Carbon ion reirradiation compared to intensity-modulated re-radiotherapy for recurrent head and neck cancer (CARE): a randomized controlled trial.
Adolescent
Adult
Aged
Aged, 80 and over
Clinical Trials, Phase II as Topic
Female
Head and Neck Neoplasms
/ radiotherapy
Heavy Ion Radiotherapy
/ methods
Humans
Male
Middle Aged
Neoplasm Recurrence, Local
/ radiotherapy
Organs at Risk
/ radiation effects
Prognosis
Prospective Studies
Radiotherapy Dosage
Radiotherapy Planning, Computer-Assisted
/ methods
Radiotherapy, Intensity-Modulated
/ methods
Randomized Controlled Trials as Topic
Squamous Cell Carcinoma of Head and Neck
/ radiotherapy
Young Adult
Head and neck cancer
Heavy ions
Intensity-modulated radiotherapy
Local control
Particle therapy
Reirradiation
Squamous cell carcinoma
Toxicity
Journal
Radiation oncology (London, England)
ISSN: 1748-717X
Titre abrégé: Radiat Oncol
Pays: England
ID NLM: 101265111
Informations de publication
Date de publication:
05 Aug 2020
05 Aug 2020
Historique:
received:
26
06
2020
accepted:
21
07
2020
entrez:
8
8
2020
pubmed:
8
8
2020
medline:
9
6
2021
Statut:
epublish
Résumé
Intensity-modulated re-radiotherapy (reIMRT) has been established as a standard local treatment option in patients with non-resectable, recurrent head and neck cancer (rHNC). However, the clinical outcome is unfavorable and severe toxicities (≥grade III) occurred in 30-40% of patients. The primary aim of the current trial is to investigate carbon ion reirradiation (reCIRT) compared to reIMRT in patients with rHNC regarding safety/toxicity as well as local control, overall survival (OS), and quality of life (QoL). The present trial will be performed as a single center, two-armed, prospective phase II study. A maximum of 72 patients will be treated with either reIMRT or reCIRT to evaluate severe (≥grade III) treatment-related toxicities (randomization ratio 1:1). The primary target value is to generate less than 35% acute/subacute severe toxicity (≥grade III), according to the Common Terminology Criteria for Adverse Events v5.0, within 6 months after study treatment. The total dose of reirradiation will range between 51 and 60 Gy or Gy (RBE), depending primarily on the radiotherapy interval and the cumulative dose to organs at risk. Individual dose prescription will be at the discretion of the treating radiation oncologist. The local and distant progression-free survival 12 months after reirradiation, the OS, and the QoL are the secondary endpoints of the trial. Explorative trial objectives are the longitudinal investigation of clinical patient-related parameters, tumor parameters on radiological imaging, and blood-based tumor analytics. Recent retrospective studies suggested that reCIRT could represent a feasible and effective treatment modality for rHNC. This current randomized prospective trial is the first to investigate the toxicity and clinical outcome of reCIRT compared to reIMRT in patients with rHNC. ClinicalTrials.gov ; NCT04185974 ; December 4th 2019.
Sections du résumé
BACKGROUND
BACKGROUND
Intensity-modulated re-radiotherapy (reIMRT) has been established as a standard local treatment option in patients with non-resectable, recurrent head and neck cancer (rHNC). However, the clinical outcome is unfavorable and severe toxicities (≥grade III) occurred in 30-40% of patients. The primary aim of the current trial is to investigate carbon ion reirradiation (reCIRT) compared to reIMRT in patients with rHNC regarding safety/toxicity as well as local control, overall survival (OS), and quality of life (QoL).
METHODS
METHODS
The present trial will be performed as a single center, two-armed, prospective phase II study. A maximum of 72 patients will be treated with either reIMRT or reCIRT to evaluate severe (≥grade III) treatment-related toxicities (randomization ratio 1:1). The primary target value is to generate less than 35% acute/subacute severe toxicity (≥grade III), according to the Common Terminology Criteria for Adverse Events v5.0, within 6 months after study treatment. The total dose of reirradiation will range between 51 and 60 Gy or Gy (RBE), depending primarily on the radiotherapy interval and the cumulative dose to organs at risk. Individual dose prescription will be at the discretion of the treating radiation oncologist. The local and distant progression-free survival 12 months after reirradiation, the OS, and the QoL are the secondary endpoints of the trial. Explorative trial objectives are the longitudinal investigation of clinical patient-related parameters, tumor parameters on radiological imaging, and blood-based tumor analytics.
DISCUSSION
CONCLUSIONS
Recent retrospective studies suggested that reCIRT could represent a feasible and effective treatment modality for rHNC. This current randomized prospective trial is the first to investigate the toxicity and clinical outcome of reCIRT compared to reIMRT in patients with rHNC.
TRIAL REGISTRATION
BACKGROUND
ClinicalTrials.gov ; NCT04185974 ; December 4th 2019.
Identifiants
pubmed: 32758267
doi: 10.1186/s13014-020-01625-0
pii: 10.1186/s13014-020-01625-0
pmc: PMC7405378
doi:
Banques de données
ClinicalTrials.gov
['NCT04185974']
Types de publication
Clinical Trial Protocol
Journal Article
Langues
eng
Sous-ensembles de citation
IM
Pagination
190Subventions
Organisme : Deutsche Krebshilfe
ID : not applicable
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