Postoperative Conformal Radiotherapy for Stage II-III B Type Thymoma
Primary Purpose
Thymoma
Status
Unknown status
Phase
Phase 3
Locations
China
Study Type
Interventional
Intervention
radiotherapy
Sponsored by
About this trial
This is an interventional treatment trial for Thymoma focused on measuring postoperative, conformal, radiotherapy, thymoma
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.
Sites / Locations
- Cancer hospital, Chineses Academy of Medical SciencesRecruiting
Arms of the Study
Arm 1
Arm 2
Arm Type
Experimental
No Intervention
Arm Label
radiotherapy
observation
Arm Description
postoperative conformal radiotherapy for Masaoka stage II-III B type thymoma
no treatment after radical resection for thymoma
Outcomes
Primary Outcome Measures
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
Secondary Outcome Measures
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
Full Information
NCT ID
NCT02014805
First Posted
December 7, 2013
Last Updated
July 14, 2020
Sponsor
Chinese Academy of Medical Sciences
Collaborators
Beijing Hospital, 309th Hospital of Chinese People's Liberation Army
1. Study Identification
Unique Protocol Identification Number
NCT02014805
Brief Title
Postoperative Conformal Radiotherapy for Stage II-III B Type Thymoma
Official Title
A Multi-institutional, Randomized Controlled Trial of Postoperative Conformal Radiotherapy for Stage II-III B Type Thymoma
Study Type
Interventional
2. Study Status
Record Verification Date
July 2020
Overall Recruitment Status
Unknown status
Study Start Date
July 2013 (undefined)
Primary Completion Date
July 2021 (Anticipated)
Study Completion Date
July 2022 (Anticipated)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Chinese Academy of Medical Sciences
Collaborators
Beijing Hospital, 309th Hospital of Chinese People's Liberation Army
4. Oversight
Data Monitoring Committee
Yes
5. 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.
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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Thymoma
Keywords
postoperative, conformal, radiotherapy, thymoma
7. Study Design
Primary Purpose
Treatment
Study Phase
Phase 3
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Randomized
Enrollment
210 (Anticipated)
8. Arms, Groups, and Interventions
Arm Title
radiotherapy
Arm Type
Experimental
Arm Description
postoperative conformal radiotherapy for Masaoka stage II-III B type thymoma
Arm Title
observation
Arm Type
No Intervention
Arm Description
no treatment after radical resection for thymoma
Intervention Type
Radiation
Intervention Name(s)
radiotherapy
Intervention Description
postoperative conformal radiotherapy for Masaoka stage II-III B type thymoma
Primary Outcome Measure Information:
Title
3 year local control rate
Description
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
Time Frame
3 year after the end of all enrollment
Secondary Outcome Measure Information:
Title
3 year failure-free and overall survival
Description
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
Time Frame
3 year after the end of all enrollment
Other Pre-specified Outcome Measures:
Title
rate of acute and late radiation toxicity
Description
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
Time Frame
within 3 year after the end of all enrollment
Title
quality of life score
Description
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
Time Frame
within 3 years after all enrollment
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
75 Years
Accepts Healthy Volunteers
No
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.
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Qinfu Feng, M.D.
Phone
8610-87788503
Email
13811300221@163.com
First Name & Middle Initial & Last Name or Official Title & Degree
Ye Zhang, M.D.
Phone
8610-87788504
Email
drzye1983@163.com
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Qinfu Feng, M.D.
Organizational Affiliation
Cancer Institute and Hospital, Chinese Academy of Medical Sciences
Official's Role
Principal Investigator
Facility Information:
Facility Name
Cancer hospital, Chineses Academy of Medical Sciences
City
Beijing
ZIP/Postal Code
100021
Country
China
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Shuting Li, Ph.D.
Phone
8610-87788495
Email
cancergcp@163.com
First Name & Middle Initial & Last Name & Degree
Qinfu Feng, M.D.
12. IPD Sharing Statement
Learn more about this trial
Postoperative Conformal Radiotherapy for Stage II-III B Type Thymoma
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