Back to resultsNeoadjuvant Chemotherapy for Locally Advanced Thymic Cancer
Primary Purpose
Locally Advanced Stage III or IV Thymic Cancer
Status
Completed
Phase
Phase 2
Locations
Korea, Republic of
Study Type
Interventional
Intervention
neoadjuvant docetaxel/cisplatin
Sponsored by
About this trial
This is an interventional treatment trial for Locally Advanced Stage III or IV Thymic Cancer focused on measuring neoadjuvant chemotherapy, thymic cancer
Eligibility Criteria
Inclusion Criteria:
- histologically confirmed thymic carcinoma
- surgically inoperable Masaoka stage III or IV
- ECOG 0-2
- at least one measurable disease
Exclusion Criteria:
- previous myocardiac infarct history within 1 year before the enrollment.
Sites / Locations
- Samsung Medical Center
Arms of the Study
Arm 1
Arm Type
Experimental
Arm Label
neoadjuvant chemotherapy
Arm Description
3 cycles of docetaxel/cisplatin before operation
Outcomes
Primary Outcome Measures
Complete resection rate
Secondary Outcome Measures
the number of patients with adverse events
Full Information
1. Study Identification
Unique Protocol Identification Number
NCT01312324
Brief Title
Neoadjuvant Chemotherapy for Locally Advanced Thymic Cancer
Official Title
A Prospective, Phase II Trial of Induction Chemotherapy With Docetaxel/Cisplatin for Masaoka Stage III/IV Thymic Epithelial Tumors
Study Type
Interventional
2. Study Status
Record Verification Date
April 2016
Overall Recruitment Status
Completed
Study Start Date
February 2007 (undefined)
Primary Completion Date
July 2015 (Actual)
Study Completion Date
March 2016 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Samsung Medical Center
4. Oversight
Data Monitoring Committee
No
5. Study Description
Brief Summary
We try to evaluate whether neoadjuvant docetaxel plus cisplatin can increase the complete resection rate in advanced thymic carcinoma.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Locally Advanced Stage III or IV Thymic Cancer
Keywords
neoadjuvant chemotherapy, thymic 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
27 (Actual)
8. Arms, Groups, and Interventions
Arm Title
neoadjuvant chemotherapy
Arm Type
Experimental
Arm Description
3 cycles of docetaxel/cisplatin before operation
Intervention Type
Drug
Intervention Name(s)
neoadjuvant docetaxel/cisplatin
Intervention Description
3 cycles of docetaxel plus cisplatin docetaxel 75mg/m2 D1 cisplatin 75mg/m2 D1 every 3 weeks
Primary Outcome Measure Information:
Title
Complete resection rate
Time Frame
4-8 weeks later after completion of neoadjuvant chemotherapy
Secondary Outcome Measure Information:
Title
the number of patients with adverse events
Time Frame
from enrollment to 6 months after completion of chemotherapy
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria:
histologically confirmed thymic carcinoma
surgically inoperable Masaoka stage III or IV
ECOG 0-2
at least one measurable disease
Exclusion Criteria:
previous myocardiac infarct history within 1 year before the enrollment.
Facility Information:
Facility Name
Samsung Medical Center
City
Seoul
ZIP/Postal Code
135-710
Country
Korea, Republic of
12. IPD Sharing Statement
Learn more about this trial
Neoadjuvant Chemotherapy for Locally Advanced Thymic Cancer
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