Efficacy Study of Neoadjuvant Chemotherapy to Treat Advan... | NCT01462149

Studies
Efficacy Study of Neoadjuvant Chemotherapy to Treat Advanced Ovarian Cancer

NCT01462149

Sponsor

Asan Medical Center

Status

Completed

Last Update Posted

May 31, 2017Actual

Enrollment

43Actual

Phase

Phase 2

Conditions

Advanced Ovarian Cancer

Interventions

Neoadjuvant chemotherapy
Carboplatin

Countries

South Korea

Protocol Section

Identification Module Status Module Sponsor/Collaborators Module Oversight Module Description Module Conditions Module Design Module Arms/Interventions Module Outcomes Module Eligibility Module Contacts/Locations Module References Module IPD Sharing Statement Module

Results Section

Participant Flow Module Baseline Characteristics Module Outcome Measures Module Adverse Events Module More Info Module

Annotation Section

Annotation Module

Document Section

Large Document Module

Derived Section

Miscellaneous Info Module Condition Browse Module Intervention Browse Module

Protocol Section

Identification Module

NCT ID

Results Section

No data available

No data is available for this block.

Annotation Section

No data available

No data is available for this block.

Document Section

No data available

No data is available for this block.

Derived Section

Miscellaneous Info Module

Version Holder

Status Module

Record Verification Date

May 2017

Overall Recruitment Status or Expanded Access Status

Completed

Last Known Status

Not provided

Delayed Posting

Not provided

Why Stopped

Not provided

Expanded Access Info

Start Date

Oct 2011

Primary Completion Date

Jun 2016Actual

Completion Date

Jun 2016Actual

First Submitted Date

Oct 25, 2011

First Submission Date that Met QC Criteria

Oct 27, 2011

First Posted Date

Oct 31, 2011Estimated

Results Waived

Not provided

Results First Submitted Date

Not provided

Results First Submitted that Met QC Criteria

Not provided

Results First Posted Date

Not provided

Certification/Extension (aka Delayed Results) First Submitted Date

Not provided

Certification/Extension First Submitted that Passed QC Review

Not provided

Certification/Extension First Posted Date

Not provided

Last Update Submitted Date

May 27, 2017

Last Update Posted Date

May 31, 2017Actual

Name	Class
Sanofi	INDUSTRY

Oversight Module

Has Data Monitoring Committee (DMC)

Is FDA Regulated Drug

Not provided

Is FDA Regulated Device

Not provided

Is Unapproved Device

Not provided

Pediatric Postmarket Surveillance of a Device Product

Not provided

Product Exported from US

Not provided

FDAAA801 Violation

Not provided

Description Module

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 provided

Design Module

Study Type

Interventional

Number of References to an Expanded Access Study

Not provided

Expanded Access Types

Not provided

Patient Registry

Not provided

Target Follow-Up Duration

Not provided

Phases

Phase 2

Interventional Study Design

Allocation

Biospecimen

No data available

No data is available for this block.

Enrollment

43Actual

Arms/Interventions Module

Arm Groups

Label	Type	Description	Intervention Names
Chemotherapy	Experimental	Neoadjuvant chemotherapy with docetaxel plus carboplatin	Drug: Neoadjuvant chemotherapy Drug: Carboplatin

Interventions

Name	Type	Description	Arm Group Labels	Other Names
Neoadjuvant chemotherapy	Drug	Docetaxel 75mg/m2BAS, q 3 weeks, 3 cycles	Chemotherapy

Outcomes Module

Primary Outcomes

Measure	Description	Time Frame
Response rate		1 month after completion of study treatment

Secondary Outcomes

Measure	Description	Time Frame
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

Other Outcomes

Not provided

Eligibility Module

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.

Accepts Healthy Volunteers

Sex

Female

Sex/Gender Based

Not provided

Sex/Gender Description

Not provided

Minimum Age

20 Years

Maximum Age

80 Years

Standard Ages

AdultOlder Adult

Study Population

Not provided

Sampling Method

Not provided

Contacts/Locations Module

Central Contacts

Not provided

Overall Officials

Not provided

Locations

Facility	Status	City	State	ZIP	Country	Contacts
Asan Medical Center		Seoul		138-736	South Korea

Intervention Browse Module

MeSH Terms

ID	Term
D020360	Neoadjuvant Therapy
D016190	Carboplatin

Ancestor Terms

ID	Term
D003131	Combined Modality Therapy
D013812	Therapeutics
D056831	Coordination Complexes
D009930	Organic Chemicals

Browse Leaves

Not provided

Browse Branches

Not provided