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

Primary Purpose

Ovarian Cancer

Status
Unknown status
Phase
Phase 3
Locations
China
Study Type
Interventional
Intervention
Doxorubicin Hydrochloride Liposome Injection+carboplatin
paclitaxel +carboplatin
Sponsored by
Hunan Cancer Hospital
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Ovarian Cancer

Eligibility Criteria

18 Years - 75 Years (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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;

Sites / Locations

  • Hunan Cancer HospitalRecruiting

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Active Comparator

Arm Label

PP

TP

Arm Description

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

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

Outcomes

Primary Outcome Measures

PFS（Progression-Free-Survival)
From the date of randomization to the time of tumor progression

Secondary Outcome Measures

OS(Overall survival)
Time from random day to death (month)
ORR( Objective response rate)
the percentage of patients whose tumors shrink a certain amount and stay that way for a certain amount of time

Full Information

First Posted
March 26, 2020
Last Updated
April 7, 2021
Sponsor
Hunan Cancer Hospital
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1. Study Identification

Unique Protocol Identification Number
NCT04337632
Brief Title
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

2. Study Status

Record Verification Date
April 2021
Overall Recruitment Status
Unknown status
Study Start Date
August 1, 2017 (Actual)
Primary Completion Date
June 2021 (Anticipated)
Study Completion Date
June 2021 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Hunan Cancer Hospital

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Ovarian Cancer

7. Study Design

Primary Purpose
Treatment
Study Phase
Phase 3
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Randomized
Enrollment
338 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
PP
Arm Type
Experimental
Arm Description
Doxorubicin Hydrochloride Liposome Injection 25mg/m2, carboplatin AUC 5, day 1, intravenous drip, repeated every three weeks.
Arm Title
TP
Arm Type
Active Comparator
Arm Description
paclitaxel 175mg/m2, carboplatin AUC 5, day 1, intravenous infusion, repeated every three weeks.
Intervention Type
Drug
Intervention Name(s)
Doxorubicin Hydrochloride Liposome Injection+carboplatin
Other Intervention Name(s)
PP
Intervention Description
Doxorubicin Hydrochloride Liposome Injection 25mg/m2, carboplatin AUC 5, first day, intravenous drip, repeated every three weeks.
Intervention Type
Drug
Intervention Name(s)
paclitaxel +carboplatin
Other Intervention Name(s)
TP
Intervention Description
paclitaxel 175mg/m2, carboplatin AUC 5, day 1, intravenous infusion, repeated every three weeks.
Primary Outcome Measure Information:
Title
PFS（Progression-Free-Survival)
Description
From the date of randomization to the time of tumor progression
Time Frame
up to 24months
Secondary Outcome Measure Information:
Title
OS(Overall survival)
Description
Time from random day to death (month)
Time Frame
up to 36months
Title
ORR( Objective response rate)
Description
the percentage of patients whose tumors shrink a certain amount and stay that way for a certain amount of time
Time Frame
up to 12 months

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
75 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria: age: 18-75 years old PS score: ECOG 0 ~ 2 histopathologically confirmed primary high-grade serous adenocarcinoma or high-grade endometrioid adenocarcinoma of the ovary, fallopian tube or peritoneum; the time interval between this recurrence and the last chemotherapy was 6-12 months; evaluate the ability of bone marrow, liver, kidney, heart and other important organ functions to withstand chemotherapy; expected survival over 3 months; sign the informed consent. Exclusion Criteria: brain metastasis or the presence of symptoms caused by brain metastasis; serious complications; acute inflammatory reaction; other tumors; a history of allergy to paclitaxel or polyropyridone liposomes;
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Jing Wang, MD.
Phone
（86-0731）88651849
Email
wangjing@hnca.org.cn
First Name & Middle Initial & Last Name or Official Title & Degree
Jing Su, MD.
Phone
（86-0731）89762815
Email
sujing@hnca.org.cn
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Jing Wang, MD.
Organizational Affiliation
Hunan Cancer Hospital
Official's Role
Study Chair
Facility Information:
Facility Name
Hunan Cancer Hospital
City
Changsha
State/Province
Hunan
ZIP/Postal Code
410013
Country
China
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Jing Wang, MD.
Phone
(86-0731)88651849
Email
wangjing@hnca.org.cn
First Name & Middle Initial & Last Name & Degree
Jing Su, MD.
Phone
(86-0731)89762815
Email
sujing@hnca.org.cn

12. IPD Sharing Statement

Learn more about this trial

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

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