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Neoadjuvant Chemotherapy for Locally Advanced Thymic Cancer

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details. Identifier: NCT01312324
Recruitment Status : Completed
First Posted : March 10, 2011
Last Update Posted : April 20, 2016
Information provided by (Responsible Party):
Keunchil Park, Samsung Medical Center

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

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

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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 27 participants
Allocation: N/A
Intervention Model: Single Group Assignment
Masking: None (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
Study Start Date : February 2007
Actual Primary Completion Date : July 2015
Actual Study Completion Date : March 2016

Resource links provided by the National Library of Medicine

Arm Intervention/treatment
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

Primary Outcome Measures :
  1. Complete resection rate [ Time Frame: 4-8 weeks later after completion of neoadjuvant chemotherapy ]

Secondary Outcome Measures :
  1. the number of patients with adverse events [ Time Frame: from enrollment to 6 months after completion of chemotherapy ]

Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
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.

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its identifier (NCT number): NCT01312324

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Korea, Republic of
Samsung Medical Center
Seoul, Korea, Republic of, 135-710
Sponsors and Collaborators
Samsung Medical Center
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Responsible Party: Keunchil Park, Principal investigator, Samsung Medical Center Identifier: NCT01312324    
Other Study ID Numbers: 2007-01-040
First Posted: March 10, 2011    Key Record Dates
Last Update Posted: April 20, 2016
Last Verified: April 2016
Keywords provided by Keunchil Park, Samsung Medical Center:
neoadjuvant chemotherapy
thymic cancer
Additional relevant MeSH terms:
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Thymus Neoplasms
Thoracic Neoplasms
Neoplasms by Site
Lymphatic Diseases
Antineoplastic Agents
Tubulin Modulators
Antimitotic Agents
Mitosis Modulators
Molecular Mechanisms of Pharmacological Action