Working...
ClinicalTrials.gov
ClinicalTrials.gov Menu
Trial record 41 of 527 for:    "Primary Peritoneal Carcinoma"

A Phase IIclinical Trial of Carboplatin and Paclitaxel or Carboplatin and Gemcitabine in Platinum-sensitive, Recurrent Ovarian, Fallopian Tube, and Primary Peritoneal Cancer

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
ClinicalTrials.gov Identifier: NCT01570582
Recruitment Status : Unknown
Verified April 2012 by Taek Sang Lee, Korean Gynecologic Oncology Group.
Recruitment status was:  Active, not recruiting
First Posted : April 4, 2012
Last Update Posted : April 4, 2012
Sponsor:
Information provided by (Responsible Party):
Taek Sang Lee, Korean Gynecologic Oncology Group

Tracking Information
First Submitted Date  ICMJE March 14, 2012
First Posted Date  ICMJE April 4, 2012
Last Update Posted Date April 4, 2012
Study Start Date  ICMJE March 2010
Estimated Primary Completion Date March 2014   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures  ICMJE
 (submitted: April 3, 2012)
24month progression free survival [ Time Frame: 24 months ]
Original Primary Outcome Measures  ICMJE Same as current
Change History No Changes Posted
Current Secondary Outcome Measures  ICMJE
 (submitted: April 3, 2012)
Toxicity Profile [ Time Frame: 24 months ]
Original Secondary Outcome Measures  ICMJE Same as current
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title  ICMJE A Phase IIclinical Trial of Carboplatin and Paclitaxel or Carboplatin and Gemcitabine in Platinum-sensitive, Recurrent Ovarian, Fallopian Tube, and Primary Peritoneal Cancer
Official Title  ICMJE A Phase II Randomized Controlled Clinical Trial of Carboplatin and Paclitaxel or Carboplatin and Gemcitabine in Platinum-sensitive, Recurrent Ovarian, Fallopian Tube, and Primary Peritoneal Cancer
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
Detailed Description

Approximately 48 month from the date of IRB approval

Patients enrolled in this study targets approximately 314 people. Completion of patient enrollment is expected to take approximately 24 month, approximately 24 month follow-up period is expected to be needed

Study Type  ICMJE Interventional
Study Phase  ICMJE Phase 2
Study Design  ICMJE Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Condition  ICMJE
  • Fallopian Tube Cancer
  • Ovarian Cancer
  • Primary Peritoneal Cancer
Intervention  ICMJE Drug: carboplatin and paclitaxel
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.
Other Name: carboplatin , paclitaxel and Gemcitabine
Study Arms  ICMJE Experimental: drug effect

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

Intervention: Drug: carboplatin and paclitaxel
Publications * Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status  ICMJE Unknown status
Estimated Enrollment  ICMJE
 (submitted: April 3, 2012)
314
Original Estimated Enrollment  ICMJE Same as current
Estimated Study Completion Date  ICMJE March 2014
Estimated Primary Completion Date March 2014   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

Inclusion Criteria:

  • 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.

Exclusion Criteria:

  • 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.
Sex/Gender  ICMJE
Sexes Eligible for Study: Female
Ages  ICMJE 18 Years to 70 Years   (Adult, Older Adult)
Accepts Healthy Volunteers  ICMJE No
Contacts  ICMJE Contact information is only displayed when the study is recruiting subjects
Listed Location Countries  ICMJE Korea, Republic of
Removed Location Countries  
 
Administrative Information
NCT Number  ICMJE NCT01570582
Other Study ID Numbers  ICMJE KGOG3017
Has Data Monitoring Committee No
U.S. FDA-regulated Product Not Provided
IPD Sharing Statement  ICMJE Not Provided
Responsible Party Taek Sang Lee, Korean Gynecologic Oncology Group
Study Sponsor  ICMJE Korean Gynecologic Oncology Group
Collaborators  ICMJE Not Provided
Investigators  ICMJE Not Provided
PRS Account Korean Gynecologic Oncology Group
Verification Date April 2012

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP