Comparing radiotherapy and surveillance after thymoma surgery

Is this trial a fit for you?

A plain-English reading of the study's rules. Only the study team can confirm whether you qualify.

What this trial studies

This clinical trial aims to evaluate the effectiveness of conformal post-operative radiotherapy compared to surveillance in patients who have undergone complete resection of stage II/III thymoma. The primary objective is to assess recurrence-free survival (RFS), which measures the time from randomization to the first recurrence of the disease or death from any cause. Participants will be randomly assigned to either receive radiotherapy or be monitored without immediate treatment. The study involves multiple centers and follows a rigorous protocol to ensure accurate assessment of outcomes.

Why it matters

Who can join: the full rules

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

Where it's running

• CHU Caen
  Caen, France Recruiting
• CLCC François BACLESSE
  Caen, France Recruiting
• CLCC Georges François Leclerc
  Dijon, France Recruiting
• Centre Oscar Lambret
  Lille, France Recruiting
• CHU Lyon
  Lyon, France Recruiting
• AP-HM Hôpital Nord
  Marseille, France Recruiting

Study contacts

• Study coordinator: Nicolas GIRARD, PR
• Email: nicolas.girard2@curie.fr
• Phone: (0)1 44 32 46 06

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How to take part

1. Review the eligibility criteria above with your treating physician.
2. Check the official listing on ClinicalTrials.gov for the latest contact details and recruitment status.
3. Contact the study coordinator or principal investigator to ask for pre-screening. Pre-screening is free and never obligates you to enroll.