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Recruiting Not applicable NCT04731610

Randomized, Multicenter, Phase III Trial to Assess Conformal Post-operative Radiotherapy vs. Surveillance After Complete Resection of Stage II/III Thymoma (RADIO-RYTHMIC-01)

No applicable phase (e.g. observational)
Conditions: Thymoma Malignant Recurrent

Sponsor: Institut Curie

trial.available_in: БГ
Overview
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.
Who can participate
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) or PET scan performed before surgery 8. 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 9. Pulmonary function tests after surgery with FEV1 ≥ 1L or ≥ 35% of the theoretical value and DLCO ≥ 40% 10. Signature of informed consent form 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
Interventions
Radiotherapy
OTHER
Surveillance after resection
OTHER
Locations 21
France (21)
CHU Caen
Caen
CLCC François BACLESSE
Caen
CLCC Georges François Leclerc
Dijon
Centre Oscar Lambret
Lille
CHU Lyon
Lyon
AP-HM Hôpital Nord
Marseille
Institut du Cancer de Montpellier
Montpellier
NOT_YET_RECRUITING
Antoine LACASSAGNE
Nice
NOT_YET_RECRUITING
Institut Curie
Paris
Nicolas GIRARD, PR
Hôpital Européen Georges Pompidou
Paris
NOT_YET_RECRUITING
Hôpital Bichat AP-HP
Paris
CHU Haut Lévêque
Pessac
NOT_YET_RECRUITING
CHU Rennes Hôpital Sud
Rennes
CHU Rouen
Rouen
WITHDRAWN
CLCC Henri Becquerel
Rouen
NOT_YET_RECRUITING
Institut de Cancérologie de l'Ouest
Saint-Herblain
CHU Strasbourg
Strasbourg
NOT_YET_RECRUITING
Institut Claudius Regaud
Toulouse
CHRU Tours
Tours
Institut de Cancérologie de Lorraine Nancy
Vandœuvre-lès-Nancy
Gustave Roussy
Villejuif
Technical details
Status
Recruiting
Phase
Not applicable
Study type
INTERVENTIONAL
Sex
Male and female
Minimum age
18 Years
Maximum age
75 Years
Healthy volunteers
No
Start date
28.12.2021
Completion date
28.12.2032
Registry ID
NCT04731610
Source
clinicaltrials.gov
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