Chemoradiotherapy for Limited Advanced Unresectable Thymic Epithelial Tumors

February 5, 2020 updated by: Kailiang Wu, Fudan University

Phase Ⅱ Study of Concurrent Chemoradiotherapy for Limited Advanced Unresectable Thymic Epithelial Tumors

This study is designed to evaluate the feasibility and safety of concurrent chemoradiotherapy for limited advanced unresectable thymoma or thymic carcinoma.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Detailed Description

Complete resection is difficult to achieve without damaging the main organs in advanced thymoma or thymic carcinoma. The previous trials have showed that radiotherapy was significantly associated with prolonged OS and chemotherapy is playing an increasing role in treatment of patients with advanced thymoma or thymic carcinoma. However, whether concurrent chemoradiotherapy is safety in advanced thymoma or thymic carcinoma is still unknown. The purpose of this study is to evaluate the feasibility and safety of concurrent chemoradiotherapy for limited advanced unresectable thymoma or thymic carcinoma.

Study Type

Interventional

Enrollment (Actual)

56

Phase

  • Not Applicable

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

  • China
    • Shanghai
      • Shanghai, Shanghai, China, 20032
        • Kailiang Wu

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

16 years to 73 years (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

Inclusion Criteria:

1.18~75 years old; 2.Eastern Cooperative Oncology Group performance status of 0 to 2; 3.Pathologically or cytologically confirmed untreated thymoma or thymic carcinoma; 4.Unresectable, limited adanced disease could be encompassed within a tolerable radiotherapy field; 5.Have adequate bone marrow, hepatic, and renal function; 6.Patients who cannot receive surgery resection; 7.Written informed consent.

Exclusion Criteria:

  1. Distant metastases could not be encompassed within a tolerable radiotherapy field;
  2. Underwent surgery, radiotherapy or chemotherapy before entering this study ;
  3. Have other malignancy history excluding carcinoma in situ of cervix in the previous five years;
  4. Active clinical pulmonary infection;
  5. Pregnant or nursing.

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: chemoradiation
concurrent chemoradiation.
Radiation: concurrent chemoradiation
The patients receive chemotherapy concurrent with Radiotherapy. The prescription dose is 60Gy in 30 fractions in 6 weeks.The chemotherapy regimen is cisplatin (25mg/m2,iv drip,d1-3) and etoposide (75mg/m2,iv drip,d1-3),q4w*4.

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Objective response rate
Time Frame: 3 months after treatment
Evaluated using RECIST (Response Evaluation Criteria in Solid Tumors) 1.0 criteria
3 months after treatment

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Overall survival
Time Frame: 2 years
from registration to death as a result of any cause.
2 years
Progression free survival
Time Frame: 2 years
from registration to first documentation of disease progression or death.
2 years
Number of Participants with Treatment Related Adverse Events as Assessed by CTCAE v4.0
Time Frame: up to 2 years
Number of Participants with Treatment Related Adverse Events as Assessed by CTCAE v4.0
up to 2 years

Collaborators and Investigators

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

Sponsor

Fudan University

Investigators

  • Principal Investigator: Kailiang Wu, M.D.,Ph.D, Fudan University

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 (Actual)

June 1, 2011

Primary Completion (Actual)

August 1, 2018

Study Completion (Actual)

February 1, 2020

Study Registration Dates

First Submitted

December 15, 2015

First Submitted That Met QC Criteria

December 18, 2015

First Posted (Estimate)

December 21, 2015

Study Record Updates

Last Update Posted (Actual)

February 7, 2020

Last Update Submitted That Met QC Criteria

February 5, 2020

Last Verified

February 1, 2020

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 1508151-5

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

No

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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