Ovarian Cancer
Conditions
Brief summary
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.
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.
Interventions
DRUGDoxorubicin Hydrochloride Liposome Injection+carboplatin
Doxorubicin Hydrochloride Liposome Injection 25mg/m2, carboplatin AUC 5, first day, intravenous drip, repeated every three weeks.
DRUGpaclitaxel +carboplatin
paclitaxel 175mg/m2, carboplatin AUC 5, day 1, intravenous infusion, repeated every three weeks.
Sponsors
Hunan Cancer Hospital
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
18 Years to 75 Years
Healthy volunteers
No
Inclusion criteria
1. age: 18-75 years old 2. PS score: ECOG 0 \ 2 3. histopathologically confirmed primary high-grade serous adenocarcinoma or high-grade endometrioid adenocarcinoma of the ovary, fallopian tube or peritoneum; 4. the time interval between this recurrence and the last chemotherapy was 6-12 months; 5. evaluate the ability of bone marrow, liver, kidney, heart and other important organ functions to withstand chemotherapy; 6. expected survival over 3 months; 7. sign the informed consent.
Exclusion criteria
1. brain metastasis or the presence of symptoms caused by brain metastasis; 2. serious complications; 3. acute inflammatory reaction; 4. other tumors; 5. a history of allergy to paclitaxel or polyropyridone liposomes;
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| PFS（Progression-Free-Survival) | up to 24months | From the date of randomization to the time of tumor progression |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| OS(Overall survival) | up to 36months | Time from random day to death (month) |
| ORR( Objective response rate) | up to 12 months | the percentage of patients whose tumors shrink a certain amount and stay that way for a certain amount of time |
Countries
China
Contacts
Primary ContactJing Wang, MD.
Backup ContactJing Su, MD.
Outcome results
None listed