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Study on Proton Radiotherapy of Thymic Malignancies (PROTHYM)

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Know the risks and potential benefits of clinical studies and talk to your health care provider before participating. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT04822077
Recruitment Status : Recruiting
First Posted : March 30, 2021
Last Update Posted : March 30, 2021
Sponsor:
Information provided by (Responsible Party):
Ass. Prof. Jan Nyman, Swedish Lung Cancer Study Group

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


Condition or disease Intervention/treatment Phase
Cardiotoxicity Pulmonary Toxicity Thymus Neoplasms Radiation: Proton radiation Not Applicable

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.

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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 40 participants
Allocation: N/A
Intervention Model: Single Group Assignment
Intervention Model Description: Phase II study
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: PROTHYM - Phase II Non-randomized Study on Proton Radiotherapy Of Thymic Malignancies
Actual Study Start Date : April 18, 2018
Estimated Primary Completion Date : April 1, 2026
Estimated Study Completion Date : April 1, 2029

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Thymus Cancer

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)




Primary Outcome Measures :
  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 Outcome Measures :
  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



Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.


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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT04822077


Contacts
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Contact: Jan Nyman, Ass.prof. +46313421000 ext 27927 jan.nyman@oncology.gu.se
Contact: Andreas Hallqvist, MD, PhD +46739845114 andreas.hallqvist@vgregion.se

Locations
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Sweden
Department of Oncology, Norrlands Universitetssjukhus Recruiting
Umeå, Norrland, Sweden, 901 85
Contact: Mikael Johansson, MD PhD    0046703711414    mikael.johansson@onkologi.umu.se   
Contact: Per Bergström, MD PhD       per.bergstrom@vll.se   
Principal Investigator: Mikael Johansson, MD PhD         
Sub-Investigator: Per Bergström, MD         
Department of Oncology, Karolinska University Hospital Not yet recruiting
Stockholm, Stockholm County, Sweden, 171 76
Contact: Signe Friesland, MD PhD       signe.friesland@sll.se   
Contact: Michael Gubanski, MD PhD       michael.gubanski@sll.se   
Principal Investigator: Signe Friesland, MD PhD         
Sub-Investigator: Michael Gubanski, MD PhD         
Department of Oncology, Sahlgrenska University Hospital Recruiting
Gothenburg, Västra Götaland, Sweden, 413 45
Contact: Jan Nyman, Ass prof    0046313427927    jan.nyman@oncology.gu.se   
Contact: Andreas Hallqvist, MD, PhD    +46739845114    andreas.hallqvist@vgregion.se   
Sub-Investigator: Andreas Hallqvist, MD PhD         
Sub-Investigator: Annica Ravn-Fischer, MD phD         
Sub-Investigator: Hillevi Rylander, MD         
Sub-Investigator: Anna Bäck, PhD         
Sub-Investigator: Erik Lundin, MD         
Sub-Investigator: Jens Engleson, MD         
Principal Investigator: Jan Nyman, Ass prof         
Sponsors and Collaborators
Ass. Prof. Jan Nyman
Investigators
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Study Director: Hillevi Rylander, MD Head of Skandion Clinic
  Study Documents (Full-Text)

Documents provided by Ass. Prof. Jan Nyman, Swedish Lung Cancer Study Group:
Study Protocol  [PDF] June 21, 2017

Publications of Results:
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Responsible Party: Ass. Prof. Jan Nyman, Head of Swedish Lung Cancer Study Group, Ass. Prof., Swedish Lung Cancer Study Group
ClinicalTrials.gov Identifier: NCT04822077    
Other Study ID Numbers: PROTHYM 2.2
First Posted: March 30, 2021    Key Record Dates
Last Update Posted: March 30, 2021
Last Verified: March 2021
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No
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.

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Keywords provided by Ass. Prof. Jan Nyman, Swedish Lung Cancer Study Group:
Thymoma
Thymic carcinoma
Proton radiotherapy
Additional relevant MeSH terms:
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Thymus Neoplasms
Thymoma
Cardiotoxicity
Neoplasms
Heart Diseases
Cardiovascular Diseases
Pathologic Processes
Drug-Related Side Effects and Adverse Reactions
Chemically-Induced Disorders
Radiation Injuries
Wounds and Injuries
Thoracic Neoplasms
Neoplasms by Site
Lymphatic Diseases
Neoplasms, Complex and Mixed
Neoplasms by Histologic Type