Efficacy Study of Neoadjuvant Chemotherapy to Treat Advanced Ovarian Cancer

Phase 2

Completed

• Conditions: Advanced Ovarian Cancer
• Interventions: Drug: Neoadjuvant chemotherapy; Drug: Carboplatin

• Registration Number: NCT01462149
• Lead Sponsor: Asan Medical Center

Brief Summary

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.

Detailed Description

Not available

Study Timeline

• Study Start: 2011-10
• Study First Submitted: 2011-10-25
• Study First Submitted QC: 2011-10-27
• Study First Posted: 2011-10-31
• Primary Completion: 2016-06
• Study Completion: 2016-06
• Status Verified: 2017-05
• Last Update Submitted: 2017-05-27
• Last Update Posted: 2017-05-31

Recruitment & Eligibility

• Status: COMPLETED
• Sex: Female
• Target Recruitment: 43

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.

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Arm && Interventions

Group	Intervention	Description
Chemotherapy	Neoadjuvant chemotherapy	Neoadjuvant chemotherapy with docetaxel plus carboplatin
Chemotherapy	Carboplatin	Neoadjuvant chemotherapy with docetaxel plus carboplatin

Primary Outcome Measures

Name	Time	Method
Response rate	1 month after completion of study treatment

Secondary Outcome Measures

Name	Time	Method
Number of Participants with Adverse Events as a Measure of Safety and Tolerability	Before each chemotherapy, an average of 3 week
Disease-free survival	2 years after completion of study treatment
Overall survival	2 years after completion of study treatment
The number of participants who achieved optimal cytoreduction	1 month after completion of study treatment

Trial Locations

Locations (1)

Asan Medical Center; 🇰🇷 Seoul, Korea, Republic of