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

Phase 3

• Conditions: Ovarian Cancer
• Interventions: Drug: paclitaxel +carboplatin; Drug: Doxorubicin Hydrochloride Liposome Injection+carboplatin

• Registration Number: NCT04337632
• Lead Sponsor: Hunan Cancer Hospital

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.

Study Timeline

• Study Start: 2017-08-01
• Study First Submitted: 2020-03-26
• Study First Submitted QC: 2020-04-06
• Study First Posted: 2020-04-08
• Status Verified: 2021-04
• Last Update Submitted: 2021-04-07
• Last Update Posted: 2021-04-08
• Primary Completion: 2021-06
• Study Completion: 2021-06

Recruitment & Eligibility

• Status: UNKNOWN
• Sex: All
• Target Recruitment: 338

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.

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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;

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Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
TP	paclitaxel +carboplatin	paclitaxel 175mg/m2, carboplatin AUC 5, day 1, intravenous infusion, repeated every three weeks.
PP	Doxorubicin Hydrochloride Liposome Injection+carboplatin	Doxorubicin Hydrochloride Liposome Injection 25mg/m2, carboplatin AUC 5, day 1, intravenous drip, repeated every three weeks.

Primary Outcome Measures

Name	Time	Method
PFS（Progression-Free-Survival)	up to 24months	From the date of randomization to the time of tumor progression

Secondary Outcome Measures

Name	Time	Method
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

Trial Locations

Locations (1)

Hunan Cancer Hospital; 🇨🇳 Changsha, Hunan, China