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

Ovarian Cancer Clinical Trial

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

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT04337632
• Other study ID #: 2016YFC1303703
• Status: Recruiting
• Phase: Phase 3
• Start date: August 1, 2017
• Est. completion date: June 2021

Study information

• Verified date: April 2021
• Source: Hunan Cancer Hospital
• Contact: Jing Wang, MD.
• Phone: (86-0731)88651849
• Email: wangjing[@]hnca.org.cn
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 338
• Est. completion date: June 2021
• Est. primary completion date: June 2021
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years to 75 Years

Eligibility

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;

Related Conditions & MeSH terms

• Carcinoma, Ovarian Epithelial
• Ovarian Cancer
• Ovarian Neoplasms

Intervention

Drug:
• Doxorubicin Hydrochloride Liposome Injection+carboplatin
Doxorubicin Hydrochloride Liposome Injection 25mg/m2, carboplatin AUC 5, first day, intravenous drip, repeated every three weeks.
• paclitaxel +carboplatin
paclitaxel 175mg/m2, carboplatin AUC 5, day 1, intravenous infusion, repeated every three weeks.

Locations

Country	Name	City	State
China	Hunan Cancer Hospital	Changsha	Hunan

Sponsors (1)

Lead Sponsor	Collaborator
Hunan Cancer Hospital

Country where clinical trial is conducted

China, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	PFS(Progression-Free-Survival)	From the date of randomization to the time of tumor progression	up to 24months
Secondary	OS(Overall survival)	Time from random day to death (month)	up to 36months
Secondary	ORR( Objective response rate)	the percentage of patients whose tumors shrink a certain amount and stay that way for a certain amount of time	up to 12 months