Study on Proton Radiotherapy of Thymic Malignancies

Not Applicable

Recruiting

• Conditions: Cardiotoxicity; Pulmonary Toxicity; Thymus Neoplasms

• 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

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, Karolinska University Hospital; 🇸🇪 Stockholm, Stockholm County, Sweden

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