Solid Tumor, Adult
Conditions
Keywords
Proton Therapy
Brief summary
This trial will enroll 47 subjects who will be be treated with the IBA PROTEUS® PLUS Proton Beam radiation Therapy (PBT) medical device. The trial aims to assess the safety and efficacy of PROTEUS® PLUS for radiation therapy to oncology patients, and to provide a clinical basis for product registration application.
Detailed description
The trial is structured in two distinct phases. Phase 1 - Clinical Trial: This phase spans from the initial screening through to 90 days post-treatment. Its primary objective is to assess the efficacy and safety of PROTEUS® PLUS in accordance with the regulatory requirements set by the National Medical Products Administration (NMPA) for product registration. Phase 2 - Long-Term Follow-Up: Extending up to five years after treatment, this phase aims to monitor the long-term efficacy and safety of PROTEUS® PLUS. Periodic reports will be submitted in compliance with NMPA guidelines.
Interventions
PROTEUS® PLUS
Sponsors
Ion Beam Applications
Study design
Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
TREATMENT
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
18 Years to 80 Years
Healthy volunteers
No
Inclusion criteria
(main): * Clinically diagnosed with benign/malignant intracranial tumor and malignant solid tumor of head and neck, chest, abdomen, spine, pelvic cavity and limbs * At least 1 lesion of the tumor to be treated is measurable according to RECIST criteria * Expected survival time of more than 6 months * ECOG performance status of 0 to 2 * Negative pregnancy test (HCG) results within 7 days prior to the first treatment for females of childbearing potential
Exclusion criteria
(main): * Contraindications to radiation therapy * Presence of other uncontrolled tumors other than the tumor to be treated * Implants and devices in the treatment area * Re-irradiation * Other conditions that are not suitable for inclusion, as judged by the investigator.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Short term efficacy evaluation | 90 days after the treatment completion | Disease Control Rate (DCR) according to Response Evaluation Criteria in Solid Tumors RECIST Version 1.1 (RECIST 1.1) criteria |
| Short term safety evaluation | 90 days after the treatment completion | Toxicity of grade 3, 4 and 5 according to CTCAE |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Additional short term Safety evaluation | 90 days after the treatment completion | Toxicity of grade 1 and 2 according to CTCAE |
| Long term Efficacy evaluation | 6 months, 1 year, 2 years, and 5 years after the end of the last treatment | Disease Control Rate (DCR) |
| Long term Safety evaluation | 6 months, 1 year, 2 years, and 5 years after the end of the last treatment | Toxicity of grade 1,2, 3, 4 and 5 according to CTCAE |
Countries
China
Outcome results
None listed