Postoperative Conformal Radiotherapy for Stage II-III B Type Thymoma

This study is currently recruiting participants. (see Contacts and Locations)
Verified December 2013 by Chinese Academy of Medical Sciences
Sponsor:
Collaborators:
Beijing Hospital
The 309 Hospital of People's Liberation Army
Information provided by (Responsible Party):
Ye Zhang, Chinese Academy of Medical Sciences
ClinicalTrials.gov Identifier:
NCT02014805
First received: December 7, 2013
Last updated: December 12, 2013
Last verified: December 2013
  Purpose

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 Intervention Phase
Thymoma
Radiation: radiotherapy
Phase 3

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Parallel Assignment
Masking: Open Label
Primary Purpose: Treatment
Official Title: A Multi-institutional, Randomized Controlled Trial of Postoperative Conformal Radiotherapy for Stage II-III B Type Thymoma

Resource links provided by NLM:


Further study details as provided by Chinese Academy of Medical Sciences:

Primary Outcome Measures:
  • 3 year local control rate [ Time Frame: 3 year after the end of all enrollment ] [ Designated as safety issue: No ]
    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 [ Time Frame: 3 year after the end of all enrollment ] [ Designated as safety issue: No ]
    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:
  • toxicity [ Time Frame: within 3 year after the end of all enrollment ] [ Designated as safety issue: Yes ]
    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

  • quality of life [ Time Frame: within 3 years after all enrollment ] [ Designated as safety issue: Yes ]
    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


Estimated Enrollment: 210
Study Start Date: July 2013
Estimated Study Completion Date: July 2021
Estimated Primary Completion Date: July 2018 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
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

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.

  Eligibility

Ages Eligible for Study:   18 Years to 75 Years
Genders Eligible for Study:   Both
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
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT02014805

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

Locations
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
The 309 Hospital of People's Liberation Army
Investigators
Principal Investigator: Qinfu Feng, M.D. Cancer hospital, Chinese Academy of Medical Sciences
  More Information

No publications provided

Responsible Party: Ye Zhang, Attending physician, Chinese Academy of Medical Sciences
ClinicalTrials.gov Identifier: NCT02014805     History of Changes
Other Study ID Numbers: POCRT
Study First Received: December 7, 2013
Last Updated: December 12, 2013
Health Authority: China: Ministry of Health

Keywords provided by Chinese Academy of Medical Sciences:
postoperative
conformal
radiotherapy
thymoma

Additional relevant MeSH terms:
Thymoma
Thymus Neoplasms
Neoplasms, Complex and Mixed
Neoplasms by Histologic Type
Neoplasms
Thoracic Neoplasms
Neoplasms by Site
Lymphatic Diseases

ClinicalTrials.gov processed this record on September 18, 2014