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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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Post-operative radiotherapy | Other | Tumour resection followed by radiotherapy. |
|
| Surveillance after tumour resection | Other | Tumour resection |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Radiotherapy | Other | postoperative radiotherapy after complete resection of thymoma |
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| Measure | Description | Time Frame |
|---|---|---|
| Recurrence-Free survival (RFS) | 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. | 3 years |
| Measure | Description | Time Frame |
|---|---|---|
| Local-regional (pleural or pericardial) recurrence | Local-regional (pleural or pericardial) recurrence; location of recurrence /removed | 3 years |
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Inclusion Criteria:
Exclusion Criteria:
- 1. Age > 75 years old 2. Histology of thymic carcinoma 3. Delivery of post-operative chemotherapy, concurrent chemotherapy to radiotherapy 4. Presence of microscopic or macroscopic residual tumor after surgery or metastases (R1 or R2 resection) 5. Uncontrolled, clinically significant pleural or pericardial effusion 6. 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 7. Evidence of severe or uncontrolled systemic disease as judged by the investigator 8. 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 10. Pregnancy or breast feeding or inadequate contraceptive measures for women of childbearing potential during PORT 11. Patients who, for family, social, geographic or psychological reasons, cannot be adequately followed up and/or are incapable of undergoing regular controls, 12. Patients deprived of freedom or under guardianship
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| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Nicolas GIRARD, PR | Contact | (0)1 44 32 46 06 | +33 | nicolas.girard2@curie.fr |
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| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| CHU Caen | Recruiting | Caen | 14000 | France |
Sponsor will share de-identified data sets . Documents generated under the project will be disseminated in accordance with Institut Curie policies.
Data requests can be submitted starting 9 months after last article publication and will be made accessible for up to 12 months.
Access to trial individual participant data can be requested by qualified researchers engaging in independent scientific research, and will be provided following review and approval of a research proposal and Statistical Analysis Plan (SAP) and execution of a data sharing agreement (DSA).
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| Surveillance after resection | Other | Surveillance after tumour resection |
|
| CLCC François BACLESSE | Recruiting | Caen | 14000 | France |
|
| CLCC Georges François Leclerc | Recruiting | Dijon | 21079 | France |
|
| Centre Oscar Lambret | Recruiting | Lille | 59000 | France |
|
| CHU Lyon | Recruiting | Lyon | 69002 | France |
|
| AP-HM Hôpital Nord | Recruiting | Marseille | 13005 | France |
|
| Institut du Cancer de Montpellier | Not yet recruiting | Montpellier | 34090 | France |
|
| Antoine LACASSAGNE | Not yet recruiting | Nice | 06189 | France |
|
| Institut Curie | Recruiting | Paris | 75005 | France |
|
| Hôpital Européen Georges Pompidou | Not yet recruiting | Paris | 75015 | France |
|
| Hôpital Bichat AP-HP | Recruiting | Paris | 75018 | France |
|
| CHU Haut Lévêque | Not yet recruiting | Pessac | 33604 Cedex | France |
|
| CHU Rennes Hôpital Sud | Recruiting | Rennes | 35056 | France |
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| CHU Rouen | Withdrawn | Rouen | France |
| CLCC Henri Becquerel | Not yet recruiting | Rouen | France |
|
| Institut de Cancérologie de l'Ouest | Recruiting | Saint-Herblain | 44805 | France |
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| CHU Strasbourg | Not yet recruiting | Strasbourg | 67098 | France |
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| Institut Claudius Regaud | Recruiting | Toulouse | 31300 | France |
|
| CHRU Tours | Recruiting | Tours | 37044 | France |
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| Institut de Cancérologie de Lorraine Nancy | Recruiting | Vandœuvre-lès-Nancy | 54519 | France |
|
| Gustave Roussy | Recruiting | Villejuif | 94800 | France |
|
| ID | Term |
|---|---|
| D011878 | Radiotherapy |
| ID | Term |
|---|---|
| D013812 | Therapeutics |
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