Back to resultsNab-paclitaxel Versus Sb-taxanes As First-Line Treatment in Advanced Ovarian Cancer
Primary Purpose
Epithelial Ovarian Carcinoma Stage III, Epithelial Ovarian Carcinoma Stage IV, Fallopian Tube Carcinoma Stage III
Status
Recruiting
Phase
Phase 3
Locations
China
Study Type
Interventional
Intervention
nab-paclitaxel combined with carboplatin
Sponsored by
About this trial
This is an interventional other trial for Epithelial Ovarian Carcinoma Stage III
Eligibility Criteria
Inclusion Criteria: 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 Physical condition Eastern Cooperative Oncology Group PS score: 0-2 points Participants who had not participated in other drug clinical trials within 4 weeks prior to enrollment Written informed consent Expected survival ≥6 months The disease met the criteria for Efficacy Evaluation of solid tumors (RECIST 1.1) Be able to comply with outpatient treatment, laboratory monitoring, and necessary clinical visits during study participation. Exclusion Criteria: Patients with low malignant potential ovarian tumors; Other malignant tumors within the previous 5 years, except for cured cervical carcinoma in situ and non-melanoma skin cancer; Patients who have previously received chemotherapy or radiotherapy for pelvic cavity; Patients with central nervous system metastasis or peripheral neuropathy > grade 1; Patients with severe myelosuppression, severe liver dysfunction (Child's Class III), or renal dysfunction at the time of screening; 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; Uncontrolled systemic infection requiring anti-infective treatment; 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; Patients who are allergic to the active ingredients or excipients of albumin paclitaxel and carboplatin for injection; Pregnant or lactating women; Those who were considered unsuitable for inclusion by the researchers.
Sites / Locations
- Sun Yat-Sen University Cancer Hospital
- Qilu Hospital of Shandong University
- Yaxia ChenRecruiting
- Sir Run Run Hospital
- The First Affiliated Hospital of Medical College of Zhejiang University
- The Second Affiliated Hospital of Medical College of Zhejiang University
- Zhejiang Cancer Hospital
- Ningbo women's and children's Hospital
- The No, 1 People's Hospital of Ningbo
- The Second Affiliated Hospital of Wenzhou Medical University
- The First Affiliated Hospital of Wenzhou Medical University
Arms of the Study
Arm 1
Arm 2
Arm Type
Experimental
Active Comparator
Arm Label
Nab-Paclitaxel/carboplatin for systemic therapy after surgery
Paclitaxel/carboplatin for systemic therapy
Arm Description
Nab-Paclitaxel/carboplatin q3 weeks 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)
Outcomes
Primary Outcome Measures
Progression Free Survival
Disease progression as first failure
Secondary Outcome Measures
Objective Remission Rate
The target lesion disappeared for at least 4 weeks,Tumor volume reduced by at least 30 percent.
Survival
Overall survival (all-cause death)
Adverse events
Treatment-related symptoms
Full Information
NCT ID
NCT05737303
First Posted
January 2, 2023
Last Updated
February 19, 2023
Sponsor
Women's Hospital School Of Medicine Zhejiang University
Collaborators
Jiaxing Maternity and Child Health Care Hospital, Zhejiang University, Second Affiliated Hospital, School of Medicine, Zhejiang University, First Affiliated Hospital of Wenzhou Medical University, Second Affiliated Hospital of Wenzhou Medical University, Sun Yat-sen University, Qilu Hospital of Shandong University, Ningbo No. 1 Hospital, Ningbo Women & Children's Hospital, Sir Run Run Shaw Hospital
1. Study Identification
Unique Protocol Identification Number
NCT05737303
Brief Title
Nab-paclitaxel Versus Sb-taxanes As First-Line Treatment in Advanced Ovarian Cancer
Official Title
Nab-paclitaxel Versus Solvent-based Taxanes As First-Line Treatment for Patients With Advanced Ovarian Cancer
Study Type
Interventional
2. Study Status
Record Verification Date
February 2023
Overall Recruitment Status
Recruiting
Study Start Date
February 24, 2023 (Anticipated)
Primary Completion Date
December 31, 2024 (Anticipated)
Study Completion Date
December 31, 2027 (Anticipated)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Women's Hospital School Of Medicine Zhejiang University
Collaborators
Jiaxing Maternity and Child Health Care Hospital, Zhejiang University, Second Affiliated Hospital, School of Medicine, Zhejiang University, First Affiliated Hospital of Wenzhou Medical University, Second Affiliated Hospital of Wenzhou Medical University, Sun Yat-sen University, Qilu Hospital of Shandong University, Ningbo No. 1 Hospital, Ningbo Women & Children's Hospital, Sir Run Run Shaw Hospital
4. Oversight
Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
Yes
5. Study Description
Brief 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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
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
7. Study Design
Primary Purpose
Other
Study Phase
Phase 3
Interventional Study Model
Parallel Assignment
Masking
ParticipantInvestigator
Allocation
Randomized
Enrollment
538 (Anticipated)
8. Arms, Groups, and Interventions
Arm Title
Nab-Paclitaxel/carboplatin for systemic therapy after surgery
Arm Type
Experimental
Arm Description
Nab-Paclitaxel/carboplatin q3 weeks 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
Arm Title
Paclitaxel/carboplatin for systemic therapy
Arm Type
Active Comparator
Arm Description
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)
Intervention Type
Drug
Intervention Name(s)
nab-paclitaxel combined with carboplatin
Other Intervention Name(s)
paclitaxel combined with carboplatin
Intervention 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)
Primary Outcome Measure Information:
Title
Progression Free Survival
Description
Disease progression as first failure
Time Frame
20 months
Secondary Outcome Measure Information:
Title
Objective Remission Rate
Description
The target lesion disappeared for at least 4 weeks,Tumor volume reduced by at least 30 percent.
Time Frame
12 months
Title
Survival
Description
Overall survival (all-cause death)
Time Frame
3 years, 5 years
Title
Adverse events
Description
Treatment-related symptoms
Time Frame
3 years, 5 years
10. Eligibility
Sex
Female
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
75 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria:
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
Physical condition Eastern Cooperative Oncology Group PS score: 0-2 points
Participants who had not participated in other drug clinical trials within 4 weeks prior to enrollment
Written informed consent
Expected survival ≥6 months
The disease met the criteria for Efficacy Evaluation of solid tumors (RECIST 1.1)
Be able to comply with outpatient treatment, laboratory monitoring, and necessary clinical visits during study participation.
Exclusion Criteria:
Patients with low malignant potential ovarian tumors;
Other malignant tumors within the previous 5 years, except for cured cervical carcinoma in situ and non-melanoma skin cancer;
Patients who have previously received chemotherapy or radiotherapy for pelvic cavity;
Patients with central nervous system metastasis or peripheral neuropathy > grade 1;
Patients with severe myelosuppression, severe liver dysfunction (Child's Class III), or renal dysfunction at the time of screening;
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;
Uncontrolled systemic infection requiring anti-infective treatment;
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;
Patients who are allergic to the active ingredients or excipients of albumin paclitaxel and carboplatin for injection;
Pregnant or lactating women;
Those who were considered unsuitable for inclusion by the researchers.
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Yaxia Chen, MD
Phone
+86-571-87061501
Email
chenyax@zju.edu.cn
First Name & Middle Initial & Last Name or Official Title & Degree
Yang Li, MD
Phone
+86-571-87061501
Email
li_yang@zju.edu.cn
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Yaxia Chen, MD
Organizational Affiliation
Study Principal Investigator
Official's Role
Principal Investigator
Facility Information:
Facility Name
Sun Yat-Sen University Cancer Hospital
City
Guangzhou
State/Province
Guangdong
Country
China
Individual Site Status
Not yet recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Yanling Feng
First Name & Middle Initial & Last Name & Degree
Jihong Liu
Facility Name
Qilu Hospital of Shandong University
City
Ji'nan
State/Province
Shandong
ZIP/Postal Code
250012
Country
China
Individual Site Status
Not yet recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Jie Jiang
Email
qljiangjie@aliyun.com
First Name & Middle Initial & Last Name & Degree
Beihua Kong
Facility Name
Yaxia Chen
City
Hangzhou
State/Province
Zhejiang
ZIP/Postal Code
310006
Country
China
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Yang Li, Doctor
Phone
+86-571-87061501
Email
li_yang@zju.edu.cn
First Name & Middle Initial & Last Name & Degree
Yaxia Chen
Facility Name
Sir Run Run Hospital
City
Hangzhou
State/Province
Zhejiang
Country
China
Individual Site Status
Not yet recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Jianhua Yang
Facility Name
The First Affiliated Hospital of Medical College of Zhejiang University
City
Hangzhou
State/Province
Zhejiang
Country
China
Individual Site Status
Not yet recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Jianhua Qian
Facility Name
The Second Affiliated Hospital of Medical College of Zhejiang University
City
Hangzhou
State/Province
Zhejiang
Country
China
Individual Site Status
Not yet recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Jianwei Zhou
Facility Name
Zhejiang Cancer Hospital
City
Hangzhou
State/Province
Zhejiang
Country
China
Individual Site Status
Not yet recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Yaqing Chen
Facility Name
Ningbo women's and children's Hospital
City
Ningbo
State/Province
Zhejiang
Country
China
Individual Site Status
Not yet recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Lingjun Zhao
Facility Name
The No, 1 People's Hospital of Ningbo
City
Ningbo
State/Province
Zhejiang
Country
China
Individual Site Status
Not yet recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Yutao Guan
Facility Name
The Second Affiliated Hospital of Wenzhou Medical University
City
Wenzhou
State/Province
Zhejiang
Country
China
Individual Site Status
Not yet recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Yan Hu
Facility Name
The First Affiliated Hospital of Wenzhou Medical University
City
Wenzhou
Country
China
Individual Site Status
Not yet recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Xiaojian Yan
12. IPD Sharing Statement
Plan to Share IPD
No
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Nab-paclitaxel Versus Sb-taxanes As First-Line Treatment in Advanced Ovarian Cancer
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