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

Evaluation of the Sensitivity to Different Chemotherapy Regimens in Platinum-Partial Sensitive Recurrent Ovarian Cancer Based on 11 Gene Tests of Homologous Recombination Pathway

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.

Study Overview

• Status: Recruiting
• Conditions: Ovarian Cancer
• Intervention / Treatment: Drug: Doxorubicin Hydrochloride Liposome Injection+carboplatin; Drug: paclitaxel +carboplatin

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 Type: Interventional
• Enrollment (Anticipated): 338
• Phase: Phase 3

Contacts and Locations

• Study Contact: Name: Jing Wang, MD.; Phone Number: (86-0731)88651849; Email: wangjing@hnca.org.cn
• Study Contact Backup: Name: Jing Su, MD.; Phone Number: (86-0731)89762815; Email: sujing@hnca.org.cn

Study Locations

• China
  • Hunan
    • Changsha, Hunan, China, 410013
      • Recruiting
      • Hunan Cancer Hospital
      • Contact: Jing Wang, MD.; Phone Number: (86-0731)88651849; Email: wangjing@hnca.org.cn
      • Contact: Jing Su, MD.; Phone Number: (86-0731)89762815; Email: sujing@hnca.org.cn

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years to 75 years (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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;

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: None (Open Label)

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: PP; Doxorubicin Hydrochloride Liposome Injection 25mg/m2, carboplatin AUC 5, day 1, intravenous drip, repeated every three weeks.	Drug: Doxorubicin Hydrochloride Liposome Injection+carboplatin; Doxorubicin Hydrochloride Liposome Injection 25mg/m2, carboplatin AUC 5, first day, intravenous drip, repeated every three weeks.; Other Names: PP
Active Comparator: TP; paclitaxel 175mg/m2, carboplatin AUC 5, day 1, intravenous infusion, repeated every three weeks.	Drug: paclitaxel +carboplatin; paclitaxel 175mg/m2, carboplatin AUC 5, day 1, intravenous infusion, repeated every three weeks.; Other Names: TP

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
PFS（Progression-Free-Survival)	From the date of randomization to the time of tumor progression	up to 24months

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
OS(Overall survival)	Time from random day to death (month)	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	up to 12 months

Collaborators and Investigators

• Sponsor: Hunan Cancer Hospital
• Investigators: Study Chair: Jing Wang, MD., Hunan Cancer Hospital

Study record dates

Study Major Dates

• Study Start (Actual): August 1, 2017
• Primary Completion (Anticipated): June 1, 2021
• Study Completion (Anticipated): June 1, 2021

Study Registration Dates

• First Submitted: March 26, 2020
• First Submitted That Met QC Criteria: April 6, 2020
• First Posted (Actual): April 8, 2020

Study Record Updates

• Last Update Posted (Actual): April 8, 2021
• Last Update Submitted That Met QC Criteria: April 7, 2021
• Last Verified: April 1, 2021

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Neoplasms by Histologic Type; Neoplasms; Urogenital Neoplasms; Neoplasms by Site; Carcinoma; Neoplasms, Glandular and Epithelial; Genital Neoplasms, Female; Endocrine System Diseases; Ovarian Diseases; Adnexal Diseases; Gonadal Disorders; Endocrine Gland Neoplasms; Ovarian Neoplasms; Carcinoma, Ovarian Epithelial; Molecular Mechanisms of Pharmacological Action; Enzyme Inhibitors; Antineoplastic Agents; Tubulin Modulators; Antimitotic Agents; Mitosis Modulators; Antineoplastic Agents, Phytogenic; Topoisomerase II Inhibitors; Topoisomerase Inhibitors; Antibiotics, Antineoplastic; Carboplatin; Paclitaxel; Doxorubicin; Liposomal doxorubicin
• Other Study ID Numbers: 2016YFC1303703

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No