Postoperative Conformal Radiotherapy for Stage II-III B Type Thymoma
A Multi-institutional, Randomized Controlled Trial of Postoperative Conformal Radiotherapy for Stage II-III B Type Thymoma
1 other identifier
interventional
210
1 country
1
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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P25-P50 for phase_3
Started Jul 2013
Longer than P75 for phase_3
1 active site
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
Study Start
First participant enrolled
July 1, 2013
CompletedFirst Submitted
Initial submission to the registry
December 7, 2013
CompletedFirst Posted
Study publicly available on registry
December 18, 2013
CompletedPrimary Completion
Last participant's last visit for primary outcome
July 1, 2021
CompletedStudy Completion
Last participant's last visit for all outcomes
July 1, 2022
CompletedJuly 16, 2020
July 1, 2020
8 years
December 7, 2013
July 14, 2020
Conditions
Keywords
Outcome Measures
Primary Outcomes (1)
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 Outcomes (1)
3 year failure-free and overall survival
3 year after the end of all enrollment
Other Outcomes (2)
rate of acute and late radiation toxicity
within 3 year after the end of all enrollment
quality of life score
within 3 years after all enrollment
Study Arms (2)
radiotherapy
EXPERIMENTALpostoperative conformal radiotherapy for Masaoka stage II-III B type thymoma
observation
NO INTERVENTIONno treatment after radical resection for thymoma
Interventions
postoperative conformal radiotherapy for Masaoka stage II-III B type thymoma
Eligibility Criteria
You may qualify if:
- Age 18-75, Zubrod-ECOG-WHO 0-2, the interval of surgery to radiotherapy \< 2months, Masaoka stage II-III and WHO B type thymoma
You may not qualify if:
- No second primary tumor, no serious comorbidity, no neoadjuvant anticancer treatment, no adjuvant chemotherapy.
Contact the study team to confirm eligibility.
Sponsors & Collaborators
- Chinese Academy of Medical Scienceslead
- Beijing Hospitalcollaborator
- 309th Hospital of Chinese People's Liberation Armycollaborator
Study Sites (1)
Cancer hospital, Chineses Academy of Medical Sciences
Beijing, 100021, China
MeSH Terms
Conditions
Interventions
Condition Hierarchy (Ancestors)
Intervention Hierarchy (Ancestors)
Study Officials
- PRINCIPAL INVESTIGATOR
Qinfu Feng, M.D.
Cancer Institute and Hospital, Chinese Academy of Medical Sciences
Central Study Contacts
Study Design
- Study Type
- interventional
- Phase
- phase 3
- Allocation
- RANDOMIZED
- Masking
- NONE
- Purpose
- TREATMENT
- Intervention Model
- PARALLEL
- Sponsor Type
- OTHER
- Responsible Party
- PRINCIPAL INVESTIGATOR
- PI Title
- Attending physician
Study Record Dates
First Submitted
December 7, 2013
First Posted
December 18, 2013
Study Start
July 1, 2013
Primary Completion
July 1, 2021
Study Completion
July 1, 2022
Last Updated
July 16, 2020
Record last verified: 2020-07