Study on Proton Radiotherapy of Thymic Malignancies

Not Applicable

Recruiting

• Conditions: Cardiotoxicity; Pulmonary Toxicity; Thymus Neoplasms
• Interventions: Radiation: Proton radiation

• Registration Number: NCT04822077
• Lead Sponsor: Ass. Prof. Jan Nyman

Brief Summary

This is a multicentre non-randomized phase II study of proton beam radiotherapy in patients with thymic epithelial tumours (i.e. thymoma and thymic carcinoma) in the post-operative setting or in inoperable patients with localized disease.

Patients not willing or for any reason unsuitable to undergo proton treatment will be asked to participate in a follow-up assessment after the regular photon treatment in the same manner as the included patients.

Primary endpoints are:Toxicity (e.g. cardiac and pulmonary toxicity) and Local control at 5 year Secondary endpoints: PFS, Overall survival, Quality of life, measured by EORTC QLQ 30 + LC 13 and relapse pattern

Detailed Description

All doses are recorded in Gy(RBE).

After having checked all eligibility criteria patients will receive:

* Patients with radical surgery and unfavourable histology (B2, B3, C) and/or Masaoka-Koga stage III, IVa: 2 Gy(RBE), once daily, five days a week to a total dose of 50 Gy(RBE).

* Patients with non-radical surgery (R1 resection) regardless of stage and histology: 2.3 Gy(RBE), once daily, 5 days a week to a total dose of 57.5 Gy(RBE)

* Inoperable patients regardless of stage and histology and patients with R2 non-radical resection: 2.5 Gy (RBE), once daily, 5 days a week to a total dose of 62.5 Gy(RBE)

* Patients not willing to participate in study will receive photon therapy according to local practice (≥45 Gy)

Induction or adjuvant chemotherapy may be used according to local practice. Concomitant chemotherapy is not allowed.

Study Timeline

• Study Start: 2018-04-18
• Status Verified: 2021-03
• Study First Submitted: 2021-03-11
• Study First Submitted QC: 2021-03-25
• Last Update Submitted: 2021-03-25
• Study First Posted: 2021-03-30
• Last Update Posted: 2021-03-30
• Primary Completion: 2026-04-01
• Study Completion: 2029-04-01

Recruitment & Eligibility

• Status: RECRUITING
• Sex: All
• Target Recruitment: 40

Inclusion Criteria

• Histological or cytological diagnosis of thymoma or thymic carcinoma.
• With radical surgery: stage III and IVa and selected stage II with type B2, B3 and thymic carcinoma according to local routine. With non-radical surgery (R1 or R2) or inoperable patient/ patient refusing surgery: stage I - IVa, any histology
• PS WHO 0 - 2.
• FEV1 > 1L or >40 % of predicted and CO diffusion capacity > 40% of predicted (postoperative measures)
• Age >18 years, no upper age limit.
• Written informed consent from patients.

Exclusion Criteria

• Masaoka-Koga stage IVb (distant metastases).
• Pregnancy.
• Serious concomitant systemic disorder incompatible with the study.
• Tumour motion > 0.5 cm on two repeated 4DCT

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Arm && Interventions

Group	Intervention	Description
Proton radiotherapy	Proton radiation	Proton radiotherapy with RBE doses: * Patients with radical surgery and unfavourable histology (B2, B3, C) and/or Masaoka-Koga stage III, IVa: 2 Gy(RBE), once daily, five days a week to a total dose of 50 Gy(RBE). * Patients with non-radical surgery (R1 resection) regardless of stage and histology: 2.3 Gy(RBE), once daily, 5 days a week to a total dose of 57.5 Gy(RBE) * Inoperable patients regardless of stage and histology and patients with R2 non-radical resection: 2.5 Gy (RBE), once daily, 5 days a week to a total dose of 62.5 Gy(RBE)

Primary Outcome Measures

Name	Time	Method
Cardiotoxicity and pulmonary toxicity of therapy	At 60 months from treatment	Proportion of patients with cardiac and pulmonary toxicity measured by CTCAE 4.0 \> Grade 2
Local tumor control	At 60 months from treatment	Freedom from tumor progression (CR,PR or SD) mesured by CT-scan

Secondary Outcome Measures

Name	Time	Method
Quality of life questionnaire EORTC QLQ 30 (European Organisation for Research and Treatment of Cancer)	At 60 months from treatment	Scale from 1-100 for 30 items, higher score indicates a better situation.
Quality of life questionnaire LC13 (Lung cancer specific module of EORTC)	At 60 months from treatment	Scale from 1-100 for 13 items and higher score indicates worse symptoms.
Survival	From treatment and for 5 years	Overall survival

Trial Locations

Locations (3)

Department of Oncology, Norrlands Universitetssjukhus; 🇸🇪 Umeå, Norrland, Sweden

Department of Oncology, Sahlgrenska University Hospital; 🇸🇪 Gothenburg, Västra Götaland, Sweden

Department of Oncology, Karolinska University Hospital; 🇸🇪 Stockholm, Stockholm County, Sweden