Single High-dose Brachytherapy for Giant Osteosarcoma Masses

NCT06524778 | Not Yet Recruiting Phase 2 DMC

• 1 other identifier: CSH06R102
• Study Type: interventional
• Target: 16
• Locations: 0 countries
• Sites: N/A

Brief 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.

Conditions

Osteosarcoma

Keywords

brachytherapy; high-dose; osteosarcoma

Outcome Measures

Primary Outcomes (1)

• progression-free survival

  6 months of progression-free survival

  6 months

Secondary Outcomes (4)

• progression-free survival

  12 months

• progression-free survival

  12 months

• OS

  12 months

• Adverse reactions related to radiotherapy

  12 months

Study Arms (1)

brachytherapy

EXPERIMENTAL

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.

Radiation: brachytherapy

Interventions

brachytherapy RADIATION

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.

brachytherapy

Eligibility Criteria

• Age: 12 Years - 70 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17), Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• 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);
• Pregnant or lactating women;
• Active pulmonary tuberculosis.

Sponsors & Collaborators

• Shanghai Jiao Tong University Affiliated Sixth People's Hospital: lead

MeSH Terms

Conditions

Osteosarcoma

Interventions

Brachytherapy

Condition Hierarchy (Ancestors)

Neoplasms, Bone Tissue; Neoplasms, Connective Tissue; Neoplasms, Connective and Soft Tissue; Neoplasms by Histologic Type; Neoplasms; Sarcoma

Intervention Hierarchy (Ancestors)

Radiotherapy; Therapeutics

Central Study Contacts

Xiaojing Yang, Dr

CONTACT

86-21-2405-8972; yangxj717@163.com

Jie Fu, Dr

CONTACT

86 21 24058973; fujie74@sjtu.edu.cn

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Principal Investigator

Model Details: Single dose high-dose （10Gy）implantable brachytherapy

Study Record Dates

• First Submitted: July 24, 2024
• First Posted: July 29, 2024
• Study Start: August 30, 2024
• Primary Completion (Estimated): June 30, 2027
• Study Completion (Estimated): June 30, 2027
• Last Updated: August 7, 2024

Record last verified: 2024-08