Neoadjuvant Chemotherapy for Locally Advanced Thymic Cancer

April 19, 2016 updated by: Keunchil Park, Samsung Medical Center

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

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

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Actual)

27

Phase

  • Phase 2

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

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 Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: N/A
  • Interventional Model: Single Group Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / 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

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Time Frame
Complete resection rate
Time Frame: 4-8 weeks later after completion of neoadjuvant chemotherapy
4-8 weeks later after completion of neoadjuvant chemotherapy

Secondary Outcome Measures

Outcome Measure
Time Frame
the number of patients with adverse events
Time Frame: from enrollment to 6 months after completion of chemotherapy
from enrollment to 6 months after completion of chemotherapy

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Samsung Medical Center

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

February 1, 2007

Primary Completion (Actual)

July 1, 2015

Study Completion (Actual)

March 1, 2016

Study Registration Dates

First Submitted

March 6, 2011

First Submitted That Met QC Criteria

March 8, 2011

First Posted (Estimate)

March 10, 2011

Study Record Updates

Last Update Posted (Estimate)

April 20, 2016

Last Update Submitted That Met QC Criteria

April 19, 2016

Last Verified

April 1, 2016

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 2007-01-040

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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