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

NCT ID: NCT04337632

Last Updated: 2021-04-08

Basic Information

• Recruitment Status: UNKNOWN
• Clinical Phase: PHASE3
• Total Enrollment: 338 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2017-08-01
• Study Completion Date: 2021-06-30

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.

Conditions

Ovarian Cancer

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: NONE

Study Groups

PP

Doxorubicin Hydrochloride Liposome Injection 25mg/m2, carboplatin AUC 5, day 1, intravenous drip, repeated every three weeks.

Group Type: EXPERIMENTAL

Doxorubicin Hydrochloride Liposome Injection+carboplatin

Intervention Type: DRUG

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

TP

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

Group Type: ACTIVE_COMPARATOR

paclitaxel +carboplatin

Intervention Type: DRUG

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

Interventions

Doxorubicin Hydrochloride Liposome Injection+carboplatin

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

Intervention Type: DRUG

paclitaxel +carboplatin

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

Intervention Type: DRUG

Other Intervention Names

PP; TP

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;

• Minimum Eligible Age: 18 Years
• Maximum Eligible Age: 75 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Hunan Cancer Hospital

OTHER

Sponsor Role: lead

Responsible Party

JingWang

Professor

Responsibility Role: PRINCIPAL_INVESTIGATOR

Principal Investigators

Jing Wang, MD.

Role: STUDY_CHAIR

Hunan Cancer Hospital

Locations

Hunan Cancer Hospital

Changsha, Hunan, China

Site Status: RECRUITING

Countries

China

Central Contacts

Jing Wang, MD.

Role: CONTACT

wangjing@hnca.org.cn

（86-0731）88651849

Jing Su, MD.

Role: CONTACT

sujing@hnca.org.cn

（86-0731）89762815

Facility Contacts

Jing Wang, MD.

Role: primary

wangjing@hnca.org.cn

(86-0731)88651849

Jing Su, MD.

Role: backup

sujing@hnca.org.cn

(86-0731)89762815

Other Identifiers

2016YFC1303703

Identifier Type: -

Identifier Source: org_study_id