Efficacy Study of Neoadjuvant Chemotherapy to Treat Advanced Ovarian Cancer

NCT ID: NCT01462149

Last Updated: 2017-05-31

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

PHASE2

Total Enrollment

43 participants

Study Classification

INTERVENTIONAL

Study Start Date

2011-10-31

Study Completion Date

2016-06-30

Brief Summary

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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

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Conditions

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Advanced Ovarian Cancer

Study Design

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Allocation Method

NA

Intervention Model

SINGLE_GROUP

Primary Study Purpose

TREATMENT

Blinding Strategy

NONE

Study Groups

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Chemotherapy

Neoadjuvant chemotherapy with docetaxel plus carboplatin

Group Type EXPERIMENTAL

Neoadjuvant chemotherapy

Intervention Type DRUG

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

Carboplatin

Intervention Type DRUG

Carboplatin AUC 5, q 3 weeks, 3 cycles

Interventions

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Neoadjuvant chemotherapy

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

Intervention Type DRUG

Carboplatin

Carboplatin AUC 5, q 3 weeks, 3 cycles

Intervention Type DRUG

Eligibility Criteria

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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.
Minimum Eligible Age

20 Years

Maximum Eligible Age

80 Years

Eligible Sex

FEMALE

Accepts Healthy Volunteers

No

Sponsors

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Sanofi

INDUSTRY

Sponsor Role collaborator

Asan Medical Center

OTHER

Sponsor Role lead

Responsible Party

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Jong-Hyeok Kim

Professor

Responsibility Role PRINCIPAL_INVESTIGATOR

Locations

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Asan Medical Center

Seoul, , South Korea

Site Status

Countries

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South Korea

Other Identifiers

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NEODOCA-OVCA

Identifier Type: -

Identifier Source: org_study_id

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