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Adjuvant Treatment for Incomplete Resection Thymoma or Thymic Carcinoma

NCT ID: NCT02633514

Last Updated: 2023-12-05

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

RECRUITING

Clinical Phase

PHASE3

Total Enrollment

1 participants

Study Classification

INTERVENTIONAL

Study Start Date

2023-12-01

Study Completion Date

2026-12-31

Brief Summary

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This study is designed to investigate whether adjuvant radiochemotherapy after incomplete resection has a better survival than adjuvant radiotherapy for thymoma or thymic carcinoma.

Detailed Description

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The previous trials have showed that radiotherapy was significantly associated with prolonged OS and chemotherapy is playing an increasing role in treatment of patients with thymoma or thymic carcinoma.However,whether patients with thymoma or thymic carcinoma could benefit from adjuvant radiochemotherapy after incomplete resection remains controversial. The purpose of this study is to investigate whether adjuvant radiochemotherapy after incomplete resection can improve survival for thymoma or thymic carcinoma.

Conditions

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Thymoma and Thymic Carcinoma

Keywords

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thymoma thymic carcinoma adjuvant radiotherapy adjuvant radiochemotherapy incomplete resection

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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Radiochemotherapy

adjuvant radiochemotherapy after incomplete resection: Cisplatin + Etoposide + Radiotherapy (60Gy / 30FX)

Group Type EXPERIMENTAL

Cisplatin

Intervention Type DRUG

25mg/m2,iv gtt,d1-3

Etoposide

Intervention Type DRUG

75mg/m2,iv gtt,d1-3

radiotherapy

Intervention Type RADIATION

60Gy/30Fx

radiotherapy

adjuvant radiotherapy after incomplete resection: Radiotherapy (60Gy / 30FX)

Group Type SHAM_COMPARATOR

radiotherapy

Intervention Type RADIATION

60Gy/30Fx

Interventions

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Cisplatin

25mg/m2,iv gtt,d1-3

Intervention Type DRUG

Etoposide

75mg/m2,iv gtt,d1-3

Intervention Type DRUG

radiotherapy

60Gy/30Fx

Intervention Type RADIATION

Other Intervention Names

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DDP VP-16

Eligibility Criteria

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Inclusion Criteria

18\~75 years old; Eastern Cooperative Oncology Group performance status of 0 to 2; Pathologically confirmed ; incomplete resection (R1 or R2);have adequate bone marrow, hepatic, and renal function;Patients receive incomplete resection within 3 months; Written informed consent.

Exclusion Criteria

Patients with distant metastases; Patients underwent radiotherapy or chemotherapy; Patients who have malignancy history excluding carcinoma in situ of cervix in the previous five years; Active clinical pulmonary infection; Pregnant or nursing.
Minimum Eligible Age

18 Years

Maximum Eligible Age

75 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Fudan University

OTHER

Sponsor Role lead

Responsible Party

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Kailiang Wu

professor

Responsibility Role PRINCIPAL_INVESTIGATOR

Principal Investigators

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Kailiang Wu, MD. PhD

Role: PRINCIPAL_INVESTIGATOR

Fudan University

Locations

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Kailiang Wu

Shanghai, Shanghai Municipality, China

Site Status RECRUITING

Countries

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China

Central Contacts

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Kailiang Wu, MD.PhD.

Role: CONTACT

Phone: +86 64175590

Email: [email protected]

Xingwen Fan, MD

Role: CONTACT

Phone: +8613651669687

Email: [email protected]

Facility Contacts

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Kailiang Wu, M.D. Ph. D.

Role: primary

Other Identifiers

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1508151-6

Identifier Type: -

Identifier Source: org_study_id