Clinical trial NCT04731610: Randomized, Multicenter, Phase III Trial to Assess Conformal Post-operative Radiotherapy vs. Surveillance After Complete Resection of Stage II/III Thymoma
Official title: Randomized, Multicenter, Phase III Trial to Assess Conformal Post-operative Radiotherapy vs. Surveillance After Complete Resection of Stage II/III Thymoma
Study type: INTERVENTIONAL
Overall status: RECRUITING
Phase: NA
Conditions: Thymoma Malignant Recurrent
Lead sponsor: Institut Curie
Sponsor class: OTHER
First posted: 2021-02-01
Enrollment: 314
Sex: ALL
Minimum age (years): 18
Maximum age (years): 75
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief 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.


Eligibility criteria: 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) performed before treatment
8. Availability of a thoracic Computed-Tomography (CT) scan with IV contrast 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

Primary outcomes:
measure: Recurrence-Free survival (RFS)
timeFrame: 3 years
Secondary outcomes:
measure: Local-regional (pleural or pericardial) recurrence
timeFrame: 3 years
Other outcomes:
Locations:
city: Caen
country: France
facility: CHU Caen
city: Caen
country: France
facility: CLCC François BACLESSE
city: Dijon
country: France
facility: CLCC Georges François Leclerc
city: Lille
country: France
facility: Centre Oscar Lambret
city: Lyon
country: France
facility: CHU Lyon
city: Marseille
country: France
facility: AP-HM Hôpital Nord
city: Montpellier
country: France
facility: Institut du Cancer de Montpellier
city: Paris
country: France
facility: Institut Curie
city: Paris
country: France
facility: Hôpital Européen Georges Pompidou
city: Paris
country: France
facility: Hôpital Bichat AP-HP
city: Pessac
country: France
facility: CHU Haut Lévêque
city: Rennes
country: France
facility: CHU Rennes Hôpital Sud
city: Rouen
country: France
facility: CHU Rouen
city: Rouen
country: France
facility: CLCC Henri Becquerel
city: Saint-Herblain
country: France
facility: Institut de Cancérologie de l'Ouest
city: Strasbourg
country: France
facility: CHU Strasbourg
city: Toulouse
country: France
facility: Institut Claudius Regaud
city: Tours
country: France
facility: CHRU Tours
city: Vandœuvre-lès-Nancy
country: France
facility: Institut de Cancérologie de Lorraine Nancy
city: Villejuif
country: France
facility: Gustave Roussy
Study officials:
References: