Informations générales (source: ClinicalTrials.gov)

NCT04731610 En recrutement IDF
Randomized, Multicenter, Phase III Trial to Assess Conformal Post-operative Radiotherapy vs. Surveillance After Complete Resection of Stage II/III Thymoma (RADIO-RYTHMIC)
Interventional
  • Thymome
  • Tumeurs du thymus
N/A
Institut Curie (Voir sur ClinicalTrials)
décembre 2021
mars 2029
29 juin 2024
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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Etablissements

Les établissements d'Île-de-France ayant mis à jour leurs données Origine et niveau de fiabilité des données
CLCC INSTITUT CURIE En recrutement IDF 04/09/2024 13:49:44  Contacter
Les établissements d'Île-de-France dont les données sont issues de ClinicalTrials.gov Origine et niveau de fiabilité des données
AP-HP - Hôpital Bichat Pierre MORDANT, Pr Recrutement non commencé Contact (sur clinicalTrials)
CLCC INSTITUT GUSTAVE ROUSSY Angela BOTTICELLA, MD En recrutement IDF Contact (sur clinicalTrials)
Les établissements sans correspondance certaine dans le répertoire FINESS dont les données sont issues de ClinicalTrials.gov Origine et niveau de fiabilité des données
AP-HM Hôpital Nord - 13005 - Marseille - France Pascal THOMAS, Pr En recrutement Contact (sur clinicalTrials)
Centre Oscar Lambret - 59000 - Lille - France Florence LE TINIER, MD En recrutement Contact (sur clinicalTrials)
CHRU Tours - 37044 - Tours - France Eric PICHON, MD En recrutement Contact (sur clinicalTrials)
CHU Caen - 14000 - Caen - France Simon DESHAYES, MD En recrutement Contact (sur clinicalTrials)
CHU Lyon - 69002 - Lyon - France Thomas PIERRET, MD En recrutement Contact (sur clinicalTrials)
CHU Rennes Hôpital Sud - 35056 - Rennes - France Charles RICORDEL, MD En recrutement Contact (sur clinicalTrials)
CHU Rouen - Rouen - France Annulé Contact (sur clinicalTrials)
CHU Strasbourg - 67098 - Strasbourg - France Pierre-Emmanuel FALCOZ, Pr Recrutement non commencé Contact (sur clinicalTrials)
CLCC François BACLESSE - 14000 - Caen - France Delphine LEROUGE, MD En recrutement Contact (sur clinicalTrials)
CLCC Georges François Leclerc - 21079 - Dijon - France Etienne MARTIN, MD En recrutement Contact (sur clinicalTrials)
CLCC Henri Becquerel - Rouen - France Sébastien THUREAU, MD Recrutement non commencé Contact (sur clinicalTrials)
Institut Claudius Regaud - 31300 - Toulouse - France Jonathan KHALIFA, MD En recrutement Contact (sur clinicalTrials)
Institut de Cancérologie de Lorraine Nancy - 54519 - Vandœuvre-lès-Nancy - France Mathilde CUENIN, MD En recrutement Contact (sur clinicalTrials)
Institut de Cancérologie de l'Ouest - 44805 - Saint-Herblain - France François THILLAYS, MD En recrutement Contact (sur clinicalTrials)
Institut du Cancer de Montpellier - 34090 - Montpellier - France Xavier QUANTIN, Pr Recrutement non commencé Contact (sur clinicalTrials)

Critères

Tous
Inclusion Criteria:

1. 18 < Age < 75 years old

2. ECOG performance status ≤1

3. Preoperative chemotherapy is allowed. Maximum of 4 cycles are authorized. Surgery
should be realized ≤ 2 months after the last chemotherapy injection.

4. 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

5. Complete resection at pathological examination of the surgical specimen after
surgery conducted through standard, recommended approach ensuring accurate
assessment of resection status

6. 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

7. Availability of thoracic Computed-Tomography (CT) scan with IV contrast (in the
absence of contra-indications) performed before treatment

8. Availability of a thoracic Computed-Tomography (CT) scan with IV contrast showing
absence of residual disease after surgical resection of the tumor

9. Pulmonary function tests after surgery with FEV1 > 1L or ≥ 35% of the theoretical
value and DLCO ≥ 40%

10. Signature of informed consent form


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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