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

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ClinicalTrials.gov Identifier: NCT04731610
Recruitment Status : Not yet recruiting
First Posted : February 1, 2021
Last Update Posted : July 2, 2021
Sponsor:
Information provided by (Responsible Party):
Institut Curie

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.

Condition or disease Intervention/treatment Phase
Thymoma Malignant Recurrent Other: Radiotherapy Other: Surveillance after resection Not Applicable

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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 314 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: Randomized, Multicenter, Phase III Trial to Assess Conformal Post-operative Radiotherapy vs. Surveillance After Complete Resection of Stage II/III Thymoma
Estimated Study Start Date : July 2, 2021
Estimated Primary Completion Date : February 1, 2025
Estimated Study Completion Date : March 1, 2029

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Thymus Cancer

Arm Intervention/treatment
Post-operative radiotherapy
Tumour resection followed by radiotherapy.
Other: Radiotherapy
postoperative radiotherapy after complete resection of thymoma

Surveillance after tumour resection
Tumour resection
Other: Surveillance after resection
Surveillance after tumour resection




Primary Outcome Measures :
  1. Recurrence-Free survival (RFS) [ Time Frame: 3 years ]
    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.


Secondary Outcome Measures :
  1. Local-regional (pleural or pericardial) recurrence [ Time Frame: 3 years ]
    Local-regional (pleural or pericardial) recurrence; location of recurrence /removed



Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years to 75 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
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


Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT04731610


Contacts
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Contact: Francis NYASSE (0) 1.47.11.18. 91 ext 33 gilles.nyassemessene@curie.fr

Locations
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Sponsors and Collaborators
Institut Curie
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Responsible Party: Institut Curie
ClinicalTrials.gov Identifier: NCT04731610    
Other Study ID Numbers: IC 2020-09
First Posted: February 1, 2021    Key Record Dates
Last Update Posted: July 2, 2021
Last Verified: July 2021
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Additional relevant MeSH terms:
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Thymoma
Thymus Neoplasms
Neoplasms, Complex and Mixed
Neoplasms by Histologic Type
Neoplasms
Thoracic Neoplasms
Neoplasms by Site
Lymphatic Diseases