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Efficacy Study of Neoadjuvant Chemotherapy to Treat Advanced Ovarian Cancer

Primary Purpose

Advanced Ovarian Cancer

Status
Completed
Phase
Phase 2
Locations
Korea, Republic of
Study Type
Interventional
Intervention
Neoadjuvant chemotherapy
Carboplatin
Sponsored by
Asan Medical Center
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Advanced Ovarian Cancer

Eligibility Criteria

20 Years - 80 Years (Adult, Older Adult)FemaleDoes not accept healthy volunteers

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.

Sites / Locations

  • Asan Medical Center

Arms of the Study

Arm 1

Arm Type

Experimental

Arm Label

Chemotherapy

Arm Description

Neoadjuvant chemotherapy with docetaxel plus carboplatin

Outcomes

Primary Outcome Measures

Response rate

Secondary Outcome Measures

Number of Participants with Adverse Events as a Measure of Safety and Tolerability
Disease-free survival
Overall survival
The number of participants who achieved optimal cytoreduction

Full Information

First Posted
October 25, 2011
Last Updated
May 27, 2017
Sponsor
Asan Medical Center
Collaborators
Sanofi
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1. Study Identification

Unique Protocol Identification Number
NCT01462149
Brief Title
Efficacy Study of Neoadjuvant Chemotherapy to Treat Advanced Ovarian Cancer
Official Title
Phase II Trial of Docetaxel and Carboplatin as Neoadjuvant Chemotherapy in Patients With Advanced Ovarian Cancer
Study Type
Interventional

2. Study Status

Record Verification Date
May 2017
Overall Recruitment Status
Completed
Study Start Date
October 2011 (undefined)
Primary Completion Date
June 2016 (Actual)
Study Completion Date
June 2016 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Asan Medical Center
Collaborators
Sanofi

4. Oversight

Data Monitoring Committee
No

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Advanced Ovarian Cancer

7. Study Design

Primary Purpose
Treatment
Study Phase
Phase 2
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
N/A
Enrollment
43 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Chemotherapy
Arm Type
Experimental
Arm Description
Neoadjuvant chemotherapy with docetaxel plus carboplatin
Intervention Type
Drug
Intervention Name(s)
Neoadjuvant chemotherapy
Intervention Description
Docetaxel 75mg/m2BAS, q 3 weeks, 3 cycles
Intervention Type
Drug
Intervention Name(s)
Carboplatin
Intervention Description
Carboplatin AUC 5, q 3 weeks, 3 cycles
Primary Outcome Measure Information:
Title
Response rate
Time Frame
1 month after completion of study treatment
Secondary Outcome Measure Information:
Title
Number of Participants with Adverse Events as a Measure of Safety and Tolerability
Time Frame
Before each chemotherapy, an average of 3 week
Title
Disease-free survival
Time Frame
2 years after completion of study treatment
Title
Overall survival
Time Frame
2 years after completion of study treatment
Title
The number of participants who achieved optimal cytoreduction
Time Frame
1 month after completion of study treatment

10. Eligibility

Sex
Female
Minimum Age & Unit of Time
20 Years
Maximum Age & Unit of Time
80 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
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.
Facility Information:
Facility Name
Asan Medical Center
City
Seoul
ZIP/Postal Code
138-736
Country
Korea, Republic of

12. IPD Sharing Statement

Learn more about this trial

Efficacy Study of Neoadjuvant Chemotherapy to Treat Advanced Ovarian Cancer

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