An interventional study of Proton radiation therapy in Solid Tumor, Radiation Therapy and Proton Therapy, sponsored by Guangzhou Concord Cancer Center. Completed at 1 site in China. Open to participants aged 18 Years to 80 Years. Per ClinicalTrials.gov, last updated 2023-11-07.
Sponsored by Guangzhou Concord Cancer Center · Not applicable, Interventional, and Treatment
This study is a clinical trial of prospective, single-arm objective performance criteria. This trial will be conducted in clinical trial sites with a total of 47 subjects enrolled. All of subjects will be treated with radiation therapy using the medical device Varian ProBeam Proton Therapy System (ProBeam), aim to compare the data with objective performance criteria (OPC) to evaluate the effectiveness and safety of ProBeam radiotherapy system for oncology patients, providing a clinical basis for the medical device registration.
Oncology patients, including tumors of the nervous system, head and neck, chest, abdomen, spine, pelvic cavity, limbs and other tumors. The screening period from informed consent to enrollment is expected to be 4 weeks, while the treatment period is 1 to 8 weeks. The period after the last treatment is divided into short-term follow-up and long-term follow-up, in which short-term follow-up will be 3 months after the end of the last treatment. Total expected participation for each subject from screening to the completion of short-term follow-up is a maximum duration of 12 weeks + 3 months. Long-term follow-up continues after the end of short-term follow-up until the 5th year after the end of the last radiotherapy session.
9,365 studies on the registry are indexed under Neoplasms; 2,489 are open to participants now.
This study's enrollment of 47 is close to the median of 50 across 7,253 interventional studies indexed under Neoplasms.
Browse Neoplasms studies →Guangzhou Concord Cancer Center is the lead sponsor of 5 studies on the registry; 4 are open to participants now.
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1.18≤ age≤ 80 years;
2.First-diagnosed patients with tumors of the nervous system, head and neck, chest, abdomen, spine, pelvic cavity, limbs, etc. by tissue/cell pathology;
3.ECOG physical condition is graded as 0 to 2;
4.Women of childbearing had negative results in the blood pregnancy test (Human Chorionic Gonadotropin, HCG) 7 days prior to the first treatment;
5.The subject or subject's guardian is able to understand the purpose of the study, demonstrate sufficient compliance with the protocol and sign informed consent form
Exclusion Criteria:
Experimental: single-arm objective performance criteria, OPC
Device: Proton radiation therapy
Radiation: Proton Therapy System (ProBeam)
tumor disease control rate reaches the objective performance criteria
After treatment, CR, PR, SD is considered disease control; Percentage of subjects who developed disease control 3 months after the end of the last radiotherapy session.
Time frame: 3 months ± 7 days after the last treatment
CTCAE level 3 toxic reaction ratio is lower than the acceptable value
The proportion of subjects whose toxicity reaction is level 3 during the clinical trial period. The researchers record AE that appeared during the clinical trial cycle and grade it according to CTCAE 5.0
Time frame: started from subject enrollment to 3 months ± 7 days after the last treatment, up to 5 months
CTCAE level 4 and 5 toxic reaction ratio is acceptable value
The proportion of subjects with toxic reactions of levels 4 and 5 during the clinical trial period.The researchers record AE that appeared during the clinical trial cycle and grade it according to CTCAE 5.0)
Time frame: the entire clinical trial ( until 3 months after last treatment)
Objective Response Rate (ORR)
The appearance of CR or PR after treatment is considered objective response, Percentage of subjects who experienced objective response at each point in time after the end of the last treatment
Time frame: screening, 1 months ± 7 days, 2 months ± 7 days, 3 months ± 7 days after the last treatment
Duration of Response (DOR)
The duration of the tumor's first assessment as CR or PR, until the first assessment of PD or death due to any cause.
Time frame: screening, 1 months ± 7 days, 2 months ± 7 days, 3 months ± 7 days after the last treatment
Disease Control Rate (DCR)
CR, PR, SD for disease control after treatment
Time frame: screening, 1 months ± 7 days, 2 months ± 7 days, 3 months ± 7 days after the last treatment
tumor markers (if applicable), Tumor-specific symptoms
Tumor markers are examined and the researchers determine the clinical significance of reporting changes in tumor markers (before and after radiation therapy). The symptoms may be recorded according to the disease, and the researchers determine the clinical significance of reporting symptoms (before and after radiation therapy)
Time frame: screening, 1 months ± 7 days, 2 months ± 7 days, 3 months ± 7 days after the last treatment
actual situation of Product usability evaluation (ProBeam system, Oncology Information system (OIS), Treatment plan system (Eclipse))
Researchers using the appropriate functions scored according to the Likert scale and collected open questions to evaluate the comprehensive feeling of ease of use during treatment.
Time frame: screening, 1 months ± 7 days, 2 months ± 7 days, 3 months ± 7 days after the last treatment
CTCAE level 1 and 2 toxic reaction ratio, Adverse Events (AE) rate, Serious Adverse Events (SAE) rate
The proportion of subjects who had toxic reactions of levels 1 and 2 during the clinical trial period.The researchers record AE that appeared during the clinical trial cycle and grade it according to CTCAE 5.0
Time frame: screening, 1 months ± 7 days, 2 months ± 7 days, 3 months ± 7 days after the last treatment
lab test, Eastern Cooperative Oncology Group (ECOG) grade
Conduct a laboratory examination and the researchers will judge the clinically significant changes in the reporting laboratory indicators. ECOG physical condition grading assessment, and the researchers judge the report of the results clinical significance of the change.
Time frame: screening, 1 months ± 7 days, 2 months ± 7 days, 3 months ± 7 days after the last treatment
tumor recurrence rate
The rate of tumor recurrence is the ratio of the number of subjects who have relapsed to the total number of subjects. The CT or MRI imaging changes of tumors before and after treatment will be evaluated by an imaging review team based on RECIST 1.1
Time frame: screening, 1 months ± 7 days, 2 months ± 7 days, 3 months ± 7 days after the last treatment
Plan to share: No
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Guangzhou Concord Cancer Center