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临床试验/NCT02633514
NCT02633514
撤回
3 期

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

Fudan University2 个研究点 分布在 1 个国家目标入组 1 人2023年12月1日

概览

阶段
3 期
干预措施
radiotherapy
疾病 / 适应症
Thymoma and Thymic Carcinoma
发起方
Fudan University
入组人数
1
试验地点
2
主要终点
Progression free survival
状态
撤回
最后更新
5天前

概览

简要总结

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

详细描述

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.

注册库
clinicaltrials.gov
开始日期
2023年12月1日
结束日期
2026年12月1日
最后更新
5天前
研究类型
Interventional
研究设计
Parallel
性别
All

研究者

责任方
Principal Investigator
主要研究者

Kailiang Wu

professor

Fudan University

入排标准

入选标准

  • 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.

排除标准

  • 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.

研究组 & 干预措施

Radiochemotherapy

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

干预措施: radiotherapy

radiotherapy

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

干预措施: radiotherapy

Radiochemotherapy

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

干预措施: Cisplatin

Radiochemotherapy

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

干预措施: Etoposide

结局指标

主要结局

Progression free survival

时间窗: 2 years

from registration to disease progression or death.

次要结局

  • Overall survival(2 years)
  • Number of Participants with Treatment- Related Adverse Events as Assessed by CTCAE v4.0(2 years)

研究点 (2)

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