Neoadjuvant Chemotherapy for Locally Advanced Thymic Cancer

Phase 2

Completed

• Conditions: Locally Advanced Stage III or IV Thymic Cancer
• Interventions: Drug: neoadjuvant docetaxel/cisplatin

• Registration Number: NCT01312324
• Lead Sponsor: Samsung Medical Center

Brief Summary

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

Detailed Description

Not available

Study Timeline

• Study Start: 2007-02
• Study First Submitted: 2011-03-06
• Study First Submitted QC: 2011-03-08
• Study First Posted: 2011-03-10
• Primary Completion: 2015-07
• Study Completion: 2016-03
• Status Verified: 2016-04
• Last Update Submitted: 2016-04-19
• Last Update Posted: 2016-04-20

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 27

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.

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Arm && Interventions

Group	Intervention	Description
neoadjuvant chemotherapy	neoadjuvant docetaxel/cisplatin	3 cycles of docetaxel/cisplatin before operation

Primary Outcome Measures

Name	Time	Method
Complete resection rate	4-8 weeks later after completion of neoadjuvant chemotherapy

Secondary Outcome Measures

Name	Time	Method
the number of patients with adverse events	from enrollment to 6 months after completion of chemotherapy

Trial Locations

Locations (1)

Samsung Medical Center; 🇰🇷 Seoul, Korea, Republic of