Study on Proton Radiotherapy of Thymic Malignancies (PROTHYM)

March 25, 2021 updated by: Ass. Prof. Jan Nyman

PROTHYM - Phase II Non-randomized 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

Study Overview

Status

Recruiting

Conditions

Intervention / Treatment

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 Type

Interventional

Enrollment (Anticipated)

40

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Contact Backup

Study Locations

  • Sweden
    • Norrland
      • Umeå, Norrland, Sweden, 901 85
        • Recruiting
        • Department of Oncology, Norrlands Universitetssjukhus
        • Contact:
        • Contact:
        • Principal Investigator:
          • Mikael Johansson, MD PhD
        • Sub-Investigator:
          • Per Bergström, MD
    • Stockholm County
      • Stockholm, Stockholm County, Sweden, 171 76
        • Not yet recruiting
        • Department of Oncology, Karolinska University Hospital
        • Contact:
        • Principal Investigator:
          • Signe Friesland, MD PhD
        • Contact:
        • Sub-Investigator:
          • Michael Gubanski, MD PhD
    • Västra Götaland
      • Gothenburg, Västra Götaland, Sweden, 413 45
        • Recruiting
        • Department of Oncology, Sahlgrenska University Hospital
        • Contact:
        • Sub-Investigator:
          • Andreas Hallqvist, MD PhD
        • Sub-Investigator:
          • Hillevi Rylander, MD
        • Principal Investigator:
          • Jan Nyman, Ass prof
        • Contact:
        • Sub-Investigator:
          • Annica Ravn-Fischer, MD phD
        • Sub-Investigator:
          • Anna Bäck, PhD
        • Sub-Investigator:
          • Erik Lundin, MD
        • Sub-Investigator:
          • Jens Engleson, MD

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

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 Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: N/A
  • Interventional Model: Single Group Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: Proton radiotherapy

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)
Radiation: Proton 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)

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
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
At 60 months from treatment
Local tumor control
Time Frame: At 60 months from treatment
Freedom from tumor progression (CR,PR or SD) mesured by CT-scan
At 60 months from treatment

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
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.
At 60 months from treatment
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.
At 60 months from treatment
Survival
Time Frame: From treatment and for 5 years
Overall survival
From treatment and for 5 years

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Ass. Prof. Jan Nyman

Investigators

  • Study Director: Hillevi Rylander, MD, Head of Skandion Clinic

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

April 18, 2018

Primary Completion (Anticipated)

April 1, 2026

Study Completion (Anticipated)

April 1, 2029

Study Registration Dates

First Submitted

March 11, 2021

First Submitted That Met QC Criteria

March 25, 2021

First Posted (Actual)

March 30, 2021

Study Record Updates

Last Update Posted (Actual)

March 30, 2021

Last Update Submitted That Met QC Criteria

March 25, 2021

Last Verified

March 1, 2021

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • PROTHYM 2.2

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

No

IPD Plan Description

The aim is that the study will be published in international journals. A separate publication will include result of the cardiological data The Vancouver declaration (Br Med J:296, 401-405, 1988) should be followed in all publications based on this study.

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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