Radiation after thymoma surgery: does it keep cancer away?
NCT ID NCT04731610
First seen Jun 27, 2026 · Last updated Jun 27, 2026
Summary
This study looks at whether giving radiation therapy after surgery can stop thymoma (a rare chest tumor) from returning in patients with stage II or III disease. About 314 adults aged 18-75 who had the tumor completely removed will be randomly assigned to receive radiation or just be watched. The main goal is to see if radiation improves the time without cancer coming back.
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Study facts
What this study's own registry entry says, in plain language.
- Phase
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Not a phased trial
Phase numbers describe drug development. The registry uses this when they do not apply, as it does for trials of devices, procedures or behaviour changes, and for observational studies.
- Participants
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About 314 people
The number the study aims to enrol. It can still change while the study runs.
- Started
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Dec 2021
- Expected to finish
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Dec 2032
An estimate. End dates often move.
- Lead sponsor
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Other sponsor
The registry's catch-all category, for sponsors it does not file as a company, a government agency, or a research network.
Who can take part
This study's own entry requirements. Only the study team can say for certain whether you qualify.
- Ages
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18 to 75 years
- Sex
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Anyone
- Healthy volunteers
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Not accepted
This study is not open to healthy volunteers. The entry requirements below say who it is open to.
Show the full entry requirements Hide the full entry requirements
Copied word for word from the study's registry entry, so the wording is the study team's rather than ours.
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
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Conditions
The condition(s) this trial relates to.
As listed by the trial registrant
The condition terms exactly as the trial's registrant entered them.
How to take part
Only the study team decides who joins. These are the ways to reach them.
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The places running it
20 sites. The list below names each one and where it is.
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The official record
ClinicalTrials.gov lists the study team's own contact details, including names and phone numbers. We don't republish those.
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A doctor treating you
A doctor who knows your case can contact a study site on your behalf, and can tell you whether this study is worth pursuing at all.
Contacts and locations
Locations
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AP-HM Hôpital Nord
RECRUITINGMarseille, 13005, France
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Antoine LACASSAGNE
NOT_YET_RECRUITINGNice, 06189, France
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CHRU Tours
RECRUITINGTours, 37044, France
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CHU Caen
RECRUITINGCaen, 14000, France
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CHU Haut Lévêque
NOT_YET_RECRUITINGPessac, 33604 Cedex, France
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CHU Lyon
RECRUITINGLyon, 69002, France
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CHU Rennes Hôpital Sud
RECRUITINGRennes, 35056, France
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CHU Rouen
WITHDRAWNRouen, France
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CHU Strasbourg
NOT_YET_RECRUITINGStrasbourg, 67098, France
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CLCC François BACLESSE
RECRUITINGCaen, 14000, France
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CLCC Georges François Leclerc
RECRUITINGDijon, 21079, France
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CLCC Henri Becquerel
NOT_YET_RECRUITINGRouen, France
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Centre Oscar Lambret
RECRUITINGLille, 59000, France
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Gustave Roussy
RECRUITINGVillejuif, 94800, France
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Hôpital Bichat AP-HP
RECRUITINGParis, 75018, France
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Hôpital Européen Georges Pompidou
NOT_YET_RECRUITINGParis, 75015, France
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Institut Claudius Regaud
RECRUITINGToulouse, 31300, France
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Institut Curie
RECRUITINGParis, 75005, France
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Institut de Cancérologie de Lorraine Nancy
RECRUITINGVandœuvre-lès-Nancy, 54519, France
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Institut de Cancérologie de l'Ouest
RECRUITINGSaint-Herblain, 44805, France
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Institut du Cancer de Montpellier
NOT_YET_RECRUITINGMontpellier, 34090, France
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Other studies related to the condition(s) this trial covers.
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