[The preliminary report of a registration clinical trial of proton and heavy ion irradiation].
Zhonghua Zhong Liu Za Zhi
; 40(1): 52-56, 2018 Jan 23.
Article
em Zh
| MEDLINE
| ID: mdl-29365418
ABSTRACT
Objective:
To verify the safety and efficacy of IONTRIS particle therapy system (IONTRIS) in clinical implementation.Methods:
Between 6.2014 and 8.2014, a total of 35 patients were enrolled into this trial 31 males and 4 females with a median age of 69 yrs (range 39-80). Ten patients had locally recurrent head and neck tumors after surgery, 4 cases with thoracic malignancies, 1 case with hepatocellular carcinoma, 1 case with retroperitoneal sarcoma, and 19 cases with non-metastatic prostate carcinomas. Phantom dose verification was mandatory for each field before the start of radiation.Results:
Twenty-two patients received carbon ion and 13 had proton irradiation. With a median follow-up time of 1 year, all patients were alive. Among the 16 patients with head and neck, thoracic, and abdominal/pelvic tumors, 2, 1, 12, and 1 cases developed complete response, partial response, stable disease, or disease progression, respectively. Progression-free survival rate was 93.8% (15/16). Among the 19 patients with prostate cancer, biological-recurrence free survival was 100%. Particle therapy was well tolerated in all 35 patients. Twenty-five patients (71.4%) experienced 33 grade 1 acute adverse effects, which subsided at 1 year follow-up. Six (17.1%) patients developed grade 1 late adverse effects. No significant change in ECOG or body weight was observed.Conclusions:
IONTRIS is safe and effective for clinical use. However, long term follow-up is needed to observe the late toxicity and long term result.Palavras-chave
Texto completo:
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Base de dados:
MEDLINE
Assunto principal:
Neoplasias da Próstata
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Neoplasias Retroperitoneais
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Sarcoma
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Radioterapia com Íons Pesados
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Terapia com Prótons
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Neoplasias de Cabeça e Pescoço
Limite:
Adult
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Aged
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Aged80
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Female
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Humans
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Male
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Middle aged
Idioma:
Zh
Ano de publicação:
2018
Tipo de documento:
Article