Clinical trial · Observational
Stereotactic Radiotherapy With Different Fractionation Modes for the Early Lung Cancer
Clinical Study of Stereotactic Radiotherapy With Different Fractionation Modes for Early Lung Cancer
NCT05802641CI-TRIAL-00065383DSBRT-1unknownClinicalTrials.gov clinicaltrialsProvenance
- Source
- ClinicalTrials.gov
- Retrieved
- Sep 8, 2026
- Layer
- normalized (units and labels harmonized; values unchanged)
- Run
- ING-CLINICALTRIALS-20260908-000001
Summary
Brief summary (as posted)
The goal of this observational study is to study the efficacy and safety of stereotactic body radiotherapy (SBRT) with different fractionation modes for early lung cancer. The main questions it aims to answer are: How effective are different regimens of SBRT for early lung cancer? How safe are different regimens of SBRT of SBRT for early lung cancer?
Conditions
Conditions (4)
Free-text conditions as registered, with the CancerIndex entity they were reconciled to and the match type.
| Condition (as posted) | Mapped entity | Match | Confidence |
|---|---|---|---|
| Fractionation | — | UNRESOLVED | — |
| Lung Cancer | Malignant Lung Neoplasm | CURATED_EXACT | 0.92 |
| Radiotherapy | — | UNRESOLVED | — |
| Stereotactic Body Radiotherapy | — | UNRESOLVED | — |
Interventions
Interventions (1)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| SBRT | Radiation | — | UNRESOLVED |
Design
Arms and outcomes
Arms (2)
- label
- single fraction of SBRT(30Gy/1f)
- description
- Participants with early lung cancer receive single fraction of SBRT(30Gy/1f).
- interventionNames
- Radiation: SBRT
- label
- Multiple fractions of SBRT(36Gy/3f)
- description
- Participants with early lung cancer receive multiple fractions of SBRT(36Gy/3f).
- interventionNames
- Radiation: SBRT
Primary outcomes (1)
- measure
- PFS
- timeFrame
- 2025-01-01
- description
- The time from the date of treatment to the date of disease progression or death or last follow-up.
Secondary outcomes (2)
Eligibility
Eligibility (as posted)
- Sex
- All
- Minimum age
- 18 Years
- Maximum age
- 80 Years
Show eligibility criteria text
Inclusion Criteria: 1. Signed written informed consent; 2. Male or female aged ≥ 18 years and ≤ 75 years; 3. patients with early lung cancer confirmed by pathology or clinical multidisciplinary team (MDT); 4. The ECOG PS was 0 to 1; 5. Survival time ≥3 months; 6. Laboratory results during screening must meet the following requirements: 1. Blood routine: neutrophil absolute count (ANC) ≥ 1.5 × 109/L, platelet count (PLT) ≥ 100 × 109/L, hemoglobin (HGB) ≥ 90 g/L (no blood transfusion or erythropoietin dependence within 7 days); 2. Liver function: total bilirubin (TBIL) ≤ 1.5 times the upper limit of normal value (ULN); Alanine aminotransferase (ALT) and aspartate aminotransferase (AST) were less than 2.5 times ULN in subjects without liver metastasis, and ALT and AST were less than 5 times ULN in subjects with liver metastasis. 3. Renal function: serum creatinine (Cr) ≤1.5 times ULN or Cr clearance ≥60 mL/min (Cockcroft-Gault formula), and urine protein (UPRO) \< on routine urine test; 2+ or 24 h urinary protein quantification \< 1g; 4. International standardized ratio (INR) ≤1.5 times ULN and partial prothrombin time (PTT) or activated partial thrombin time (APTT) ≤1.5 times ULN during the 7 days prior to treatment; Exclusion Criteria: 1. any unstable systemic disease, including but not limited to active infection, congestive heart failure \[New York Heart Association (NYHA) class ≥ II\], severe arrhythmia requiring medical therapy, liver, kidney, or metabolic disease; Type I and type II respiratory failure; 2. other malignancies within 5 years before randomization, except adequately treated cervical carcinoma in situ, basal cell or squamous skin cancer, local prostate cancer after radical surgery, ductal carcinoma in situ after radical surgery, or papillary thyroid cancer;
References
Publications (0)
Data not yet available
No reference posted for this study.