Trials / Recruiting
RecruitingNCT06542159
Elimination of PTV Margins Based on Online Adaptive Stereotactic Radiotherapy for Early-stage Non-small Cell Lung Cancer or Pulmonary Oligometastases
Elimination of PTV Margins Based on Online Adaptive Stereotactic Radiotherapy for Early-stage Non-small Cell Lung Cancer or Pulmonary Oligometastases: a Prospective, Randomized, Controlled Phase II Study
- Status
- Recruiting
- Phase
- Phase 2
- Study type
- Interventional
- Enrollment
- 130 (estimated)
- Sponsor
- Sun Yat-sen University · Academic / Other
- Sex
- All
- Age
- 18 Years
- Healthy volunteers
- Not accepted
Summary
This study aims to explore the safety and efficacy of eliminating the PTV (planning target volume) margins based on online adaptive stereotactic radiotherapy for patients with early-stage non-small cell lung cancer (NSCLC) or pulmonary oligometastases.
Detailed description
This study aims to explore the safety and efficacy of eliminating the PTV expansion margin based on online adaptive stereotactic body radiotherapy (SBRT) for early-stage non-small cell lung cancer (NSCLC) or pulmonary oligometastases. In this study, patients will be stratified according to whether they have primary early-stage NSCLC, then randomly assigned in a 1:1 ratio to the study group or the control group. Patients in the study group will receive online adaptive SBRT (without PTV expansion margin), while patients in the control group will receive conventional standard SBRT. After the completion of treatment, patients will be followed up regularly to assess safety and efficacy.
Conditions
- Adaptive Radiotherapy
- Stereotactic Body Radiotherapy
- Non-small Cell Lung Cancer
- Lung Oligometastases
- Toxicity
Interventions
| Type | Name | Description |
|---|---|---|
| RADIATION | Online adaptive SBRT | Online adaptive SBRT (without PTV expansion margin). The total dose will be 45-50Gy/3-4 fractions, administered once daily. FBCT and 4DCT will be acquired. |
| RADIATION | Conventional SBRT | SBRT with PTV expansion. The total dose will be 45-50Gy/3-4 fractions, administered once daily. CBCT will be acquired. |
Timeline
- Start date
- 2024-05-22
- Primary completion
- 2027-04-21
- Completion
- 2028-04-21
- First posted
- 2024-08-07
- Last updated
- 2025-11-17
Locations
1 site across 1 country: China
Source: ClinicalTrials.gov record NCT06542159. Inclusion in this directory is not an endorsement.