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Clinical Trials/NCT01312324
NCT01312324CompletedPhase 2

A Prospective, Phase II Trial of Induction Chemotherapy With Docetaxel/Cisplatin for Masaoka Stage III/IV Thymic Epithelial Tumors

Samsung Medical Center1 site in 1 country27 target enrollmentStarted: February 2007Last updated:
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Conditions
Interventions

Trial Snapshot

Phase
Phase 2
Status
Completed
Enrollment
27
Locations
1
Primary Endpoint
Complete resection rate
Study OverviewStudy DesignEligibility CriteriaArms & InterventionsOutcomesInvestigatorsSitesRecords & IdentifiersSimilar Trials

Study Overview

Brief Summary

We try to evaluate whether neoadjuvant docetaxel plus cisplatin can increase the complete resection rate in advanced thymic carcinoma.

Study Design

Study Type
Interventional
Allocation
Na
Intervention Model
Single Group
Primary Purpose
Treatment
Masking
None

Eligibility Criteria

Ages
18 Years to — (Adult, Older Adult)
Sex
All
Accepts Healthy Volunteers
No

Inclusion Criteria

  • •histologically confirmed thymic carcinoma
  • •surgically inoperable Masaoka stage III or IV
  • •at least one measurable disease

Exclusion Criteria

  • •previous myocardiac infarct history within 1 year before the enrollment.

Arms & Interventions

neoadjuvant chemotherapy

Experimental

3 cycles of docetaxel/cisplatin before operation

Intervention: neoadjuvant docetaxel/cisplatin (Drug)

Outcomes

Primary Outcomes

Complete resection rate

Time Frame: 4-8 weeks later after completion of neoadjuvant chemotherapy

Secondary Outcomes

  • the number of patients with adverse events(from enrollment to 6 months after completion of chemotherapy)

Investigators

Sponsor Class
Other
Responsible Party
Principal Investigator
Principal Investigator

Keunchil Park

Principal investigator

Samsung Medical Center

Study Sites (1)

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