Chemoradiotherapy for Limited Advanced Unresectable Thymic Epithelial Tumors

Sponsor

Fudan University (Other)

Overall Status

Completed

CT.gov ID

NCT02636556

Collaborator

(none)

Enrollment

Location

Arm

104

Actual Duration (Months)

0.5

Patients Per Site Per Month

Study Details

Study Description

Brief Summary

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

Condition or Disease	Intervention/Treatment	Phase
Thymoma and Thymic Carcinoma	Radiation: concurrent chemoradiation	N/A

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 Design

Study Type:

Interventional

Actual Enrollment :

56 participants

Allocation:

N/A

Intervention Model:

Single Group Assignment

Intervention Model Description:

Intensity modulated radiotherapy with VP-16/CisplatinIntensity modulated radiotherapy with VP-16/Cisplatin

Masking:

None (Open Label)

Primary Purpose:

Treatment

Official Title:

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

Actual Study Start Date :

Jun 1, 2011

Actual Primary Completion Date :

Aug 1, 2018

Actual Study Completion Date :

Feb 1, 2020

Arms and Interventions

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.

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.

Outcome Measures

Primary Outcome Measures

Objective response rate [3 months after treatment]
Evaluated using RECIST (Response Evaluation Criteria in Solid Tumors) 1.0 criteria

Secondary Outcome Measures

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

Eligibility Criteria

Criteria

Ages Eligible for Study:

18 Years to 75 Years

Sexes Eligible for Study:

All

Accepts Healthy Volunteers:

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:

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