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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

  1. How often do I need to come in, and for how long each time?
  2. Are travel costs paid?
  3. Can I keep my own doctor?
  4. What happens if I want to stop?

Contact the study team: see the registry record → Contacts and Locations

Print a page for my doctor

Data 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