Completed

AICEA Phase II,Randomized Study of an Addition Intraperitoneal Cisplatin and Etoposide to Standard First-line Therapy in Stage IIIC and Stage IV Epithelial Ovarian, Fallopian Tube, and Primary Peritoneal Cancer (EOC, FTC, PPC)

0 criteria met from your profileSee at a glance how your profile meets each eligibility criteria.
What is being tested

PEip (weekly) and TCiv

+ TCiv

Drug
Who is being recruted

Urogenital Diseases+14

+ Genital Diseases

+ Adnexal Diseases

From 18 to 75 Years
+17 Eligibility Criteria
See all eligibility criteria
How is the trial designed

Treatment Study

Phase 2
Interventional
Study Start: April 2009
See protocol details

Summary

Principal SponsorShanghai Gynecologic Oncology Group
Last updated: December 19, 2016
Sourced from a government-validated database.Claim as a partner

Study start date: April 1, 2009

Actual date on which the first participant was enrolled.

This exploratory trial is to compare the efficacy of sequential chemotherapy, intraperitoneal chemotherapy followed by intravenous chemotherapy, versus intravenous chemotherapy alone in the first-line therapy for ovarian cancer.

NCT01669226
Principal SponsorShanghai Gynecologic Oncology Group
Last updated: December 19, 2016
Sourced from a government-validated database.Claim as a partner

Protocol

This section provides details of the study plan, including how the study is designed and what the study is measuring.
Design Details

215 patients to be enrolled

Total number of participants that the clinical trial aims to recruit.

Treatment Study

These studies test new ways to treat a disease, condition, or health issue. The goal is to see if a new drug, therapy, or approach works better or has fewer side effects than existing options.

Eligibility

Researchers look for people who fit a certain description, called eligibility criteria: person's general health condition or prior treatments.
Conditions
Criteria

Female

Biological sex of participants that are eligible to enroll.

From 18 to 75 Years

Range of ages for which participants are eligible to join.

Healthy volunteers not allowed

If individuals who are healthy and do not have the condition being studied can participate.

Conditions

Pathology

Urogenital DiseasesGenital DiseasesAdnexal DiseasesEndocrine System DiseasesEndocrine Gland NeoplasmsFallopian Tube DiseasesFemale Urogenital Diseases and Pregnancy ComplicationsGenital Diseases, FemaleGenital Neoplasms, FemaleGonadal DisordersNeoplasmsNeoplasms by SiteOvarian DiseasesUrogenital NeoplasmsFemale Urogenital DiseasesFallopian Tube NeoplasmsOvarian Neoplasms

Criteria

9 inclusion criteria required to participate
Age >= 18 years to <= 75 years
Available to receive intraperitoneal chemotherapy 5-10 days postoperative, or no more than postoperative 14 days for those with bowel resection
Comply with intraperitoneal chemotherapy and follow-up
ECOG performance 0-2
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8 exclusion criteria prevent from participating
Active coronary artery disease, cerebrovascular disease, restrictive or obstructive pulmonary disease, or congestive heart failure
Active infection
Bone marrow dysfunction: absolute neutrophil count less than 1,500/mm3; Platelet count less than 80,000/mm3
Clinically significant gastrointestinal abnormalities
Show More Criteria

Study Plan

Find out more about all the medication administered in this study, their detailed description and what they involve.
Treatment Groups
Study Objectives

2 intervention groups are designated in this study

This study does not include a placebo group 

Treatment Groups

Group I

Experimental
Weekly IP cisplatin plus etoposide followed by IV paclitaxel plus carboplatin or docetaxel plus carboplatin

Group II

Active Comparator
IV paclitaxel plus carboplatin or docetaxel plus carboplatin

Study Objectives

Primary Objectives

Secondary Objectives

Study Centers

These are the hospitals, clinics, or research facilities where the trial is being conducted. You can find the location closest to you and its status.

This study has 7 locations

Zhongda Hospital Southeast University

Nanjing, ChinaOpen Zhongda Hospital Southeast University in Google Maps

Suzhou Municipal Hospital

Suzhou, China

Wuxi Cancer Hospital

Wuxi, China

Shanghai Zhongshan Hospital

Shanghai, China
Completed7 Study Centers