NCT06524778Not yet recruitingPhase 2
Single High-dose Brachytherapy for Giant Osteosarcoma Masses
The Therapeutic Effect of Single High-dose Brachytherapy for Locally Inoperable and Metastatic Giant Osteosarcoma Masses
Source: ClinicalTrials.gov · Last updated 7 Aug 2024 · Not updated for over 12 months - ask the site whether it is still open
Brief summary (registry, in English)
This study is a prospective, single-arm, phase II, single-center study. Patients with locally unresectable giant osteosarcoma masses who meet the criteria are enrolled in the experimental group, and all patients receive a single dose of 10Gy of implantable brachytherapy. Record treatment-related acute events during and after treatment. Follow up on survival and local control after treatment ends, marking the end of the trial treatment.
- Status (registry)
- Not yet recruiting
- Phase (registry)
- Phase 2
- Study type
- Interventional
- Enrollment
- 16 (estimated)
- First submitted
- 24 Jul 2024
- Start date
- 30 Aug 2024
- Primary completion date
- 30 Jun 2027
- Lead sponsor
- Shanghai Jiao Tong University Affiliated Sixth People's Hospital
- Diseases
- Childhood cancers, Sarcoma
- NCT number
- NCT06524778
What you commit to
- Study type: Interventional · Phase 2
- Planned participants: 16
- From 30 Aug 2024 to the primary completion date, 30 Jun 2027
- No sites listed in no country
- Visits and tests: ask the trial team, the registry does not list them
Built from the registry fields of ClinicalTrials.gov. It describes the study, not your situation.
Who cannot take part
Copied verbatim from ClinicalTrials.gov and grouped by topic. Only the trial team decides who can take part.
Prior treatment
- Local mass previously received radiation therapy;
- Major surgery ≤ 4 weeks before enrollment;
- Previous or concurrent malignant tumors (excluding malignant tumors that have been cured and have a cancer free survival of more than 5 years, such as basal cell carcinoma of the skin and papillary thyroid carcinoma);
Other illness
- Active pulmonary tuberculosis.
Other
- Pregnant or lactating women;
Who the study is looking for
- Pathological diagnosis of osteosarcoma;
- Age range 12-70 years old;
- The primary or metastatic lesion cannot be surgically removed based on clinical evaluation, and treatment with internal medicine multi line chemotherapy, targeted therapy, immunotherapy, etc. is ineffective;
- ECOG physical fitness status is 0-1 points;
- According to RECIST version 1.1 standard, there must be at least one evaluable target lesion with a mass length diameter greater than 5cm;
- Sign a written informed consent form before conducting any experimental activities;
- Researchers determine that they are able to comply with the research protocol;
- Patients who are willing and able to comply with visit arrangements, treatment plans, laboratory tests, and other research procedures.
Age in the registry: 12 years to 70 years · Sex: All · Does not accept healthy volunteers
This page is information, not medical advice. Discuss any trial with your doctor.