Neoadjuvant Chemotherapy for Locally Advanced Thymic Cancer

This study has been completed.
Information provided by (Responsible Party):
Keunchil Park, Samsung Medical Center Identifier:
First received: March 6, 2011
Last updated: April 19, 2016
Last verified: April 2016
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 ]

Enrollment: 27
Study Start Date: February 2007
Study Completion Date: March 2016
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.
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Please refer to this study by its identifier: NCT01312324

Korea, Republic of
Samsung Medical Center
Seoul, Korea, Republic of, 135-710
Sponsors and Collaborators
Samsung Medical Center
  More Information

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: April 19, 2016
Health Authority: South Korea: Korean Food and Drug Administration

Keywords provided by Samsung Medical Center:
neoadjuvant chemotherapy
thymic cancer

Additional relevant MeSH terms:
Thymus Neoplasms
Lymphatic Diseases
Neoplasms by Site
Thoracic Neoplasms
Antimitotic Agents
Antineoplastic Agents
Mitosis Modulators
Molecular Mechanisms of Pharmacological Action
Tubulin Modulators processed this record on May 26, 2016