Radiotherapy or monitoring alone after surgery for thymoma
Compares radiotherapy with surveillance after complete surgery in adults with thymoma.
Key facts
- Who runs it
- Institut Curie
- Where
- France21 sites in 1 countryChoose a country to see its sites
- Trial code
- Registry 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)
- Status
- Recruiting
- People taking part
- 314 people, planned
- Started
- 28 Dec 2021
- Expected to end
- 28 Dec 2032
- Type of study
- Interventional, 2 groups
- Treatments tested
- Radiotherapy
- Surveillance after resection
- Record updated
- 20 April 2026
Who can take part
AI summary
From the trial's eligibility criteria. Machine-read from the registry text on this page, so it can be wrong. The registry text below and the trial team decide who can take part.
The trial is looking for adults whose stage IIb or III thymoma (a tumour of the thymus gland in the chest) was fully removed by surgery. It compares radiotherapy after surgery with check-ups only.
- Age
- Over 18 and under 75 years old.
- Sex
- All sexes can join.
- Disease stage
- Thymoma confirmed by lab review of the removed tumour. Masaoka-Koga stage IIb or III (pT1a with capsule invasion up to pT3 N0 M0). The tumour must be fully removed, with no disease left on a CT scan after surgery. People must be able to do most daily activities (ECOG performance status ≤1).
- Earlier treatment
- Chemotherapy before surgery is allowed, at most 4 cycles. Surgery must be ≤ 2 months after the last chemotherapy. Chemotherapy after surgery, or given with radiotherapy, is not allowed. No prior radiation therapy to the chest.
- Biomarker or test result
- Lung tests after surgery: FEV1 ≥ 1L or ≥ 35% of the expected value, and DLCO ≥ 40%.
Main reasons for not taking part
- Thymic carcinoma, or tumour left behind after surgery or spread (R1 or R2 resection, metastases)
- Uncontrolled fluid around the lungs or heart
- Severe heart or lung disease in the last 6 months, or severe uncontrolled illness
- Another cancer within the last 3 years, except some skin, cervix or bladder in situ cancers
- Pregnancy, breastfeeding, or no reliable birth control during radiotherapy
The registry criteria, word for word
Show all 12 criteriaShow less
Who can take part
- 18 < Age < 75 years old
- ECOG performance status ≤1
- Preoperative chemotherapy is allowed. Maximum of 4 cycles are authorized. Surgery should be realized ≤ 2 months after the last chemotherapy injection
- 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
- Complete resection at pathological examination of the surgical specimen after surgery conducted through standard, recommended approach ensuring accurate assessment of resection status
- 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
- Availability of thoracic Computed-Tomography (CT) scan with IV contrast (in the absence of contra-indications) or PET scan performed before surgery
- 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
- Pulmonary function tests after surgery with FEV1 ≥ 1L or ≥ 35% of the theoretical value and DLCO ≥ 40%
- Signature of informed consent form
Who cannot take part
- 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
- 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
Check if you might fit
Answer for yourself. This is not a decision: only the study team can say whether you can take part.
- Are you between 18 and 75 years old?
This trial has no sites in United States.
It has sites in one country. Choose a country to see its sites.
About the trial
What the trial wants to find out
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.
The 2 groups in the trial
- Post-operative radiotherapyOther group
Tumour resection followed by radiotherapy.
Treatment: Radiotherapy
- Surveillance after tumour resectionOther group
Tumour resection
Treatment: Surveillance after resection
Questions to ask the study team
- How often do I need to come in, and for how long each time?
- Are travel costs paid?
- Can I keep my own doctor?
- What happens if I want to stop?
Contact the study team: see the registry record → Contacts and Locations
Print a page for my doctorData and sources
- Registry record
- Listed on ClinicalTrials.gov.
- Official title
- Randomized, Multicenter, Phase III Trial to Assess Conformal Post-operative Radiotherapy vs. Surveillance After Complete Resection of Stage II/III Thymoma
- Plain-language title
- Radiotherapy or monitoring alone after surgery for thymomaGenerated from the registry record. The registry title is the official one.
- AI summary
- From the trial's eligibility criteria. Read by machine on 15 November 2026.
- Fit questions
- Built from NCT04731610, who can take part
- Record updated
- 20 April 2026