Study on Proton Radiotherapy of Thymic Malignancies

Официальное название

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

Обзор

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

Подробное описание

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.

Вмешательства

• Лучевая терапия 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 G

Первичные конечные точки

• Cardiotoxicity and pulmonary toxicity of therapy [Срок оценки: At 60 months from treatment]
• Local tumor control [Срок оценки: At 60 months from treatment]

Вторичные конечные точки (3)

• Quality of life questionnaire EORTC QLQ 30 (European Organisation for Research and Treatment of Cancer) [Срок оценки: At 60 months from treatment]
• Quality of life questionnaire LC13 (Lung cancer specific module of EORTC) [Срок оценки: At 60 months from treatment]
• Survival [Срок оценки: From treatment and for 5 years]

Критерии участия

Критерии включения

• 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.

Критерии исключения

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

Критерии приведены из реестра в оригинале (на английском). Окончательную оценку соответствия проводит исследовательский центр.

Здоровые добровольцы: Нет

Дизайн исследования

Распределение

Не применимо

Модель

Одна группа

Маскирование

Открытое

Основная цель

Лечение

Центры проведения

Швеция · 3 центра

• Department of Oncology, Norrlands Universitetssjukhus — Umeå
• Department of Oncology, Karolinska University Hospital — Stockholm
• Department of Oncology, Sahlgrenska University Hospital — Gothenburg

Публикации

• 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 25260491
• 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 20859129
• 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 26895711
• 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 16332601

Идентификаторы

NCT: NCT04822077 · PROTHYM 2.2

Первоисточники (государственные реестры)

• ClinicalTrials.gov (NIH, США)

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