NCT01570582

Brief Summary

purpose Primary endpoint

  • To evaluate the 24 month disease free survival Second endpoints
  • To evaluate the 24 month overall survival To analyze the toxicity and the quality of life

Trial Health

43
At Risk

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Trial has exceeded expected completion date
Enrollment
314

participants targeted

Target at P75+ for phase_2

Timeline
Completed

Started Mar 2010

Typical duration for phase_2

Geographic Reach
1 country

1 active site

Status
unknown

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

March 1, 2010

Completed
2 years until next milestone

First Submitted

Initial submission to the registry

March 14, 2012

Completed
21 days until next milestone

First Posted

Study publicly available on registry

April 4, 2012

Completed
1.9 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

March 1, 2014

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

March 1, 2014

Completed
Last Updated

April 4, 2012

Status Verified

April 1, 2012

Enrollment Period

4 years

First QC Date

March 14, 2012

Last Update Submit

April 3, 2012

Conditions

Fallopian Tube CancerOvarian CancerPrimary Peritoneal Cancer

Keywords

recurrent ovarianECGGOG performanceHematologic gBlood chemistry and urinalysis h

Outcome Measures

Primary Outcomes (1)

  • 24month progression free survival

    24 months

Secondary Outcomes (1)

  • Toxicity Profile

    24 months

Study Arms (1)

drug effect

EXPERIMENTAL

Subjects assigned to Arm I Neople taksoljuwa Latin week the first day of the week based outpatient / inpatient treatment receive it. The subjects first received taksoljureul given over 3 hours followed by 30 minutes will be administered Neople Latin week. Subjects assigned to Arm II Gemcitabine and Latin Neople every week based on the first day of the outpatient / inpatient treatment receive it. The subjects first received Gemcitabine given over 30 minutes followed by 30 minutes will be administered Neople Latin week. Gemcitabine and eighth day of the foreign / hospitalization are given over 30 minutes. Regimen of the progression of the disease, the subject can not continue to deny or toxic dose every 3 weeks until at least 6 cycles should be administered to. Subjects completed six cycles of medication which responds subjects, the researchers believe it is necessary to sustain if the regimen is

Drug: carboplatin and paclitaxel

Interventions

carboplatin and paclitaxelDRUG

Subjects assigned to Arm I Neople taksoljuwa Latin week the first day of the week based outpatient / inpatient treatment receive it. The subjects first received taksoljureul given over 3 hours followed by 30 minutes will be administered Neople Latin week.

Also known as: carboplatin , paclitaxel and Gemcitabine
drug effect

Eligibility Criteria

Age18 Years - 70 Years
Sexfemale
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • Patients with epithelial ovarian, fallopian tube cancer bokmakam or pathological diagnosis of recurrent states there must be must be present.
  • Pathologically Serous adenocarcinoma, endometrioid adenocarcinoma, mucinous adenocarcinoma, undifferentiated carcinoma, clear cell adenocarcinoma, mixed epithelial carcinoma, transitional cell carcinoma, malignant Brenner's Tumor, or adenocarcinoma not otherwise specified (NOS) have been diagnosed with possible participation.
  • Patients with CA-125 (biochemical recurrence), as described below elevation or clinically measurable lesions or the measurement is not possible, as there should be evidence of recurrence.
  • If at least one (record as the longest diameter) can be accurately measured in at least one lesion that is defined. For each lesion, such as MRI or CT, when measured by traditional methods should be at least 20mm spiral CT (spiral CT) have been measured to be less than 10mm when.
  • Neutrophil (ANC) by 1500 / ㎣ more Platelet count 100,000 / ㎣ more Serum creatinine concentration 1.5mg/dL (133mol / l) or creatinine clearance less than 60ml/min should be at least two.

You may not qualify if:

  • Patients must be at least 18 years of age.
  • Patients with epithelial ovarian, fallopian tube cancer bokmakam or pathological diagnosis of recurrent states there must be must be present.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Korea Institute of Radiological and Medical Sciences

Seoul, South Korea

Location

MeSH Terms

Conditions

Fallopian Tube NeoplasmsOvarian Neoplasms

Interventions

CarboplatinPaclitaxelGemcitabine

Condition Hierarchy (Ancestors)

Genital Neoplasms, FemaleUrogenital NeoplasmsNeoplasms by SiteNeoplasmsFallopian Tube DiseasesAdnexal DiseasesGenital Diseases, FemaleFemale Urogenital DiseasesFemale Urogenital Diseases and Pregnancy ComplicationsUrogenital DiseasesGenital DiseasesEndocrine Gland NeoplasmsOvarian DiseasesEndocrine System DiseasesGonadal Disorders

Intervention Hierarchy (Ancestors)

Coordination ComplexesOrganic ChemicalsTaxoidsCyclodecanesCycloparaffinsHydrocarbons, AlicyclicHydrocarbons, CyclicHydrocarbonsDiterpenesTerpenesHeterocyclic CompoundsDeoxycytidineCytidinePyrimidine NucleosidesPyrimidinesHeterocyclic Compounds, 1-Ring

Study Design

Study Type
interventional
Phase
phase 2
Allocation
NA
Masking
NONE
Purpose
TREATMENT
Intervention Model
SINGLE GROUP
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Principal Investigator

Study Record Dates

First Submitted

March 14, 2012

First Posted

April 4, 2012

Study Start

March 1, 2010

Primary Completion

March 1, 2014

Study Completion

March 1, 2014

Last Updated

April 4, 2012

Record last verified: 2012-04

Locations

KR(1)