Randomized, Multicenter, Phase III Trial to Assess Conformal Post-operative Radiotherapy vs. Surveillance After Complete Resection of Stage II/III Thymoma

Institut Curie41 个研究点分布在 1 个国家目标入组 314 人2021年12月28日

适应症Thymoma Malignant Recurrent

干预措施Radiotherapy Surveillance after resection

概览

阶段: 不适用
干预措施: Radiotherapy
疾病 / 适应症: Thymoma Malignant Recurrent
发起方: Institut Curie
入组人数: 314
试验地点: 41
主要终点: Recurrence-Free survival (RFS)
状态: 招募中
最后更新: 12天前

概览研究者入排标准研究组 & 干预措施结局指标研究点相似试验

概览

简要总结

The primary objective of the study : to compare the Recurrence-Free survival (RFS) between arms. RFS is defined as time from randomisation to the first recurrence (either local-regional or distant) or death of any cause.

注册库

clinicaltrials.gov

开始日期

2021年12月28日

结束日期

2032年12月28日

最后更新

12天前

研究类型

Interventional

研究设计

Parallel

性别

All

研究者

发起方

Institut Curie

责任方

Sponsor

入排标准

入选标准

•18 \< Age \< 75 years old
•ECOG performance status ≤1
•Preoperative chemotherapy is allowed. Maximum of 4 cycles are authorized. Surgery should be realized ≤ 2 months after the last chemotherapy injection.
•Histologically diagnosed thymoma at pathological examination of surgical specimen after pathological review; for note, centralized, real-time, systematic pathological review is standard through the RYTHMIC network in France
•Complete resection at pathological examination of the surgical specimen after surgery conducted through standard, recommended approach ensuring accurate assessment of resection status
•Stage IIb or III disease according to the Masaoka-Koga staging system; this corresponds to stage pT1a with capsule invasion, until stage pT3 N0 M0 in the 8th TNM staging system TNM UICC/AJCC
•Availability of thoracic Computed-Tomography (CT) scan with IV contrast (in the absence of contra-indications) or PET scan performed before surgery
•Availability of a thoracic Computed-Tomography (CT) scan with IV contrast (in the absence of contra-indications) showing absence of residual disease after surgical resection of the tumor
•Pulmonary function tests after surgery with FEV1 ≥ 1L or ≥ 35% of the theoretical value and DLCO ≥ 40%
•Signature of informed consent form

排除标准

•Age \> 75 years old
•Histology of thymic carcinoma
•Delivery of post-operative chemotherapy, concurrent chemotherapy to radiotherapy
•Presence of microscopic or macroscopic residual tumor after surgery or metastases (R1 or R2 resection)
•Uncontrolled, clinically significant pleural or pericardial effusion
•Patients with prior radiation therapy to the thorax. Patients treated with conformal radiotherapy for prior breast or head and neck neoplasms should be discussed with PI
•Evidence of severe or uncontrolled systemic disease as judged by the investigator
•Recent (\< 6 months) severe cardiac disease (uncontrolled arrhythmia, congestive heart failure, infarction, pace-maker) or pulmonary disease. Controlled and non clinically symptomatic arrhythmia is allowed.
•9\. Current or past history of neoplasm diagnosed within the last 3 years, except: basal cell carcinoma of the skin, in situ carcinoma of the cervix, and bladder in situ. A patient diagnosed for another neoplasm 3 years ago or more, treated and considered as cured may be included in the study if all the other criteria are respected
•Pregnancy or breast feeding or inadequate contraceptive measures for women of childbearing potential during PORT

研究组 & 干预措施

Post-operative radiotherapy

Tumour resection followed by radiotherapy.

干预措施: Radiotherapy

Surveillance after tumour resection

Tumour resection

干预措施: Surveillance after resection

结局指标

主要结局

Recurrence-Free survival (RFS)

时间窗: 3 years

to compare the Recurrence-Free survival (RFS) between arms. RFS is defined as time from randomisation to the first recurrence (either local-regional or distant) or death of any cause.