Postoperative Conformal Radiotherapy for Stage II-III B Type Thymoma

July 14, 2020 updated by: Ye Zhang, Cancer Institute and Hospital, Chinese Academy of Medical Sciences

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

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.

Study Overview

Status

Unknown

Conditions

Intervention / Treatment

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 Type

Interventional

Enrollment (Anticipated)

210

Phase

  • Phase 3

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • China
      • Beijing, China, 100021
        • Recruiting
        • Cancer hospital, Chineses Academy of Medical Sciences
        • Contact:
        • Principal Investigator:
          • Qinfu Feng, M.D.

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years to 75 years (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

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.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / 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

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
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
3 year after the end of all enrollment

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
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
3 year after the end of all enrollment

Other Outcome Measures

Outcome Measure
Measure Description
Time Frame
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
within 3 year after the end of all enrollment
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
within 3 years after all enrollment

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Cancer Institute and Hospital, Chinese Academy of Medical Sciences

Collaborators

Beijing Hospital
309th Hospital of Chinese People's Liberation Army

Investigators

  • Principal Investigator: Qinfu Feng, M.D., Cancer Institute and Hospital, Chinese Academy of Medical Sciences

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

July 1, 2013

Primary Completion (Anticipated)

July 1, 2021

Study Completion (Anticipated)

July 1, 2022

Study Registration Dates

First Submitted

December 7, 2013

First Submitted That Met QC Criteria

December 12, 2013

First Posted (Estimate)

December 18, 2013

Study Record Updates

Last Update Posted (Actual)

July 16, 2020

Last Update Submitted That Met QC Criteria

July 14, 2020

Last Verified

July 1, 2020

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • POCRT

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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