Postoperative Conformal Radiotherapy for Stage II-III B Type Thymoma

Phase 3

• Conditions: Thymoma
• Interventions: Radiation: radiotherapy

• Registration Number: NCT02014805
• Lead Sponsor: Chinese Academy of Medical Sciences

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.

Study Timeline

• Study Start: 2013-07
• Study First Submitted: 2013-12-07
• Study First Submitted QC: 2013-12-12
• Study First Posted: 2013-12-18
• Status Verified: 2020-07
• Last Update Submitted: 2020-07-14
• Last Update Posted: 2020-07-16
• Primary Completion: 2021-07
• Study Completion: 2022-07

Recruitment & Eligibility

• Status: UNKNOWN
• Sex: All
• Target Recruitment: 210

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.

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
radiotherapy	radiotherapy	postoperative conformal radiotherapy for Masaoka stage II-III B type thymoma

Primary Outcome Measures

Name	Time	Method
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

Name	Time	Method
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

Trial Locations

Locations (1)

Cancer hospital, Chineses Academy of Medical Sciences; 🇨🇳 Beijing, China