovascular disease: Grade Ⅱ or above myocardial ischemia or myocardial
infarction, poorly controlled arrhythmias (including QTc interval ≥470 ms);
According to NYHA（New York Heart Association） criteria, patients with grade Ⅲ to Ⅳ
cardiac insufficiency or left ventricular ejection fraction (LVEF) < 55% indicated
by color Doppler ultrasonography;
7. Uncontrolled systemic infection requiring anti-infective treatment;
8. Arteriovenous thrombosis events occurring within 6 months before randomization, such
as cardiovascular and cerebrovascular accidents (including temporary ischemic
attack, cerebral hemorrhage, cerebral infarction, myocardial infarction), deep vein
thrombosis and pulmonary embolism;
9. Patients who are allergic to the active ingredients or excipients of albumin
paclitaxel and carboplatin for injection;
10. Pregnant or lactating women;
11. Those who were considered unsuitable for inclusion by the researchers.
Gender:
Female
Minimum age:
18 Years
Maximum age:
75 Years
Healthy volunteers:
No
Locations:
Facility:
Name:
Sun Yat-Sen University Cancer Hospital
Address:
City:
Guangzhou
Country:
China
Status:
Not yet recruiting
Contact:
Last name:
Yanling Feng
Investigator:
Last name:
Jihong Liu
Email:
Principal Investigator
Facility:
Name:
Qilu Hospital of Shandong University
Address:
City:
Ji'nan
Zip:
250012
Country:
China
Status:
Not yet recruiting
Contact:
Last name:
Jie Jiang
Email:
qljiangjie@aliyun.com
Investigator:
Last name:
Beihua Kong
Email:
Principal Investigator
Facility:
Name:
Yaxia Chen
Address:
City:
Hangzhou
Zip:
310006
Country:
China
Status:
Recruiting
Contact:
Last name:
Yang Li, Doctor
Phone:
+86-571-87061501
Email:
li_yang@zju.edu.cn
Investigator:
Last name:
Yaxia Chen
Email:
Principal Investigator
Facility:
Name:
Sir Run Run Hospital
Address:
City:
Hangzhou
Country:
China
Status:
Not yet recruiting
Contact:
Last name:
Jianhua Yang
Facility:
Name:
The First Affiliated Hospital of Medical College of Zhejiang University
Address:
City:
Hangzhou
Country:
China
Status:
Not yet recruiting
Contact:
Last name:
Jianhua Qian
Facility:
Name:
The Second Affiliated Hospital of Medical College of Zhejiang University
Address:
City:
Hangzhou
Country:
China
Status:
Not yet recruiting
Contact:
Last name:
Jianwei Zhou
Facility:
Name:
Zhejiang Cancer Hospital
Address:
City:
Hangzhou
Country:
China
Status:
Not yet recruiting
Contact:
Last name:
Yaqing Chen
Facility:
Name:
Ningbo women's and children's Hospital
Address:
City:
Ningbo
Country:
China
Status:
Not yet recruiting
Contact:
Last name:
Lingjun Zhao
Facility:
Name:
The No, 1 People's Hospital of Ningbo
Address:
City:
Ningbo
Country:
China
Status:
Not yet recruiting
Contact:
Last name:
Yutao Guan
Facility:
Name:
The Second Affiliated Hospital of Wenzhou Medical University
Address:
City:
Wenzhou
Country:
China
Status:
Not yet recruiting
Contact:
Last name:
Yan Hu
Facility:
Name:
The First Affiliated Hospital of Wenzhou Medical University
Address:
City:
Wenzhou
Country:
China
Status:
Not yet recruiting
Contact:
Last name:
Xiaojian Yan
Start date:
February 24, 2023
Completion date:
December 31, 2027
Lead sponsor:
Agency:
Women's Hospital School Of Medicine Zhejiang University
Agency class:
Other
Collaborator:
Agency:
Jiaxing Maternity and Child Health Care Hospital
Agency class:
Other
Collaborator:
Agency:
Zhejiang University
Agency class:
Other
Collaborator:
Agency:
Second Affiliated Hospital, School of Medicine, Zhejiang University
Agency class:
Other
Collaborator:
Agency:
First Affiliated Hospital of Wenzhou Medical University
Agency class:
Other
Collaborator:
Agency:
Second Affiliated Hospital of Wenzhou Medical University
Agency class:
Other
Collaborator:
Agency:
Sun Yat-sen University
Agency class:
Other
Collaborator:
Agency:
Qilu Hospital of Shandong University
Agency class:
Other
Collaborator:
Agency:
Ningbo No. 1 Hospital
Agency class:
Other
Collaborator:
Agency:
Ningbo Women & Children's Hospital
Agency class:
Other
Collaborator:
Agency:
Sir Run Run Shaw Hospital
Agency class:
Other
Source:
Women's Hospital School Of Medicine Zhejiang University
Record processing date:
ClinicalTrials.gov processed this data on November 12, 2024
Source: ClinicalTrials.gov page:
https://clinicaltrials.gov/ct2/show/NCT05737303
