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Postoperative Conformal Radiotherapy for Stage II-III B Type Thymoma

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ClinicalTrials.gov Identifier: NCT02014805
Recruitment Status : Recruiting
First Posted : December 18, 2013
Last Update Posted : July 16, 2020
Sponsor:
Collaborators:
Beijing Hospital
309th Hospital of Chinese People's Liberation Army
Information provided by (Responsible Party):
Ye Zhang, Chinese Academy of Medical Sciences

Study Description
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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
Thymoma Radiation: radiotherapy 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
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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 210 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: A Multi-institutional, Randomized Controlled Trial of Postoperative Conformal Radiotherapy for Stage II-III B Type Thymoma
Study Start Date : July 2013
Estimated Primary Completion Date : July 2021
Estimated Study Completion Date : July 2022

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Thymus Cancer

Arms and Interventions
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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
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Primary Outcome Measures :
  1. 3 year local control rate [ Time Frame: 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 :
  1. 3 year failure-free and overall survival [ Time Frame: 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:
  1. rate of acute and late radiation toxicity [ Time Frame: 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

  2. quality of life score [ Time Frame: 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
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Ages Eligible for Study:   18 Years to 75 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
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
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Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02014805


Contacts
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Contact: Qinfu Feng, M.D. 8610-87788503 13811300221@163.com
Contact: Ye Zhang, M.D. 8610-87788504 drzye1983@163.com

Locations
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China
Cancer hospital, Chineses Academy of Medical Sciences Recruiting
Beijing, China, 100021
Contact: Shuting Li, Ph.D.    8610-87788495    cancergcp@163.com   
Principal Investigator: Qinfu Feng, M.D.         
Sponsors and Collaborators
Chinese Academy of Medical Sciences
Beijing Hospital
309th Hospital of Chinese People's Liberation Army
Investigators
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Principal Investigator: Qinfu Feng, M.D. Cancer Institute and Hospital, Chinese Academy of Medical Sciences
More Information
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Responsible Party: Ye Zhang, Attending physician, Chinese Academy of Medical Sciences
ClinicalTrials.gov Identifier: NCT02014805    
Other Study ID Numbers: POCRT
First Posted: December 18, 2013    Key Record Dates
Last Update Posted: July 16, 2020
Last Verified: July 2020
Keywords provided by Ye Zhang, Chinese Academy of Medical Sciences:
postoperative
conformal
radiotherapy
thymoma
Additional relevant MeSH terms:
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Thymoma
Thymus Neoplasms
Neoplasms, Complex and Mixed
Neoplasms by Histologic Type
 Neoplasms
Thoracic Neoplasms
Neoplasms by Site
Lymphatic Diseases