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NCT Number: NCT04822077

Study on Proton Radiotherapy of Thymic Malignancies

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

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Key information

Conditions

Cardiotoxicity Cardiovascular Diseases Chemically-Induced Disorders Drug-Related Side Effects and Adverse Reactions Heart Diseases Hemic and Lymphatic Diseases Lymphatic Diseases Neoplasms Neoplasms by Histologic Type Neoplasms by Site Neoplasms, Complex and Mixed Pathologic Processes Pathological Conditions, Signs and Symptoms Pulmonary Toxicity Radiation Injuries Thoracic Neoplasms Thymoma Thymus Neoplasms Wounds and Injuries

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Department of Oncology, Norrlands Universitetssjukhus, Umeå, Norrland, Sweden

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About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Proton Radiation

Radiation
  • 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 outcomes

  1. Cardiotoxicity and pulmonary toxicity of therapy

    Time frame: At 60 months from treatment

    Proportion of patients with cardiac and pulmonary toxicity measured by CTCAE 4.0 > Grade 2

  2. Local tumor control

    Time frame: At 60 months from treatment

    Freedom from tumor progression (CR,PR or SD) mesured by CT-scan

Secondary outcomes

  1. Quality of life questionnaire EORTC QLQ 30 (European Organisation for Research and Treatment of Cancer)

    Time frame: At 60 months from treatment

    Scale from 1-100 for 30 items, higher score indicates a better situation.

  2. Quality of life questionnaire LC13 (Lung cancer specific module of EORTC)

    Time frame: At 60 months from treatment

    Scale from 1-100 for 13 items and higher score indicates worse symptoms.

  3. Survival

    Time frame: From treatment and for 5 years

    Overall survival

Study contacts

Contact information is provided by the study sponsor or research team.

Andreas Hallqvist, MD, PhD

CONTACT

[email protected]

+46739845114

Jan Nyman, Ass.prof.

CONTACT

[email protected]

+46313421000 ext. 27927

Sponsors and collaborators

Lead sponsor

Ass. Prof. Jan Nyman

Network

Registry information

Official study title

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

Acronym: PROTHYM

Important dates

Study start
2018
Primary completion
2026
Study completion
2029
First posted
Mar 30, 2021
Registry last updated
Mar 30, 2021

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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