NCT04731610招募中不适用
Randomized, Multicenter, Phase III Trial to Assess Conformal Post-operative Radiotherapy vs. Surveillance After Complete Resection of Stage II/III Thymoma
适应症
干预措施
试验速览
- 阶段
- 不适用
- 状态
- 招募中
- 入组人数
- 314
- 试验地点
- 41
- 主要终点
- Recurrence-Free survival (RFS)
研究概览
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.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Treatment
- 盲法
- None
入排标准
- 年龄范围
- 18 Years 至 75 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
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
- •Patients who, for family, social, geographic or psychological reasons, cannot be adequately followed up and/or are incapable of undergoing regular controls,
- •Patients deprived of freedom or under guardianship
研究组 & 干预措施
Post-operative radiotherapy
Other
Tumour resection followed by radiotherapy.
干预措施: Radiotherapy (Other)
Surveillance after tumour resection
Other
Tumour resection
干预措施: Surveillance after resection (Other)
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.
次要结局
- Local-regional (pleural or pericardial) recurrence(3 years)
研究者
研究点 (41)
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