Neoadjuvant Chemotherapy for Locally Advanced Thymic Cancer

This study is currently recruiting participants.
Verified May 2013 by Samsung Medical Center
Sponsor:
Information provided by (Responsible Party):
Keunchil Park, Samsung Medical Center
ClinicalTrials.gov Identifier:
NCT01312324
First received: March 6, 2011
Last updated: May 29, 2013
Last verified: May 2013
  Purpose

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

  Eligibility

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

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
Please refer to this study by its ClinicalTrials.gov identifier: NCT01312324

Contacts
Contact: Keunchil Park, Pf 82-2-3410-3459 kpark@skku.edu

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

No publications provided

Responsible Party: Keunchil Park, Principal investigator, Samsung Medical Center
ClinicalTrials.gov 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:
Thymus Neoplasms
Thoracic Neoplasms
Neoplasms by Site
Neoplasms
Lymphatic Diseases
Docetaxel
Cisplatin
Antineoplastic Agents
Therapeutic Uses
Pharmacologic Actions
Radiation-Sensitizing Agents
Physiological Effects of Drugs

ClinicalTrials.gov processed this record on April 14, 2014