N/A
Completed N=47
Varian ProBeam Proton Therapy System China Clinical Trial (Hefei)
Tumor, Solid
Source: ClinicalTrials.gov NCT05463055 ↗
Enrolled (actual)
47
Serious AEs
2.1%
Results posted
Nov 2024
Primary outcomePrimary: Percentage of Participants With Disease Control — 100 percentage
Summary
This study is prospective, two-center, single-arm objective performance criteria. This trial will be conducted in 2 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 to evaluate the effectiveness and safety of ProBeam radiotherapy system for oncology patients, providing clinical evidence for the medical device registration.
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Percentage of Participants With Disease Control |
100 | — |
| PRIMARY Percentage of Participants With Common Terminology Criteria for Adverse Events (CTCAE) Grade 3 Toxic Reaction |
— | — |
| PRIMARY Percentage of Participants With Common Terminology Criteria for Adverse Events (CTCAE) Grade 4 and 5 Toxic Reaction |
— | — |
Eligibility Criteria
Inclusion Criteria (Major Criteria):
- 18≤ age≤ 80 years;
- First-diagnosed patients with tumors of the nervous system, head and neck, chest, abdomen, spine, pelvic cavity, limbs, etc. by tissue/cell pathology;
- Eastern Cooperative Oncology Group (ECOG) physical condition is graded as 0 to 2;
- Women of childbearing had negative results in the blood pregnancy test (Human Chorionic Gonadotropin, HCG) 7 days prior to the first treatment;
- 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 (Major Criteria):
- The subject with radiotherapy contraindications, including the known genetic tendencies that increase the sensitivity of normal tissue radiotherapy or the accompanying diseases that lead to hypersensitivity to radiotherapy;
- The subject with other uncontrolled tumors except that to be treated according to medical history or the investigator's estimation, or with other malignant tumors within five years prior to enrollment;
- Implanted pacemakers or other metal prosthesis within the scope of proton therapy;
- Other situations that investigator determines not suitable for enrollment.
Data sourced from ClinicalTrials.gov (NCT05463055). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication. Informational only — not medical advice.