Evaluation of the Sensitivity to Different Chemotherapy Regimens in Platinum-Partial Sensitive Recurrent Ovarian Cancer

Hunan Cancer Hospital338 enrolled

Overview

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.

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

Allocation

RANDOMIZED

Purpose

TREATMENT

Masking

NONE

Enrollment

338

Conditions

Ovarian Cancer

Interventions

Doxorubicin Hydrochloride Liposome Injection+carboplatinDRUG

Doxorubicin Hydrochloride Liposome Injection 25mg/m2, carboplatin AUC 5, first day, intravenous drip, repeated every three weeks.

paclitaxel +carboplatinDRUG

paclitaxel 175mg/m2, carboplatin AUC 5, day 1, intravenous infusion, repeated every three weeks.

Eligibility

Sex: ALLMin age: 18 YearsMax age: 75 Years

Medical Language ↔ Plain English

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;

Locations (1)

Hunan Cancer Hospital

Changsha, Hunan, China

RECRUITING

Outcomes

Primary Outcomes

PFS（Progression-Free-Survival)

From the date of randomization to the time of tumor progression

Time frame: up to 24months

Secondary Outcomes

OS(Overall survival)

Time from random day to death (month)

Time frame: up to 36months

ORR( Objective response rate)

the percentage of patients whose tumors shrink a certain amount and stay that way for a certain amount of time

Time frame: up to 12 months

Central Contacts

Jing Wang, MD.

CONTACT

（86-0731）88651849 wangjing@hnca.org.cn

Jing Su, MD.

CONTACT

（86-0731）89762815 sujing@hnca.org.cn

Data from ClinicalTrials.gov

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