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AzTrials

Thymoma Malignant RecurrentRADIO-RYTHMICNCT04731610

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

A study testing Radiotherapy and Surveillance after resection in people with Thymoma Malignant Recurrent, run by Institut Curie at 21 sites in France.

Recruiting

Looking for participants now. Contact the study team or a site below to ask about taking part.

Sites and contacts
Official record
Search all trials

Trial summary

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. Read more about this study

Who is it for?
Ages 18 to 75 years
Conditions the study is for
Thymoma Malignant Recurrent
What is being tested?
Radiotherapy and Surveillance after resection
Could I receive a placebo?
No, everyone receives an active treatment
How many people
314 participants
Where
21 sitesFrance
Study dates
28 Dec 2021to 28 Dec 2032
Phase
Interventional
Are there results?
Not yet: the study is under way

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 18 to 75 years
  • All sexes
  • No healthy volunteers
  • Adult, Older adult

Who may be able to join

  • 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
Show all 10Show fewer
  • 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 join

  • 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

Trial locations and contacts

21 sites in 1 country. Contact the study team or a site near you to ask about taking part.

Nicolas GIRARD, PR contact

(0)1 44 32 46 06 ext. +33

nicolas.girard2@curie.fr

21 sites in 1 country

France21 sites, 20 recruiting

  • CHU Caen

    Caen, 14000

    Simon DESHAYES, MD

    Simon DESHAYES, MD

    Recruiting

  • CLCC François BACLESSE

    Caen, 14000

    Delphine LEROUGE, MD

    Delphine LEROUGE, MD

    Recruiting

  • CLCC Georges François Leclerc

    Dijon, 21079

    Etienne MARTIN, MD

    Etienne MARTIN, MD

    Recruiting

  • Centre Oscar Lambret

    Lille, 59000

    Florence LE TINIER, MD

    Florence LE TINIER, MD

    Recruiting

  • CHU Lyon

    Lyon, 69002

    Thomas PIERRET, MD

    Thomas PIERRET, MD

    Recruiting

  • AP-HM Hôpital Nord

    Marseille, 13005

    Pascal THOMAS, Pr

    Pascal THOMAS, Pr

    Recruiting

  • Institut du Cancer de Montpellier

    Montpellier, 34090

    Xavier QUANTIN, Pr

    Xavier QUANTIN, Pr

    Not yet recruiting

  • Antoine LACASSAGNE

    Nice, 06189

    Jérôme DOYEN, MD

    Jérôme DOYEN, MD

    Not yet recruiting

  • Institut Curie

    Paris, 75005

    Nicolas GIRARD, PR, nicolas.girard2@curie.fr

    Nicolas GIRARD, PR

    Recruiting

  • Hôpital Européen Georges Pompidou

    Paris, 75015

    Aurélia ALATI, MD

    Aurélia ALATI, MD

    Not yet recruiting

  • Hôpital Bichat AP-HP

    Paris, 75018

    Valérie GOUNANT, Pr

    Valérie GOUNANT, Pr

    Recruiting

  • CHU Haut Lévêque

    Pessac, 33604 Cedex

    POUYPOUDAT, MD

    Claudia POUYPOUDAT, MD

    Not yet recruiting

  • CHU Rennes Hôpital Sud

    Rennes, 35056

    Charles RICORDEL, MD

    Charles RICORDEL, MD

    Recruiting

  • CHU Rouen

    Rouen

    Withdrawn

  • CLCC Henri Becquerel

    Rouen

    Sébastien THUREAU, MD

    Sébastien THUREAU, MD

    Not yet recruiting

  • Institut de Cancérologie de l'Ouest

    Saint-Herblain, 44805

    François THILLAYS, MD

    François THILLAYS, Pr

    Recruiting

  • CHU Strasbourg

    Strasbourg, 67098

    Pierre-Emmanuel FALCOZ, Pr

    Pierre-Emmanuel FALCOZ, Pr

    Not yet recruiting

  • Institut Claudius Regaud

    Toulouse, 31300

    Jonathan KHALIFA, MD

    Jonathan KHALIFA, MD

    Recruiting

  • CHRU Tours

    Tours, 37044

    Eric PICHON, MD

    Eric PICHON, MD

    Recruiting

  • Institut de Cancérologie de Lorraine Nancy

    Vandœuvre-lès-Nancy, 54519

    Mathilde CUENIN, MD

    Mathilde CUENIN, MD

    Recruiting

  • Gustave Roussy

    Villejuif, 94800

    Angela BOTTICELLA, MD

    Angela BOTTICELLA, MD

    Recruiting

Other trials in France

About this study

Official title: Randomized, Multicenter, Phase III Trial to Assess Conformal Post-operative Radiotherapy vs. Surveillance After Complete Resection of Stage II/III Thymoma

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.

Being tested
Radiotherapy, Surveillance after resection

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • RadiotherapyOther

    postoperative radiotherapy after complete resection of thymoma

  • Surveillance after resectionOther

    Surveillance after tumour resection

Study groups in NCT04731610
Study groupRoleWhat they receive
Post-operative radiotherapyOtherTumour resection followed by radiotherapy.
Receives: Other: Radiotherapy
Surveillance after tumour resectionOtherTumour resection
Receives: Other: Surveillance after resection

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. Recurrence-Free survival (RFS)

    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.

    Measured: 3 years

Secondary outcomes (1)

  1. Local-regional (pleural or pericardial) recurrence

    Local-regional (pleural or pericardial) recurrence; location of recurrence /removed

    Measured: 3 years

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted1 Feb 2021
  2. Study start28 Dec 2021
  3. Primary completion28 Dec 2031 (estimated)
  4. Study completion28 Dec 2032 (estimated)

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Interventional
Phase
Phase N/A
Primary purpose
Treatment
Allocation
Randomised
Intervention model
Parallel groups
Masking
None (open label)
Enrolment
314 participants (estimated)
IDs, dates and publications
ClinicalTrials.gov ID
NCT04731610
Sponsor's protocol ID
IC 2020-09
Acronym
RADIO-RYTHMIC
Status last verified
Apr 2026
First submitted
26 Jan 2021
Last updated
20 Apr 2026
Results posted
No
Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
No
Individual data sharing
Yes: Sponsor will share de-identified data sets . Documents generated under the project will be disseminated in accordance with Institut Curie policies.

Questions about this trial

What is this clinical trial studying?

A study testing Radiotherapy and Surveillance after resection in people with Thymoma Malignant Recurrent, run by Institut Curie at 21 sites in France.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 10 inclusion and 2 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: looking for participants now, as of the sponsor's last update on 20 Apr 2026. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 21 sites in France. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

Are results available for this study?

This study is still under way. Results are not available in the source record yet.

How can a doctor refer a patient or contact the research team?

Contact Nicolas GIRARD, PR ((0)1 44 32 46 06 ext. +33, nicolas.girard2@curie.fr), or a site near the patient. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Recurrence-Free survival (RFS) (time frame: 3 years). It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT04731610.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 20 Apr 2026.

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