- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT04337632
Evaluation of the Sensitivity to Different Chemotherapy Regimens in Platinum-Partial Sensitive Recurrent Ovarian Cancer
April 7, 2021 updated by: JingWang, Hunan Cancer Hospital
Evaluation of the Sensitivity to Different Chemotherapy Regimens in Platinum-Partial Sensitive Recurrent Ovarian Cancer Based on 11 Gene Tests of Homologous Recombination Pathway
Multicenter, prospective, randomized studies.Evaluation of the sensitivity to different chemotherapy regimens in platinum-partial sensitive recurrent ovarian cancer based on 11 gene tests of homologous recombination pathway.
Study Overview
Status
Recruiting
Conditions
Intervention / Treatment
Detailed Description
Patients meeting the following inclusion criteria were randomly divided into two groups in a 1:1 ratio: paclitaxel/platinum chemotherapy group (TP) and Doxorubicin Hydrochloride Liposome Injection/platinum chemotherapy group (PP) (the specific chemotherapy regimens are as follows.Chemotherapy to tumor progression or adverse reactions can not be tolerated, effective chemotherapy patients with a maximum of 6 cycles of chemotherapy.The primary endpoint was progression-free survival (PFS), and the secondary endpoints were safety and overall survival.Also USES the next-generation sequencing (NGS) method to detect patients with recurrence after tumor tissues (including chest, ascites, homologous recombination pathway in the tumor tissue and peripheral blood ctDNA 11 genetic mutations, rearrangement, and so on and so forth, whether patients with analysing the homologous recombination pathways for paclitaxel/platinum chemotherapy or Doxorubicin Hydrochloride Liposome Injection/platinum chemotherapy has different sensitivity.
Study Type
Interventional
Enrollment (Anticipated)
338
Phase
- Phase 3
Contacts and Locations
This section provides the contact details for those conducting the study, and information on where this study is being conducted.
Study Contact
- Name: Jing Wang, MD.
- Phone Number: (86-0731)88651849
- Email: wangjing@hnca.org.cn
Study Contact Backup
- Name: Jing Su, MD.
- Phone Number: (86-0731)89762815
- Email: sujing@hnca.org.cn
Study Locations
-
-
Hunan
-
Changsha, Hunan, China, 410013
- Recruiting
- Hunan Cancer hospital
-
Contact:
- Jing Wang, MD.
- Phone Number: (86-0731)88651849
- Email: wangjing@hnca.org.cn
-
Contact:
- Jing Su, MD.
- Phone Number: (86-0731)89762815
- Email: sujing@hnca.org.cn
-
-
Participation Criteria
Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.
Eligibility Criteria
Ages Eligible for Study
18 years to 75 years (Adult, Older Adult)
Accepts Healthy Volunteers
No
Genders Eligible for Study
All
Description
Inclusion Criteria:
- age: 18-75 years old
- PS score: ECOG 0 ~ 2
- histopathologically confirmed primary high-grade serous adenocarcinoma or high-grade endometrioid adenocarcinoma of the ovary, fallopian tube or peritoneum;
- the time interval between this recurrence and the last chemotherapy was 6-12 months;
- evaluate the ability of bone marrow, liver, kidney, heart and other important organ functions to withstand chemotherapy;
- expected survival over 3 months;
- sign the informed consent.
Exclusion Criteria:
- brain metastasis or the presence of symptoms caused by brain metastasis;
- serious complications;
- acute inflammatory reaction;
- other tumors;
- a history of allergy to paclitaxel or polyropyridone liposomes;
Study Plan
This section provides details of the study plan, including how the study is designed and what the study is measuring.
How is the study designed?
Design Details
- Primary Purpose: Treatment
- Allocation: Randomized
- Interventional Model: Parallel Assignment
- Masking: None (Open Label)
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
---|---|
Experimental: PP
Doxorubicin Hydrochloride Liposome Injection 25mg/m2, carboplatin AUC 5, day 1, intravenous drip, repeated every three weeks.
|
Doxorubicin Hydrochloride Liposome Injection 25mg/m2, carboplatin AUC 5, first day, intravenous drip, repeated every three weeks.
Other Names:
|
Active Comparator: TP
paclitaxel 175mg/m2, carboplatin AUC 5, day 1, intravenous infusion, repeated every three weeks.
|
paclitaxel 175mg/m2, carboplatin AUC 5, day 1, intravenous infusion, repeated every three weeks.
Other Names:
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
PFS(Progression-Free-Survival)
Time Frame: up to 24months
|
From the date of randomization to the time of tumor progression
|
up to 24months
|
Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
OS(Overall survival)
Time Frame: up to 36months
|
Time from random day to death (month)
|
up to 36months
|
ORR( Objective response rate)
Time Frame: up to 12 months
|
the percentage of patients whose tumors shrink a certain amount and stay that way for a certain amount of time
|
up to 12 months
|
Collaborators and Investigators
This is where you will find people and organizations involved with this study.
Sponsor
Investigators
- Study Chair: Jing Wang, MD., Hunan Cancer hospital
Study record dates
These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.
Study Major Dates
Study Start (Actual)
August 1, 2017
Primary Completion (Anticipated)
June 1, 2021
Study Completion (Anticipated)
June 1, 2021
Study Registration Dates
First Submitted
March 26, 2020
First Submitted That Met QC Criteria
April 6, 2020
First Posted (Actual)
April 8, 2020
Study Record Updates
Last Update Posted (Actual)
April 8, 2021
Last Update Submitted That Met QC Criteria
April 7, 2021
Last Verified
April 1, 2021
More Information
Terms related to this study
Additional Relevant MeSH Terms
- Neoplasms by Histologic Type
- Neoplasms
- Urogenital Neoplasms
- Neoplasms by Site
- Carcinoma
- Neoplasms, Glandular and Epithelial
- Genital Neoplasms, Female
- Endocrine System Diseases
- Ovarian Diseases
- Adnexal Diseases
- Gonadal Disorders
- Endocrine Gland Neoplasms
- Ovarian Neoplasms
- Carcinoma, Ovarian Epithelial
- Molecular Mechanisms of Pharmacological Action
- Enzyme Inhibitors
- Antineoplastic Agents
- Tubulin Modulators
- Antimitotic Agents
- Mitosis Modulators
- Antineoplastic Agents, Phytogenic
- Topoisomerase II Inhibitors
- Topoisomerase Inhibitors
- Antibiotics, Antineoplastic
- Carboplatin
- Paclitaxel
- Doxorubicin
- Liposomal doxorubicin
Other Study ID Numbers
- 2016YFC1303703
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
No
Studies a U.S. FDA-regulated device product
No
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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