NCT01462149

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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
43

participants targeted

Target at P25-P50 for phase_2

Timeline
Completed

Started Oct 2011

Longer than P75 for phase_2

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

October 1, 2011

Completed
24 days until next milestone

First Submitted

Initial submission to the registry

October 25, 2011

Completed
6 days until next milestone

First Posted

Study publicly available on registry

October 31, 2011

Completed
4.6 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

June 1, 2016

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

June 1, 2016

Completed
Last Updated

May 31, 2017

Status Verified

May 1, 2017

Enrollment Period

4.7 years

First QC Date

October 25, 2011

Last Update Submit

May 27, 2017

Conditions

Advanced Ovarian Cancer

Outcome Measures

Primary Outcomes (1)

  • Response rate

    1 month after completion of study treatment

Secondary Outcomes (4)

  • 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

Study Arms (1)

Chemotherapy

EXPERIMENTAL

Neoadjuvant chemotherapy with docetaxel plus carboplatin

Drug: Neoadjuvant chemotherapyDrug: Carboplatin

Interventions

Neoadjuvant chemotherapyDRUG

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

Chemotherapy
CarboplatinDRUG

Carboplatin AUC 5, q 3 weeks, 3 cycles

Chemotherapy

Eligibility Criteria

Age20 Years - 80 Years
Sexfemale
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • 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

You may not qualify if:

  • 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.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Asan Medical Center

Seoul, 138-736, South Korea

Location

MeSH Terms

Interventions

Neoadjuvant TherapyCarboplatin

Intervention Hierarchy (Ancestors)

Combined Modality TherapyTherapeuticsCoordination ComplexesOrganic Chemicals

Study Design

Study Type
interventional
Phase
phase 2
Allocation
NA
Masking
NONE
Purpose
TREATMENT
Intervention Model
SINGLE GROUP
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Professor

Study Record Dates

First Submitted

October 25, 2011

First Posted

October 31, 2011

Study Start

October 1, 2011

Primary Completion

June 1, 2016

Study Completion

June 1, 2016

Last Updated

May 31, 2017

Record last verified: 2017-05

Locations

KR(1)