Neoadjuvant Chemotherapy for Locally Advanced Thymic Cancer

Locally Advanced Stage III or IV Thymic Cancer Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT01312324
• Other study ID #: 2007-01-040
• Status: Completed
• Phase: Phase 2
• First received: March 6, 2011
• Last updated: April 19, 2016
• Start date: February 2007
• Est. completion date: March 2016

Study information

• Verified date: April 2016
• Source: Samsung Medical Center
• Contact: n/a
• Is FDA regulated: No
• Health authority: South Korea: Korean Food and Drug Administration
• Study type: Interventional

Clinical Trial Summary

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

Recruitment information / eligibility

• Status: Completed
• Enrollment: 27
• Est. completion date: March 2016
• Est. primary completion date: July 2015
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years and older

Eligibility

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

Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment

Related Conditions & MeSH terms

• Locally Advanced Stage III or IV Thymic Cancer
• Thymus Neoplasms

Intervention

Drug:
• neoadjuvant docetaxel/cisplatin
3 cycles of docetaxel plus cisplatin docetaxel 75mg/m2 D1 cisplatin 75mg/m2 D1 every 3 weeks

Locations

Country	Name	City	State
Korea, Republic of	Samsung Medical Center	Seoul

Sponsors (1)

Lead Sponsor	Collaborator
Samsung Medical Center

Country where clinical trial is conducted

Korea, Republic of, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Complete resection rate		4-8 weeks later after completion of neoadjuvant chemotherapy	No
Secondary	the number of patients with adverse events		from enrollment to 6 months after completion of chemotherapy	Yes