Postoperative Conformal Radiotherapy for Stage II-III B Type Thymoma

Thymoma Clinical Trial

Official title:

A Multi-institutional, Randomized Controlled Trial of Postoperative Conformal Radiotherapy for Stage II-III B Type Thymoma

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT02014805
• Other study ID #: POCRT
• Status: Recruiting
• Phase: Phase 3
• Start date: July 2013
• Est. completion date: July 2022

Study information

• Verified date: July 2020
• Source: Chinese Academy of Medical Sciences
• Contact: Qinfu Feng, M.D.
• Phone: 8610-87788503
• Email: 13811300221[@]163.com
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 210
• Est. completion date: July 2022
• Est. primary completion date: July 2021
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years to 75 Years

Eligibility

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.

Related Conditions & MeSH terms

• Thymoma
• Thymus Neoplasms

Intervention

Radiation:
• radiotherapy
postoperative conformal radiotherapy for Masaoka stage II-III B type thymoma

Locations

Country	Name	City	State
China	Cancer hospital, Chineses Academy of Medical Sciences	Beijing

Sponsors (3)

Lead Sponsor	Collaborator
Chinese Academy of Medical Sciences	309th Hospital of Chinese People's Liberation Army, Beijing Hospital

Country where clinical trial is conducted

China, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Other	rate of acute and late radiation toxicity	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	within 3 year after the end of all enrollment
Other	quality of life score	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	within 3 years after all enrollment
Primary	3 year local control rate	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	3 year after the end of all enrollment
Secondary	3 year failure-free and overall survival	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	3 year after the end of all enrollment