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The therapeutic effect and safety evaluation of the simultaneous integrated boost radiotherapy model for bone metastatic malignant tumors based on TOMO technique.

The therapeutic effect and safety evaluation of the simultaneous integrated boost radiotherapy model for bone metastatic malignant tumors based on TOMO technique

Status
Recruiting
Phases
Unknown
Study type
Interventional
Source
ChiCTR
Registry ID
ChiCTR1800015955
Enrollment
Unknown
Registered
2018-05-02
Start date
2018-05-01
Completion date
Unknown
Last updated
2018-05-07

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

cancer

Interventions

Group A:PGTV 4Gy*10f,PTV 3Gy*10f
Group B:PTV 3Gy*10f

Sponsors

Department of Oncology, Drum Tower Hospital Affiliated to Medical School of Nanjing University
Lead Sponsor

Eligibility

Sex/Gender
All
Age
18 Years to 75 Years

Inclusion criteria

Inclusion criteria: 1. Aged 18 to 75 years; 2. The primary solid tumor has a definite pathological diagnosis; 3. The radiographic assessment (CT, MR and PET - CT) with clear for bone metastatic malignant tumor, at least 1 painful metastatic disease stove is greater than 2 cm in diameter, pain score > 3 points or need opioid pain control; Painful bone metastasis lesion was less than 3; 4. ECOG score less than 3; 5. The expected survival period longer than six months; 6. No chemotherapy was given within 1 week before randomization; 7. The treatment site has not received radiotherapy before; 8. The following hematological indicators should be met: Neutrophil count is greater than 1.5 x 10^9/L; Hemoglobin is greater than 9g/dL; Platelet count is greater than 70 x 10^9/L; 9. The following biochemical indicators need to be met: Total bilirubin < 1.5x normal value upper limit (ULN); AST and ALT < 1.5 x ULN; Creatinine clearance rate is greater than 60ml/min; 10. Appropriate protective measures (contraceptive measures or other methods of birth control) should be taken before and during the induction period; 11. Informed consent has been signed; 12. Be able to follow the research programme and follow up procedures.

Exclusion criteria

Exclusion criteria: 1. Primary tumor is myeloma and lymphoma. 2. Radiotherapy before radiotherapy. 3. The treatment site was treated with radiotherapy. 4. The treatment site is pathological fracture. 5. Painful bone metastatic lesions >3 patients. 6. ECOG score >3. 7. Chemotherapy in the week before randomization. 8. Significant neurological and psychiatric history, including dementia that may affect understanding and informed consent. 9. Patients with active bacteria, virus or fungal infection (>= 2 grade of nci-ctc, 4th edition) 10. Patients with severe liver and kidney function disorders, HIV infection, HCV infection, uncontrollable coronary artery disease or asthma, uncontrollable cerebrovascular disease group or researchers think they should not enter into the other disease 11. Pregnant and lactating women. Women of childbearing age must test negative pregnancy test within 7 days prior to entry. 12. Drug abuse, clinical or psychological or social factors have affected informed consent or research implementation. 13. Any uncertain factors affecting the safety or compliance of patients.

Design outcomes

Primary

MeasureTime frame
pain scoring;time of pain control;

Secondary

MeasureTime frame
life quality;Progress free time;

Countries

China

Contacts

Public ContactJing Yan

Nanjing Drum Tower Hospital

firefreebird@163.com+86 15805182426

Outcome results

None listed

Source: ChiCTR (via WHO ICTRP) · Data processed: Feb 4, 2026