Actively Recruiting
Randomized, Multicenter, Phase III Trial to Assess Conformal Post-operative Radiotherapy vs. Surveillance After Complete Resection of Stage II/III Thymoma (RADIO-RYTHMIC-01)
Led by Institut Curie · Updated on 2026-04-20
314
Participants Needed
21
Research Sites
574 weeks
Total Duration
On this page
AI-Summary
What this Trial Is About
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.
CONDITIONS
Official Title
Randomized, Multicenter, Phase III Trial to Assess Conformal Post-operative Radiotherapy vs. Surveillance After Complete Resection of Stage II/III Thymoma (RADIO-RYTHMIC-01)
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Age between 18 and 75 years old
- ECOG performance status 0 or 1
- Preoperative chemotherapy allowed up to 4 cycles, with surgery done within 2 months after last chemotherapy
- Histologically confirmed thymoma after pathological review
- Complete tumor resection confirmed by pathological examination
- Stage IIb or III thymoma according to Masaoka-Koga or TNM staging systems
- Availability of thoracic CT scan with IV contrast or PET scan before surgery
- Post-surgery thoracic CT scan showing no residual disease
- Post-surgery pulmonary function with FEV1 at least 1L or 35% of predicted, and DLCO at least 40%
- Signed informed consent form
You will not qualify if you...
- Age over 75 years old
- Histology showing thymic carcinoma
- Post-operative or concurrent chemotherapy with radiotherapy
- Presence of residual tumor or metastases after surgery (R1 or R2 resection)
- Uncontrolled or significant pleural or pericardial effusion
- Prior radiation therapy to the thorax (exceptions discussed with investigator)
- Severe or uncontrolled systemic disease judged by investigator
- Severe cardiac or pulmonary disease within last 6 months (except controlled, asymptomatic arrhythmia)
- History of another neoplasm within last 3 years except certain skin or cervical cancers
- Pregnancy, breastfeeding, or inadequate contraception for women of childbearing potential during radiotherapy
- Inability to undergo regular follow-up due to family, social, geographic, or psychological reasons
- Patients deprived of freedom or under guardianship
AI-Screening
AI-Powered Screening
Complete this quick 3-step screening to check your eligibility
Trial Site Locations
Total: 21 locations
1
CHU Caen
Caen, France, 14000
Actively Recruiting
2
CLCC François BACLESSE
Caen, France, 14000
Actively Recruiting
3
CLCC Georges François Leclerc
Dijon, France, 21079
Actively Recruiting
4
Centre Oscar Lambret
Lille, France, 59000
Actively Recruiting
5
CHU Lyon
Lyon, France, 69002
Actively Recruiting
6
AP-HM Hôpital Nord
Marseille, France, 13005
Actively Recruiting
7
Institut du Cancer de Montpellier
Montpellier, France, 34090
Not Yet Recruiting
8
Antoine LACASSAGNE
Nice, France, 06189
Not Yet Recruiting
9
Institut Curie
Paris, France, 75005
Actively Recruiting
10
Hôpital Européen Georges Pompidou
Paris, France, 75015
Not Yet Recruiting
11
Hôpital Bichat AP-HP
Paris, France, 75018
Actively Recruiting
12
CHU Haut Lévêque
Pessac, France, 33604 Cedex
Not Yet Recruiting
13
CHU Rennes Hôpital Sud
Rennes, France, 35056
Actively Recruiting
14
CHU Rouen
Rouen, France
Withdrawn
15
CLCC Henri Becquerel
Rouen, France
Not Yet Recruiting
16
Institut de Cancérologie de l'Ouest
Saint-Herblain, France, 44805
Actively Recruiting
17
CHU Strasbourg
Strasbourg, France, 67098
Not Yet Recruiting
18
Institut Claudius Regaud
Toulouse, France, 31300
Actively Recruiting
19
CHRU Tours
Tours, France, 37044
Actively Recruiting
20
Institut de Cancérologie de Lorraine Nancy
Vandœuvre-lès-Nancy, France, 54519
Actively Recruiting
21
Gustave Roussy
Villejuif, France, 94800
Actively Recruiting
Research Team
N
Nicolas GIRARD, PR
CONTACT
How is the study designed?
Study Type
INTERVENTIONAL
Masking
NONE
Allocation
RANDOMIZED
Model
PARALLEL
Primary Purpose
TREATMENT
Number of Arms
2
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