To hear about similar clinical trials, please enter your email below
Trial Title:
Single High-dose Brachytherapy for Giant Osteosarcoma Masses
NCT ID:
NCT06524778
Condition:
Osteosarcoma
Conditions: Official terms:
Osteosarcoma
Conditions: Keywords:
brachytherapy
high-dose
osteosarcoma
Study type:
Interventional
Study phase:
Phase 2
Overall status:
Not yet recruiting
Study design:
Allocation:
N/A
Intervention model:
Single Group Assignment
Intervention model description:
Single dose high-dose （10Gy）implantable brachytherapy
Primary purpose:
Treatment
Masking:
None (Open Label)
Intervention:
Intervention type:
Radiation
Intervention name:
brachytherapy
Description:
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.
Arm group label:
brachytherapy
Summary:
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.
Detailed description:
Screening period: Local MRI or CT examination, blood routine and coagulation function
test.
Selected treatment period: All enrolled patients received one dose of close range
interstitial radiotherapy with a radiation dose of 10 Gy. The number of insertion needles
depends on the size and location of the tumor. The instrument used for radiotherapy is
the Medda high-dose rate brachytherapy machine, and the radiation source is 192 iridium.
Record treatment related acute events such as bleeding during the treatment period.
Follow up: Follow up with local MRI or CT at 1 month, 3 months, 6 months, and 1 year
after the end of radiotherapy treatment to evaluate the treatment effect; Simultaneously
follow up with patients for survival and treatment related adverse reactions, such as
dermatitis, infections, etc.
Criteria for eligibility:
Criteria:
Inclusion Criteria:
1. Pathological diagnosis of osteosarcoma;
2. Age range 12-70 years old;
3. 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;
4. ECOG physical fitness status is 0-1 points;
5. According to RECIST version 1.1 standard, there must be at least one evaluable
target lesion with a mass length diameter greater than 5cm;
6. Sign a written informed consent form before conducting any experimental activities;
7. Researchers determine that they are able to comply with the research protocol;
8. Patients who are willing and able to comply with visit arrangements, treatment
plans, laboratory tests, and other research procedures.
Exclusion Criteria:
1. Local mass previously received radiation therapy;
2. Major surgery ≤ 4 weeks before enrollment;
3. 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);
4. Pregnant or lactating women;
5. Active pulmonary tuberculosis.
Gender:
All
Minimum age:
12 Years
Maximum age:
70 Years
Healthy volunteers:
No
Start date:
August 30, 2024
Completion date:
June 30, 2027
Lead sponsor:
Agency:
Shanghai Jiao Tong University Affiliated Sixth People's Hospital
Agency class:
Other
Source:
Shanghai Jiao Tong University Affiliated Sixth People's Hospital
Record processing date:
ClinicalTrials.gov processed this data on November 12, 2024
Source: ClinicalTrials.gov page:
https://clinicaltrials.gov/ct2/show/NCT06524778
