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Study on Proton Radiotherapy of Thymic Malignancies

PROTHYM - Phase II Non-randomized Study on Proton Radiotherapy Of Thymic Malignancies

Status
Recruiting
Phases
NA
Study type
Interventional
Source
ClinicalTrials.gov
Registry ID
NCT04822077
Acronym
PROTHYM
Enrollment
40
Registered
2021-03-30
Start date
2018-04-18
Completion date
2029-04-01
Last updated
2021-03-30

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Cardiotoxicity, Pulmonary Toxicity, Thymus Neoplasms

Keywords

Thymoma, Thymic carcinoma, Proton radiotherapy

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.

Interventions

* 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)

Sponsors

Ass. Prof. Jan Nyman
Lead SponsorNETWORK

Study design

Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
TREATMENT
Masking
NONE

Intervention model description

Phase II study

Eligibility

Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No

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

Design outcomes

Primary

MeasureTime frameDescription
Cardiotoxicity and pulmonary toxicity of therapyAt 60 months from treatmentProportion of patients with cardiac and pulmonary toxicity measured by CTCAE 4.0 \> Grade 2
Local tumor controlAt 60 months from treatmentFreedom from tumor progression (CR,PR or SD) mesured by CT-scan

Secondary

MeasureTime frameDescription
Quality of life questionnaire EORTC QLQ 30 (European Organisation for Research and Treatment of Cancer)At 60 months from treatmentScale 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 treatmentScale from 1-100 for 13 items and higher score indicates worse symptoms.
SurvivalFrom treatment and for 5 yearsOverall survival

Countries

Sweden

Contacts

Primary ContactJan Nyman, Ass.prof.
jan.nyman@oncology.gu.se+46313421000
Backup ContactAndreas Hallqvist, MD, PhD
andreas.hallqvist@vgregion.se+46739845114

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026