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

NCT04337632 | Unknown Phase 3

• 1 other identifier: 2016YFC1303703
• Study Type: interventional
• Target: 338
• Locations: 1 country
• Sites: 1

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.

Conditions

Ovarian Cancer

Outcome Measures

Primary Outcomes (1)

• PFS（Progression-Free-Survival)

  From the date of randomization to the time of tumor progression

  up to 24months

Secondary Outcomes (2)

• OS(Overall survival)

  up to 36months

• ORR( Objective response rate)

  up to 12 months

Study Arms (2)

PP

EXPERIMENTAL

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

Drug: Doxorubicin Hydrochloride Liposome Injection+carboplatin

TP

ACTIVE COMPARATOR

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

Drug: paclitaxel +carboplatin

Interventions

Doxorubicin Hydrochloride Liposome Injection+carboplatin DRUG

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

Also known as: PP

PP

paclitaxel +carboplatin DRUG

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

Also known as: TP

TP

Eligibility Criteria

• Age: 18 Years - 75 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• 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;

Sponsors & Collaborators

• Hunan Cancer Hospital: lead

Study Sites (1)

Hunan Cancer Hospital

Changsha, Hunan, 410013, China

RECRUITING

MeSH Terms

Conditions

Ovarian Neoplasms

Interventions

CP protocol

Condition Hierarchy (Ancestors)

Endocrine Gland Neoplasms; Neoplasms by Site; Neoplasms; Ovarian Diseases; Adnexal Diseases; Genital Diseases, Female; Female Urogenital Diseases; Female Urogenital Diseases and Pregnancy Complications; Urogenital Diseases; Genital Neoplasms, Female; Urogenital Neoplasms; Genital Diseases; Endocrine System Diseases; Gonadal Disorders

Study Officials

• Jing Wang, MD.

  Hunan Cancer Hospital

  STUDY CHAIR

Central Study Contacts

Jing Wang, MD.

CONTACT

（86-0731）88651849; wangjing@hnca.org.cn

Jing Su, MD.

CONTACT

（86-0731）89762815; sujing@hnca.org.cn

Study Design

• Study Type: interventional
• Phase: phase 3
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Professor

Study Record Dates

• First Submitted: March 26, 2020
• First Posted: April 8, 2020
• Study Start: August 1, 2017
• Primary Completion: June 1, 2021
• Study Completion: June 1, 2021
• Last Updated: April 8, 2021

Record last verified: 2021-04

Locations

CN (1)