RecruitingPhase 3NCT02633514

Adjuvant Treatment for Incomplete Resection Thymoma or Thymic Carcinoma

A Randomized Phase III Study of Adjuvant Radiotherapy Versus Adjuvant Radiochemotherapy in Patients With Incomplete ResectionThymoma or Thymic Carcinoma


Sponsor

Fudan University

Enrollment

1 participants

Start Date

Dec 1, 2023

Study Type

INTERVENTIONAL

Conditions

Summary

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


Eligibility

Min Age: 18 YearsMax Age: 75 Years

Inclusion Criteria1

  • \~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 Criteria1

  • 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.

Interventions

DRUGCisplatin

25mg/m2,iv gtt,d1-3

DRUGEtoposide

75mg/m2,iv gtt,d1-3

RADIATIONradiotherapy

60Gy/30Fx


Locations(1)

Kailiang Wu

Shanghai, Shanghai Municipality, China

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NCT02633514


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