Postoperative Conformal Radiotherapy for Stage II-III B Type Thymoma
Study Details
Study Description
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.
| Condition or Disease | Intervention/Treatment | Phase |
|---|---|---|
|
Phase 3 |
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.
Study Design
Arms and Interventions
| Arm | Intervention/Treatment |
|---|---|
| Experimental: radiotherapy postoperative conformal radiotherapy for Masaoka stage II-III B type thymoma |
Radiation: radiotherapy
postoperative conformal radiotherapy for Masaoka stage II-III B type thymoma
|
| No Intervention: observation no treatment after radical resection for thymoma |
Outcome Measures
Primary Outcome Measures
- 3 year local control rate [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 Outcome Measures
- 3 year failure-free and overall survival [3 year after the end of all enrollment]
failure-free survivail: the interval from the surgery and the recurrence within or out the tumor bed overall survival: the interval from the surgery and the death or lost of follow-up
Other Outcome Measures
- rate of acute and late radiation toxicity [within 3 year after the end of all enrollment]
toxicity: including the acute radition-induced lung toxicity and the late lung toxicity at 1, 3, 6, 9, 12, 18, 24, 30 and 36 month after radiation or observation
- quality of life score [within 3 years after all enrollment]
quality of life: FACT-Lung and EORTC QOL C30 before and after radiation, and at 1, 3, 6, 9, 12, 18, 24, 30, 36 months after radiation or observation
Eligibility Criteria
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.
Contacts and Locations
Locations
| Site | City | State | Country | Postal Code | |
|---|---|---|---|---|---|
| 1 | Cancer hospital, Chineses Academy of Medical Sciences | Beijing | China | 100021 |
Sponsors and Collaborators
- Chinese Academy of Medical Sciences
- Beijing Hospital
- 309th Hospital of Chinese People's Liberation Army
Investigators
- Principal Investigator: Qinfu Feng, M.D., Cancer Institute and Hospital, Chinese Academy of Medical Sciences
Study Documents (Full-Text)
None provided.More Information
Publications
None provided.- POCRT