Clinical trial NCT04337632: Evaluation of the Sensitivity to Different Chemotherapy Regimens in Platinum-Partial Sensitive Recurrent Ovarian Cancer
Official title: 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 type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: PHASE3
Conditions: Ovarian Cancer
Lead sponsor: Hunan Cancer Hospital
Sponsor class: OTHER
First posted: 2020-04-08
Enrollment: 338
Sex: ALL
Minimum age (years): 18
Maximum age (years): 75
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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.

Eligibility criteria: 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;

Primary outcomes:
measure: PFS（Progression-Free-Survival)
timeFrame: up to 24months
Secondary outcomes:
measure: OS(Overall survival)
timeFrame: up to 36months
measure: ORR( Objective response rate)
timeFrame: up to 12 months
Other outcomes:
Locations:
city: Changsha
country: China
facility: Hunan Cancer Hospital
state: Hunan
Study officials:
affiliation: Hunan Cancer Hospital
name: Jing Wang, MD.
role: STUDY_CHAIR
References: