Clinical trial · Interventional
Risk-adapted Stereotactic Body Radiotherapy for Early Non-Small Cell Lung Cancer Using the VERO Stereotactic Body Radio Therapy System
Phase II Protocol for Risk-adapted Stereotactic Body Radio Therapy for Stage T1-T3N0 Non-Small Cell Lung Carcinoma
- 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 purpose of this study is to perform prospective data analysis on tumor response in terms of local tumor control after 2 years, potential acute and late toxicity and survival in patients with non-metastatic, non-small-cell lung cancer treated by radiotherapy that are medically inoperable due to coexisting comorbidities or that refuse surgery. SBRT regimens used will be 4 fractions of 12 Gy or 3 fractions of 17 Gy depending on tumor location in a risk-adapted approach.
Conditions
Conditions (1)
Free-text conditions as registered, with the CancerIndex entity they were reconciled to and the match type.
| Condition (as posted) | Mapped entity | Match | Confidence |
|---|---|---|---|
| Non-Small Cell Lung Carcinoma | Lung Non-Small Cell Carcinoma | ALIAS | 0.90 |
Interventions
Interventions (1)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| Radiotherapy (Fractionated stereotactic body radiation) | Radiation | — | UNRESOLVED |
Design
Arms and outcomes
Arms (1)
- type
- EXPERIMENTAL
- label
- Radiotherapy
- description
- For centrally located T1 and T2 lesions 4 x 12 Gy over 2 weeks will be delivered. Lesions located peripherally will be treated with 3 x 17 Gy, also delivered within 2 weeks. For both schedules, there should be a minimum of 40 hours and a maximum of 8 days between 2 separate fractions. There should be a maximum of 2 fractions per week.
- interventionNames
- Radiation: Radiotherapy (Fractionated stereotactic body radiation)
Primary outcomes (1)
- measure
- Toxicity of grade 3+ as assessed by NCI CTCAE v4.0
- timeFrame
- From start of SBRT until 1 year. After 1 year until end of follow-up for late toxicity
- description
- To monitor potential toxicity in patients with stage T1,T2,T3 N0 non-small cell lung carcinoma (NSCLC), treated with primary stereotactic body radiation therapy (SBRT)
Secondary outcomes (1)
Eligibility
Eligibility (as posted)
- Sex
- All
- Minimum age
- 18 Years
- Maximum age
- 90 Years
Show eligibility criteria text
Inclusion Criteria: 1. Stage T1,T2,T3N0M0 NSCLC, histological confirmation either by biopsy or cytology 2. Maximal tumor diameter of 6 cm 3. Only T3 lesions based upon thoracic wall involvement, only 1 lesion 4. Informed consent is required 5. Life expectancy of at least 6 months 6. Age \>/= 18 y. 7. Karnofsky score ≥ 70 or ECOG score ≤ 2 8. Inoperable patients or patients refusing surgery 9. Patients with measurable lesion (according to RECIST criteria) Exclusion Criteria: 1. Diagnosis of small cell lung cancer 2. Lymph node involvement 3. Prior radiotherapy to the chest and/or mediastinum 4. No chemotherapy and/or targeted treatment within 3 months before SBRT 5. Pregnant or lactating women 6. Known allergy for CT contrast 7. No FDG-PET 8. Mental condition rendering the patient unable to understand the nature, scope, and possible consequences of the study. 9. Patient unlikely to comply with protocol, i.e., uncooperative attitude, inability to return for follow-up visits, extreme degradation of lung function tests and patients not likely to complete the study.
References
Publications (1)
- DERIVEDLevy A, Guckenberger M, Hurkmans C, Nestle U, Belderbos J, De Ruysscher D, Faivre-Finn C, Le Pechoux C. SBRT Dose and Survival in Non-Small Cell Lung Cancer: In Regard to Koshy et al. Int J Radiat Oncol Biol Phys. 2015 Jul 15;92(4):945-6. doi: 10.1016/j.ijrobp.2015.03.032. No abstract available. PMID 26104945