Neoadjuvant Chemotherapy for Locally Advanced Thymic Cancer

This study is currently recruiting participants. (see Contacts and Locations)
Verified May 2013 by Samsung Medical Center
Information provided by (Responsible Party):
Keunchil Park, Samsung Medical Center Identifier:
First received: March 6, 2011
Last updated: May 29, 2013
Last verified: May 2013

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

Condition Intervention Phase
Locally Advanced Stage III or IV Thymic Cancer
Drug: neoadjuvant docetaxel/cisplatin
Phase 2

Study Type: Interventional
Study Design: Intervention Model: Single Group Assignment
Masking: Open Label
Primary Purpose: Treatment
Official Title: A Prospective, Phase II Trial of Induction Chemotherapy With Docetaxel/Cisplatin for Masaoka Stage III/IV Thymic Epithelial Tumors

Resource links provided by NLM:

Further study details as provided by Samsung Medical Center:

Primary Outcome Measures:
  • Complete resection rate [ Time Frame: 4-8 weeks later after completion of neoadjuvant chemotherapy ] [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • the number of patients with adverse events [ Time Frame: from enrollment to 6 months after completion of chemotherapy ] [ Designated as safety issue: Yes ]

Estimated Enrollment: 27
Study Start Date: February 2007
Estimated Study Completion Date: March 2016
Estimated Primary Completion Date: July 2015 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: neoadjuvant chemotherapy
3 cycles of docetaxel/cisplatin before operation
Drug: neoadjuvant docetaxel/cisplatin
3 cycles of docetaxel plus cisplatin docetaxel 75mg/m2 D1 cisplatin 75mg/m2 D1 every 3 weeks


Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No

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.
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its identifier: NCT01312324

Contact: Keunchil Park, Pf 82-2-3410-3459

Korea, Republic of
Samsung Medical Center Recruiting
Seoul, Korea, Republic of, 135-710
Contact: keunchil Park, pf    822-3410-3459   
Sponsors and Collaborators
Samsung Medical Center
  More Information

No publications provided

Responsible Party: Keunchil Park, Principal investigator, Samsung Medical Center Identifier: NCT01312324     History of Changes
Other Study ID Numbers: 2007-01-040
Study First Received: March 6, 2011
Last Updated: May 29, 2013
Health Authority: South Korea: Korean Food and Drug Administration

Keywords provided by Samsung Medical Center:
neoadjuvant chemotherapy
thymic cancer

Additional relevant MeSH terms:
Antimitotic Agents
Antineoplastic Agents
Mitosis Modulators
Molecular Mechanisms of Pharmacological Action
Pharmacologic Actions
Therapeutic Uses
Tubulin Modulators processed this record on March 30, 2015