Postoperative Conformal Radiotherapy for Stage II-III B Type Thymoma

NCT ID: NCT02014805

Last Updated: 2020-07-16

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

UNKNOWN

Clinical Phase

PHASE3

Total Enrollment

210 participants

Study Classification

INTERVENTIONAL

Study Start Date

2013-07-31

Study Completion Date

2022-07-31

Brief Summary

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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

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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.

Conditions

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Thymoma

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

NONE

Study Groups

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radiotherapy

postoperative conformal radiotherapy for Masaoka stage II-III B type thymoma

Group Type EXPERIMENTAL

radiotherapy

Intervention Type RADIATION

postoperative conformal radiotherapy for Masaoka stage II-III B type thymoma

observation

no treatment after radical resection for thymoma

Group Type NO_INTERVENTION

No interventions assigned to this group

Interventions

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radiotherapy

postoperative conformal radiotherapy for Masaoka stage II-III B type thymoma

Intervention Type RADIATION

Eligibility Criteria

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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.
Minimum Eligible Age

18 Years

Maximum Eligible Age

75 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Beijing Hospital

OTHER_GOV

Sponsor Role collaborator

309th Hospital of Chinese People's Liberation Army

OTHER

Sponsor Role collaborator

Chinese Academy of Medical Sciences

OTHER

Sponsor Role lead

Responsible Party

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Ye Zhang

Attending physician

Responsibility Role PRINCIPAL_INVESTIGATOR

Principal Investigators

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Qinfu Feng, M.D.

Role: PRINCIPAL_INVESTIGATOR

Cancer Institute and Hospital, Chinese Academy of Medical Sciences

Locations

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Cancer hospital, Chineses Academy of Medical Sciences

Beijing, , China

Site Status RECRUITING

Countries

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China

Central Contacts

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Qinfu Feng, M.D.

Role: CONTACT

8610-87788503

Ye Zhang, M.D.

Role: CONTACT

8610-87788504

Facility Contacts

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Shuting Li, Ph.D.

Role: primary

8610-87788495

Other Identifiers

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POCRT

Identifier Type: -

Identifier Source: org_study_id

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