The preliminary report of a registration clinical trial of proton and heavy ion irradiation

Jiade LU; Ming YE; Xiaomao Guo; Shen FU; F Michael Moyers; Qing Zhang; Jingfang Mao; Lin Kong; Wen Chien Hsi; Kambiz Shahnazi; Jingfang Zhao; Zhen Zhang; Xiumei MA; Songtao Lai; Xiaomeng Zhang; Ningyi MA; Yunsheng Gao; Xin Cai; Xiyin Guan; Junhua Zhang; Bin WU; Jingyi Cheng; Yin-xiang-zi Sheng; Wei Ren; Jun Zhao; Lining Sun; Guoliang Jiang

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The preliminary report of a registration clinical trial of proton and heavy ion irradiation

VernacularTitle: 质子重离子肿瘤放疗的临床注册试验初步报告
Author: Jiade LU ¹ ; Ming YE ² ; Xiaomao GUO ^{1
,

3} ; Shen FU ^{1
,

3} ; F. Michael MOYERS ⁴ ; Qing ZHANG ¹ ; Jingfang MAO ^{1
,

3} ; Lin KONG ^{1
,

3} ; Wen Chien HSI ⁴ ; Kambiz SHAHNAZI ⁴ ; Jingfang ZHAO ^{3
,

4} ; Zhen ZHANG ^{1
,

3} ; Xiumei MA ² ; Songtao LAI ⁵ ; Xiaomeng ZHANG ^{1
,

3} ; Ningyi MA ¹ ; Yunsheng GAO ⁶ ; Xin CAI ¹ ; Xiyin GUAN ¹ ; Junhua ZHANG ⁵ ; Bin WU ^{7
,

8} ; Jingyi CHENG ^{9
,

10} ; Yin-xiang-zi SHENG ⁴ ; Wei REN ⁴ ; Jun ZHAO ^{3
,

4} ; Lining SUN ^{3
,

4} ; Guoliang JIANG ^{1
,

3}
Author Information

1. Department of Radiation Oncology, Shanghai Proton and Heavy Ion Center, Shanghai 201315, China
2. Department of Radiation Oncology, Renji Hospital, Shanghai Jiao Tong University School of Medicine, Shanghai 200127, China
3. Department of Radiation Oncology, Fudan University Cancer Hospital, Shanghai 200032, China
4. Department of Medical Physics, Shanghai Proton and Heavy Ion Center, Shanghai 201315, China
5. Department of Radiation Oncology, Fudan University Cancer Hospital, Shanghai 200032, China
6. Department of Radiation Oncology, Ruijin Hospital, Shanghai Jiao Tong University School of Medicine, Shanghai 200025, China
7. Department of Radiology, Shanghai Proton and Heavy Ion Center, Shanghai 201315, China
8. Department of Radiology, Fudan University Cancer Hospital, Shanghai 200032, China
9. Department of Nuclear Medicine, Shanghai Proton and Heavy Ion Center, Shanghai 201315, China
10. Department of Nuclear Medicine, Fudan University Cancer Hospital, Shanghai 200032, China
Publication Type:Clinical Trail
Keywords: Neoplasms; Proton; Carbon ion; Radiotherapy; Clinical trial
From: Chinese Journal of Oncology 2018;40(1):52-56
CountryChina
Language:Chinese
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.