Carbon Ion Re-Radiotherapy in Patients With Recurrent or Progressive Locally Advanced Head-and-Neck Cancer

Официальное название

Carbon Ion Re-Radiotherapy in Patients With Recurrent or Progressive Locally Advanced Head-and-Neck Cancer: A Phase-II Study to Evaluate Toxicity and Efficacy

Обзор

After multimodal therapy of head-and-neck tumors, patients often develop local recurrence, locally progressive disease or second primary tumors. In this highly pre-treated patient cohort, therapeutic options are limited. Patients that are not candidates for salvage surgery may benefit from re-irradiation. Despite recent technical advances, re-irradiation is associated with severe side effects. Carbon ion Re-Radiotherapy (reCIRT) has shown encouraging results in retrospective analyses with moderate toxicity. In the current Phase-II CARE-trial, reCIRT and conventional photon re-irradiation in patients with recurrent or progressive locally advanced head-and-neck cancer will be assessed regarding toxicity/ safety, local progression-free survival, overall survival and quality-of-life.

Подробное описание

The incidence of head-and-neck cancer worldwide amounts to around 550.000 cases per year, with male patients affected significantly more often. Common risk factors are smoking, alcohol, viral infections, immunodeficiency or genetic factors. Locally advanced head-and-neck tumors can lead to severe symptoms such as dysphagia, cachexia and tumor pain with a significant decrease of the quality-of-life. The prognosis depends on multiple factors such as TNM-staging, tumor volume, histology, general condition, age and smoking. Further risk factors are positive resection margins, extracapsular extension and perineural invasion. While metastatic spread significantly decreases overall survival, the life-limiting problem in patients with head-and-neck cancer is locally invasive and destructive tumor growth leading to a decrease of the performance status and quality of life. After multimodal therapy of locally advanced head-and-neck tumors, around 30 - 50% of patients will develop local recurrence or locally progressive disease and up to 8% of patients with HNSCC will develop a second primary tumor in the head-and-neck .

Вмешательства

• Лучевая терапия C12 re-irradiation
  51 Gy(RBE) or 54 Gy
• Лучевая терапия Photon re-irradiation
  54 Gy(RBE) or 60 Gy

Первичные конечные точки

• safety of carbon ion re-irradiation [Срок оценки: 6 month]
• toxicity of carbon ion re-irradiation [Срок оценки: 6 month]

Вторичные конечные точки (4)

• progression-free survival [Срок оценки: 12 month]
• Overall survival [Срок оценки: 12 month]
• Score on EORTC QLQ C30 Quality of life questionaire [Срок оценки: within 12 month after re-irradiation]
• Score on EORTC QLQ H&N35 Quality of life questionaire [Срок оценки: within 12 month after re-irradiation]

Критерии участия

Критерии включения

• Locally recurrent / progressive head-and-neck cancer after initial radiation therapy
• Microscopic or macroscopic tumor after salvage surgery
• Indication for re-irradiation
• Completed wound healing after surgical intervention
• Karnofsky-Performance-Score ≥ 60
• Age ≥ 18 years
• Written informed consent (must be available before enrolment in the trial)
• Ability of subject to understand character and individual consequences of the trial
• For women with childbearing potential, (and men) adequate contraception
• Submission of previous radiotherapy records

Критерии исключения

• Re-irradiation of malignancy in the larynx
• Diagnosed plasmocytoma, sarcoma or chordoma
• Previous re-irradiation in-field
• Time interval < 6 months after initial radiotherapy
• Distant metastases (except pulmonary metastases)
• Patients who have not recovered from acute toxicities of prior therapies
• Refusal of the patients to take part in the study
• Pregnant or lactating women
• Known carcinoma <5 years ago (excluding Carcinoma in situ of the cervix, basal cell carcinoma, squamous cell carcinoma of the skin) requiring immediate treatment interfering with study therapy
• Participation in another clinical study or observation period of competing trials, respectively

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

Здоровые добровольцы: Нет

Дизайн исследования

Распределение

Рандомизированное

Модель

Параллельные группы

Маскирование

Открытое

Основная цель

Лечение

Центры проведения

Германия · 2 центра

• University Hospital of Heidelberg, Radiation Oncology — Heidelberg
• Philips University Marburg — Marburg

Публикации

• Held T, Lang K, Regnery S, Weusthof K, Hommertgen A, Jakel C, Tonndorf-Martini E, Krisam J, Plinkert P, Zaoui K, Freudlsperger C, Moratin J, Krauss J, Harrabi SB, Herfarth K, Debus J, Adeberg S. Carbon ion reirradiation compared to intensity-modulated re-radiotherapy for recurrent head and neck cancer (CARE): a randomized controlled trial. Radiat Oncol. 2020 Aug 5;15(1):190. doi: 10.1186/s13014-02 PMID 32758267

Идентификаторы

NCT: NCT04185974 · RADONK-CARE-2018

Первоисточники (государственные реестры)

• ClinicalTrials.gov (NIH, США)

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