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

Launched by INSTITUT CURIE · Jan 26, 2021

Keywords

ClinConnect Summary

This clinical trial is investigating how effective a specific type of radiation treatment, called conformal post-operative radiotherapy, is compared to just monitoring patients after they have had surgery for stage II or III thymoma, a type of tumor that develops in the thymus gland. The main goal is to see which approach helps patients live longer without their cancer coming back. Participants in the study will be randomly assigned to one of the two treatment groups.

To be eligible for this trial, participants should be between 18 and 75 years old and should have had a complete surgical removal of their thymoma, confirmed by a pathologist. They should also be in good overall health, with specific requirements for their lung function. During the trial, participants can expect regular check-ups and monitoring to assess their recovery and any signs of cancer recurrence. It’s important to know that this trial excludes individuals over 75, those with certain types of cancer history, or those who have had previous radiation therapy to the chest.

Gender

ALL

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