NCT04822077

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

Trial Health

77
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
40

participants targeted

Target at P25-P50 for not_applicable

Timeline
35mo left

Started Apr 2018

Longer than P75 for not_applicable

Geographic Reach
1 country

3 active sites

Status
recruiting

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Progress74%
Apr 2018Apr 2029

Study Start

First participant enrolled

April 18, 2018

Completed
2.9 years until next milestone

First Submitted

Initial submission to the registry

March 11, 2021

Completed
19 days until next milestone

First Posted

Study publicly available on registry

March 30, 2021

Completed
5 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

April 1, 2026

Completed
3 years until next milestone

Study Completion

Last participant's last visit for all outcomes

April 1, 2029

Expected
Last Updated

March 30, 2021

Status Verified

March 1, 2021

Enrollment Period

8 years

First QC Date

March 11, 2021

Last Update Submit

March 25, 2021

Conditions

CardiotoxicityPulmonary ToxicityThymus Neoplasms

Keywords

ThymomaThymic carcinomaProton radiotherapy

Outcome Measures

Primary Outcomes (2)

  • Cardiotoxicity and pulmonary toxicity of therapy

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

    At 60 months from treatment

  • Local tumor control

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

    At 60 months from treatment

Secondary Outcomes (3)

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

    At 60 months from treatment

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

    At 60 months from treatment

  • Survival

    From treatment and for 5 years

Study Arms (1)

Proton radiotherapy

EXPERIMENTAL

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

Interventions

Proton radiationRADIATION

* 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)

Proton radiotherapy

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • 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.

You may not qualify if:

  • Masaoka-Koga stage IVb (distant metastases).
  • Pregnancy.
  • Serious concomitant systemic disorder incompatible with the study.
  • Tumour motion \> 0.5 cm on two repeated 4DCT

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (3)

Department of Oncology, Norrlands Universitetssjukhus

Umeå, Norrland, 901 85, Sweden

RECRUITING

Department of Oncology, Karolinska University Hospital

Stockholm, Stockholm County, 171 76, Sweden

NOT YET RECRUITING

Department of Oncology, Sahlgrenska University Hospital

Gothenburg, Västra Götaland County, 413 45, Sweden

RECRUITING

Related Publications (4)

  • Chang JY, Li H, Zhu XR, Liao Z, Zhao L, Liu A, Li Y, Sahoo N, Poenisch F, Gomez DR, Wu R, Gillin M, Zhang X. Clinical implementation of intensity modulated proton therapy for thoracic malignancies. Int J Radiat Oncol Biol Phys. 2014 Nov 15;90(4):809-18. doi: 10.1016/j.ijrobp.2014.07.045. Epub 2014 Sep 24.

    PMID: 25260491RESULT

  • Gomez D, Komaki R. Technical advances of radiation therapy for thymic malignancies. J Thorac Oncol. 2010 Oct;5(10 Suppl 4):S336-43. doi: 10.1097/JTO.0b013e3181f20ea2.

    PMID: 20859129RESULT

  • Vogel J, Berman AT, Lin L, Pechet TT, Levin WP, Gabriel P, Khella SL, Singhal S, Kucharczuk JK, Simone CB 2nd. Prospective study of proton beam radiation therapy for adjuvant and definitive treatment of thymoma and thymic carcinoma: Early response and toxicity assessment. Radiother Oncol. 2016 Mar;118(3):504-9. doi: 10.1016/j.radonc.2016.02.003. Epub 2016 Feb 16.

    PMID: 26895711RESULT

  • Bjork-Eriksson T, Bjelkengren G, Glimelius B. The potentials of proton beam radiation therapy in malignant lymphoma, thymoma and sarcoma. Acta Oncol. 2005;44(8):913-7. doi: 10.1080/02841860500355983.

    PMID: 16332601RESULT

MeSH Terms

Conditions

CardiotoxicityThymus NeoplasmsThymoma

Interventions

Proton Therapy

Condition Hierarchy (Ancestors)

Heart DiseasesCardiovascular DiseasesPathologic ProcessesPathological Conditions, Signs and SymptomsDrug-Related Side Effects and Adverse ReactionsChemically-Induced DisordersRadiation InjuriesWounds and InjuriesThoracic NeoplasmsNeoplasms by SiteNeoplasmsLymphatic DiseasesHemic and Lymphatic DiseasesNeoplasms, Complex and MixedNeoplasms by Histologic Type

Intervention Hierarchy (Ancestors)

Heavy Ion RadiotherapyRadiotherapyTherapeutics

Study Officials

  • Hillevi Rylander, MD

    Head of Skandion Clinic

    STUDY DIRECTOR

Central Study Contacts

Jan Nyman, Ass.prof.

CONTACT

+46313421000jan.nyman@oncology.gu.se

Andreas Hallqvist, MD, PhD

CONTACT

+46739845114andreas.hallqvist@vgregion.se

Study Design

Study Type
interventional
Phase
not applicable
Allocation
NA
Masking
NONE
Purpose
TREATMENT
Intervention Model
SINGLE GROUP
Model Details: Phase II study
Sponsor Type
NETWORK
Responsible Party
SPONSOR INVESTIGATOR
PI Title
Head of Swedish Lung Cancer Study Group, Ass. Prof.

Study Record Dates

First Submitted

March 11, 2021

First Posted

March 30, 2021

Study Start

April 18, 2018

Primary Completion

April 1, 2026

Study Completion (Estimated)

April 1, 2029

Last Updated

March 30, 2021

Record last verified: 2021-03

Data Sharing

IPD Sharing
Will not share

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.

Locations

SE(3)