Skip to main content
OpenTrials
Completed

NCT Number: NCT01462149

Efficacy Study of Neoadjuvant Chemotherapy to Treat 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.

Completed

Looking for future studies?

Notify Me

Key information

Conditions

Advanced Ovarian Cancer

Age range

20 year–80 year

Sex eligibility

Female

Study type

Interventional

Phase

Phase 2

Primary location

Asan Medical Center

Seoul, 138-736, South Korea

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

Neoadjuvant chemotherapy

Drug

Docetaxel 75mg/m2BAS, q 3 weeks, 3 cycles

carboplatin

Drug

Carboplatin AUC 5, q 3 weeks, 3 cycles

Primary outcomes

  1. Response rate

    Time frame: 1 month after completion of study treatment

Secondary outcomes

  1. Number of Participants with Adverse Events as a Measure of Safety and Tolerability

    Time frame: Before each chemotherapy, an average of 3 week

  2. Disease-free survival

    Time frame: 2 years after completion of study treatment

  3. Overall survival

    Time frame: 2 years after completion of study treatment

  4. The number of participants who achieved optimal cytoreduction

    Time frame: 1 month after completion of study treatment

Sponsors and collaborators

Lead sponsor

Asan Medical Center

Other

Collaborators

  • Sanofi

Registry information

Official study title

Phase II Trial of Docetaxel and Carboplatin as Neoadjuvant Chemotherapy in Patients With Advanced Ovarian Cancer

Important dates

Study start
2011
Primary completion
2016
Study completion
2016
First posted
Oct 31, 2011
Registry last updated
May 31, 2017

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

Related clinical trials

Published trials that share one or more normalized conditions with this study.