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Efficacy Study of Neoadjuvant Chemotherapy to Treat Advanced Ovarian Cancer

This study has been completed.
Sponsor:
ClinicalTrials.gov Identifier:
NCT01462149
First Posted: October 31, 2011
Last Update Posted: May 31, 2017
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.
Collaborator:
Sanofi
Information provided by (Responsible Party):
Jong-Hyeok Kim, Asan Medical Center
October 25, 2011
October 31, 2011
May 31, 2017
October 2011
June 2016   (Final data collection date for primary outcome measure)
Response rate [ Time Frame: 1 month after completion of study treatment ]
Same as current
Complete list of historical versions of study NCT01462149 on ClinicalTrials.gov Archive Site
  • Number of Participants with Adverse Events as a Measure of Safety and Tolerability [ Time Frame: Before each chemotherapy, an average of 3 week ]
  • Disease-free survival [ Time Frame: 2 years after completion of study treatment ]
  • Overall survival [ Time Frame: 2 years after completion of study treatment ]
  • The number of participants who achieved optimal cytoreduction [ Time Frame: 1 month after completion of study treatment ]
Same as current
Not Provided
Not Provided
 
Efficacy Study of Neoadjuvant Chemotherapy to Treat Advanced Ovarian Cancer
Phase II Trial of Docetaxel and Carboplatin as Neoadjuvant Chemotherapy in Patients With Advanced Ovarian Cancer
Neoadjuvant chemotherapy is alternative treatment option to upfront cytoreductive surgery to treat advanced ovarian cancer. Paclitaxel plus carboplatin is most frequently selected chemotherapeutic regimen for neoadjuvant chemotherapy. Docetaxel had similar therapeutic efficacy compared to paclitaxel in adjuvant chemotherapy trials in ovarian cancer. However, docetaxel had more favorable toxicity profile. Therefore, the investigators aimed to evaluate the efficacy of docetaxel plus carboplatin as neoadjuvant chemotherapy in patients with advanced ovarian cancer.
Not Provided
Interventional
Phase 2
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Advanced Ovarian Cancer
  • Drug: Neoadjuvant chemotherapy
    Docetaxel 75mg/m2BAS, q 3 weeks, 3 cycles
  • Drug: Carboplatin
    Carboplatin AUC 5, q 3 weeks, 3 cycles
Experimental: Chemotherapy
Neoadjuvant chemotherapy with docetaxel plus carboplatin
Interventions:
  • Drug: Neoadjuvant chemotherapy
  • Drug: Carboplatin
Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Completed
43
June 2016
June 2016   (Final data collection date for primary outcome measure)

Inclusion Criteria:

  • Advanced epithelial, tubal, or primary peritoneal cancer
  • Cancer cells in paracentesis, thoracentesis, or laparoscopic surgery
  • Less probability of complete cytoreduction
  • Age: 20-80 years
  • GOG performance status: 0-3
  • Adequate organ function Bone marrow: ANC ≥ 1,500mm3, Platelet ≥ 100,000/mm3, Hb ≥ 10.0 g/dl Kidney: Creatinine ≤ 1.25 × UNL Liver: AST, ALT ≤ × 2.5 UNL (in case of liver metastasis, AST, ALT ≤ × 5 UNL), alkaline phosphatase ≤ 5 x UNL, bilirubin ≤ 1.5 mg/ mm3

Exclusion Criteria:

  • Previous chemotherapy or pelvic radiation therapy
  • Final diagnosis is other malignancies
  • Coincidental Other malignancies within 5 years except carcinoma in situ of uterine cervix
  • History of severe allergy
  • Pregnancy, lactating woman
  • Uncontrolled medial disease
  • Bowel obstruction requiring immediate surgery
  • Etc.
Sexes Eligible for Study: Female
20 Years to 80 Years   (Adult, Senior)
No
Contact information is only displayed when the study is recruiting subjects
Korea, Republic of
 
 
NCT01462149
NEODOCA-OVCA
No
Not Provided
Not Provided
Jong-Hyeok Kim, Asan Medical Center
Asan Medical Center
Sanofi
Not Provided
Asan Medical Center
May 2017

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