A Multi-institutional, Randomized Controlled Trial of Postoperative Conformal Radiotherapy for Stage II-III B Type Thymoma
Overview
- Phase
- Phase 3
- Intervention
- Not specified
- Conditions
- Thymoma
- Sponsor
- Chinese Academy of Medical Sciences
- Enrollment
- 210
- Locations
- 1
- Primary Endpoint
- 3 year local control rate
- Last Updated
- 5 years ago
Overview
Brief Summary
The purpose of this study is to determine whether postoperative conformal radiotherapy are effective in the treatment of Masaoka stage II-III B type thymoma.
Detailed Description
The role of postoperative radiotherapy in thymoma is controversial. Some retrospective studies were for the radiotherapy, but others were against. However, more inherent biases existed in these trials. Resection, Masaoka stage and pathology were widely accepted as the prognostic factors for thymoma. Furthermore, the frequency of local failure after radical resection was still high in Masaoka stage II-III B type thymoma. With the conformal technique appearing, conformal radiotherapy can escalate the dose without increasing the risk of normal tissue toxicities.
Investigators
Ye Zhang
Attending physician
Chinese Academy of Medical Sciences
Eligibility Criteria
Inclusion Criteria
- •Age 18-75, Zubrod-ECOG-WHO 0-2, the interval of surgery to radiotherapy \< 2months, Masaoka stage II-III and WHO B type thymoma
Exclusion Criteria
- •No second primary tumor, no serious comorbidity, no neoadjuvant anticancer treatment, no adjuvant chemotherapy.
Outcomes
Primary Outcomes
3 year local control rate
Time Frame: 3 year after the end of all enrollment
local control: tumor recurrence in the tumor bed 3 year local control rate: number of patients with tumor recurrence in the tumor bed at 3 years
Secondary Outcomes
- 3 year failure-free and overall survival(3 year after the end of all enrollment)