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

• Sponsor: Institut Curie (Other)
• Overall Status: Recruiting
• CT.gov ID: NCT04731610
• Collaborator: (none)
• Enrollment: 314
• Locations: 18
• Arms: 2
• Anticipated Duration (Months): 86.1
• Patients Per Site: 17.4
• Patients Per Site Per Month: 0.2

Study Details

Study Description

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	N/A

Study Design

• Study Type: Interventional
• Anticipated 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
• Actual Study Start Date: Dec 28, 2021
• Anticipated Primary Completion Date: Feb 1, 2025
• Anticipated Study Completion Date: Mar 1, 2029

Arms and Interventions

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

Outcome Measures

Primary Outcome Measures

1. Recurrence-Free survival (RFS) [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 [3 years]

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

Eligibility Criteria

Criteria

• Ages Eligible for Study: 18 Years to 75 Years
• Sexes Eligible for Study: All
• Accepts Healthy Volunteers: No

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.

1. 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

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1	Institut de Cancérologie de l'Ouest Angers	Angers		France	44805
2	CHU Caen	Caen		France	14000
3	CLCC François BACLESSE	Caen		France	14000
4	CLCC Georges François Leclerc	Dijon		France	21079
5	Centre Oscar Lambret	Lille		France	59000
6	CHU Lyon	Lyon		France	69002
7	AP-HM Hôpital Nord	Marseille		France	13005
8	Institut du Cancer de Montpellier	Montpellier		France	34090
9	Institut Curie	Paris		France	75005
10	Hôpital Bichat AP-HP	Paris		France	75018
11	CHU Rennes Hôpital Sud	Rennes		France	35056
12	CHU Rouen	Rouen		France
13	CLCC Henri Becquerel	Rouen		France
14	CHU Strasbourg	Strasbourg		France	67098
15	Institut Claudius Regaud	Toulouse		France	31300
16	CHRU Tours	Tours		France	37044
17	Institut de Cancérologie de Lorraine Nancy	Vandœuvre-lès-Nancy		France	54519
18	Gustave Roussy	Villejuif		France	94800

Sponsors and Collaborators

• Institut Curie

Investigators

None specified.

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.

• Responsible Party: Institut Curie
• ClinicalTrials.gov Identifier: NCT04731610
• Other Study ID Numbers: IC 2020-09 RADIO-RYTHMIC
• First Posted: Feb 1, 2021
• Last Update Posted: Aug 9, 2022
• Last Verified: Aug 1, 2022

• Individual Participant Data (IPD) Sharing Statement: No
• Plan to Share IPD: No
• Studies a U.S. FDA-regulated Drug Product: No
• Studies a U.S. FDA-regulated Device Product: No
• Additional relevant MeSH terms: Thymoma; Thymus Neoplasms

Study Results

No Results Posted as of Aug 9, 2022