Phase
Condition
Carcinoma
Treatment
Radiotherapy
Surveillance after resection
Clinical Study ID
Ages 18-75 All Genders
Study Summary
Eligibility Criteria
Inclusion
Inclusion Criteria:
18 < Age < 75 years old
ECOG performance status ≤1
Preoperative chemotherapy is allowed. Maximum of 4 cycles are authorized. Surgeryshould be realized ≤ 2 months after the last chemotherapy injection.
Histologically diagnosed thymoma at pathological examination of surgical specimenafter pathological review; for note, centralized, real-time, systematic pathologicalreview is standard through the RYTHMIC network in France
Complete resection at pathological examination of the surgical specimen aftersurgery conducted through standard, recommended approach ensuring accurateassessment of resection status
Stage IIb or III disease according to the Masaoka-Koga staging system; thiscorresponds to stage pT1a with capsule invasion, until stage pT3 N0 M0 in the 8thTNM staging system TNM UICC/AJCC
Availability of thoracic Computed-Tomography (CT) scan with IV contrast (in theabsence of contra-indications) or PET scan performed before surgery
Availability of a thoracic Computed-Tomography (CT) scan with IV contrast (in theabsence of contra-indications) showing absence of residual disease after surgicalresection of the tumor
Pulmonary function tests after surgery with FEV1 ≥ 1L or ≥ 35% of the theoreticalvalue and DLCO ≥ 40%
Signature of informed consent form
Exclusion
Exclusion Criteria:
- 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.
- 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
Study Design
Connect with a study center
Institut de Cancérologie de l'Ouest Angers
Angers, 44805
FranceSite Not Available
CHU Caen
Caen, 14000
FranceActive - Recruiting
CLCC François BACLESSE
Caen, 14000
FranceActive - Recruiting
CHU Caen
Caen 3029241, 14000
FranceSite Not Available
CLCC François BACLESSE
Caen 3029241, 14000
FranceActive - Recruiting
CLCC Georges François Leclerc
Dijon, 21079
FranceActive - Recruiting
CLCC Georges François Leclerc
Dijon 3021372, 21079
FranceSite Not Available
Centre Oscar Lambret
Lille, 59000
FranceActive - Recruiting
Centre Oscar Lambret
Lille 2998324, 59000
FranceSite Not Available
CHU Lyon
Lyon, 69002
FranceActive - Recruiting
CHU Lyon
Lyon 2996944, 69002
FranceSite Not Available
AP-HM Hôpital Nord
Marseille, 13005
FranceActive - Recruiting
AP-HM Hôpital Nord
Marseille 2995469, 13005
FranceSite Not Available
Institut du Cancer de Montpellier
Montpellier, 34090
FranceSite Not Available
Institut du Cancer de Montpellier
Montpellier 2992166, 34090
FranceSite Not Available
Antoine LACASSAGNE
Nice, 06189
FranceSite Not Available
Hôpital Bichat AP-HP
Paris, 75018
FranceActive - Recruiting
Hôpital Européen Georges Pompidou
Paris, 75015
FranceSite Not Available
Institut Curie
Paris, 75005
FranceActive - Recruiting
Hôpital Bichat AP-HP
Paris 2988507, 75018
FranceActive - Recruiting
Hôpital Européen Georges Pompidou
Paris 2988507, 75015
FranceSite Not Available
Institut Curie
Paris 2988507, 75005
FranceSite Not Available
CHU Haut Lévêque
Pessac, 33604 Cedex
FranceSite Not Available
CHU Haut Lévêque
Pessac 2987805, 33604 Cedex
FranceSite Not Available
CHU Rennes Hôpital Sud
Rennes, 35056
FranceActive - Recruiting
CHU Rennes Hôpital Sud
Rennes 2983990, 35056
FranceSite Not Available
CHU Rouen
Rouen,
FranceSite Not Available
CLCC Henri Becquerel
Rouen,
FranceSite Not Available
CHU Rouen
Rouen 2982652,
FranceSite Not Available
CLCC Henri Becquerel
Rouen 2982652,
FranceSite Not Available
Institut de Cancérologie de l'Ouest
Saint-Herblain, 44805
FranceActive - Recruiting
Institut de Cancérologie de l'Ouest
Saint-Herblain 2979590, 44805
FranceSite Not Available
CHU Strasbourg
Strasbourg, 67098
FranceSite Not Available
CHU Strasbourg
Strasbourg 2973783, 67098
FranceSite Not Available
Institut Claudius Regaud
Toulouse, 31300
FranceActive - Recruiting
Institut Claudius Regaud
Toulouse 2972315, 31300
FranceSite Not Available
CHRU Tours
Tours, 37044
FranceActive - Recruiting
CHRU Tours
Tours 2972191, 37044
FranceSite Not Available
Institut de Cancérologie de Lorraine Nancy
Vandœuvre-lès-Nancy, 54519
FranceActive - Recruiting
Institut de Cancérologie de Lorraine Nancy
Vandœuvre-lès-Nancy 2970797, 54519
FranceSite Not Available
Gustave Roussy
Villejuif, 94800
FranceActive - Recruiting
Gustave Roussy
Villejuif 2968705, 94800
FranceSite Not Available

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