Phase Ⅱ Study of Concurrent Chemoradiotherapy for Limited Advanced Unresectable Thymic Epithelial Tumors
Overview
- Phase
- N/A
- Intervention
- Not specified
- Conditions
- Thymoma and Thymic Carcinoma
- Sponsor
- Fudan University
- Enrollment
- 56
- Locations
- 1
- Primary Endpoint
- Objective response rate
- Status
- Completed
- Last Updated
- 6 years ago
Overview
Brief Summary
This study is designed to evaluate the feasibility and safety of concurrent chemoradiotherapy for limited advanced unresectable thymoma or thymic carcinoma.
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.
Investigators
Kailiang Wu
professor
Fudan University
Eligibility Criteria
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.
Outcomes
Primary Outcomes
Objective response rate
Time Frame: 3 months after treatment
Evaluated using RECIST (Response Evaluation Criteria in Solid Tumors) 1.0 criteria
Secondary Outcomes
- Overall survival(2 years)
- Number of Participants with Treatment Related Adverse Events as Assessed by CTCAE v4.0(up to 2 years)
- Progression free survival(2 years)