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Prophylactic Radiotherapy Versus Observation for Asymptomatic or Mildly Symptomatic High-Risk Bone Metastases in Lung Cancer: A Single-Center, Randomized, Controlled Phase II Study

Prophylactic Radiotherapy Versus Observation for Asymptomatic or Mildly Symptomatic High-Risk Bone Metastases in Lung Cancer: A Single-Center, Randomized, Controlled Phase II Study

Status
Active, not recruiting
Phases
Unknown
Study type
Interventional
Source
ChiCTR
Registry ID
ChiCTR2500098556
Enrollment
Unknown
Registered
2025-03-10
Start date
2025-04-01
Completion date
Unknown
Last updated
2025-03-17

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

Conditions

Non-small cell lung cancer

Interventions

RT:Prophylactic radiotherapy
Standard of Care:Standard treatment

Sponsors

Zhejiang Cancer Hospital
Lead Sponsor

Eligibility

Sex/Gender
All
Age
18 Years to No maximum

Inclusion criteria

Inclusion criteria: 1. Pathologically confirmed NSCLC; 2. Presence of at least one asymptomatic or mildly symptomatic (no opioid required, NRS=2cm; 2) hip invasion (femoral head, femoral neck and acetabulum); 3) cortical invasion of the long bones (humerus, radius, ulna, clavicle, femur, tibia, fibula, metacarpals, and phalanges) 1/3 to 2/3; 4) invasion of the borderline vertebrae (C7-T1, T12-L1, and L5-S1) or posterior attachment of the vertebral body; 3. Performance status score of 0–2; 4. Age>=18 years; 5. Ability to provide informed consent; 6. Patients of childbearing potential must agree to use an effective method of contraception.

Exclusion criteria

Exclusion criteria: 1. Previous radiation therapy (RT) to the target treatment site; 2. Presence of serious medical comorbidities that preclude the treatment of radiation therapy (RT); 3. Pregnant or lactating females; 4. The target lesion is complex bone metastases, including clinical or radiographic evidence of spinal cord compression or impending pathological fracture of long bones (according to spinal unstable tumor score and Mirels criteria, respectively); 5. Combined with meningeal metastases; 6. Combined with malignant pleural effusion; 7. Absolute neutrophil count (ANC) < 1×10^9/L and platelet count (PLT) < 50×10^9/L at enrollment; 8. If enrollment in the trial would result in a clinical delay in the management of their treatment (e.g. the need for systemic or surgical treatment, and the enrollment trial would delay these treatments); 9. Have participated in clinical studies of other drugs or devices during the same period.

Design outcomes

Primary

MeasureTime frame
Incidence of SREs;

Countries

China

Contacts

Public ContactXiaojing Lai

Zhejiang Cancer Hospital

laixj@zjcc.org.cn+86 571 88122222

Outcome results

None listed

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