Clinical trial · Interventional
Surgery Versus Stereotactic Body Radiation Therapy for Stage up to IA2 (T1a or T1b) Non-small Cell Lung Cancer
NCT03431415CI-TRIAL-00053482RAXSIAwithdrawnN/AClinicalTrials.gov clinicaltrialsProvenance
- Source
- ClinicalTrials.gov
- Retrieved
- Sep 8, 2026
- Layer
- normalized (units and labels harmonized; values unchanged)
- Run
- ING-CLINICALTRIALS-20260908-000001
Why stopped (as posted): Accrual issues
Summary
Brief summary (as posted)
The primary objective of this study is disease free survival rate at 5 years in stage IA2 (T1aN0M0 or T1bN0M0 only) non-small cell lung cancer (NSCLC) patients treated either by surgery or stereotactic body radiation therapy (SBRT).
Conditions
Conditions (3)
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 Cancer Stage I | Lung Non-Small Cell Carcinoma | CURATED_BROADER | 0.78 |
| Stereotactic Body Radiation Therapy | — | UNRESOLVED | — |
| Surgery | — | UNRESOLVED | — |
Interventions
Interventions (2)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| Anatomical Segmentectomy, Lobectomy or Bilobectomy | Procedure | — | UNRESOLVED |
| Stereotactic Body Radiation Therapy | Radiation | — | UNRESOLVED |
Design
Arms and outcomes
Arms (2)
- type
- ACTIVE_COMPARATOR
- label
- Surgery
- description
- Patients that will undergo surgery (anatomical segmentectomy, lobectomy or bilobectomy) as primary lung cancer treatment
- interventionNames
- Procedure: Anatomical Segmentectomy, Lobectomy or Bilobectomy
- type
- ACTIVE_COMPARATOR
- label
- SBRT (Stereotactic Body Radiation Therapy)
- description
- Patients that will undergo SBRT as primary lung cancer treatment
- interventionNames
- Radiation: Stereotactic Body Radiation Therapy
Primary outcomes (1)
- measure
- Disease free survival
- timeFrame
Eligibility
Eligibility (as posted)
- Sex
- All
- Minimum age
- 18 Years
- Maximum age
- 75 Years
Show eligibility criteria text
Inclusion Criteria: * Patients aged 18-75 * Pathologically (histologically or cytologically) proven NSCLC. * Stage IA2 T1aN0M0 or T1bN0M0 only, fit for surgery. * Tumor ≤ 2 cm (T1a or T1b according to AJCC, 8th ed.) * Hilar or mediastinal lymph nodes ≤ 1 cm with no abnormal hilar or mediastinal uptake on PET scan are considered N0. * Patients with hilar or mediastinal lymph nodes \> 1 cm on CT scan or abnormal PET scan (including suspicious but non-diagnostic uptake) are eligible, provided directed tissue biopsies by EBUS or mediastinoscopy of all abnormally identified areas are negative for cancer. * EBUS preferable * No regional or distant metastases. * Resectable disease and treatable by SBRT * Peripherally located tumor. * Primary tumor within or touching the zone of the proximal bronchial tree, defined as a volume of 2 cm in all directions around the proximal bronchial tree are excluded (carina, right and left main bronchi, right and left upper lobe bronchi, intermedius bronchus, right middle lobe bronchus, lingular bronchus, right and left lower lobe bronchi). * No involvement of the central pleura and/or structures of the mediastinum. * Staging studies must be done within 8 weeks prior to study entry * Patients must provide study specific informed consent prior to study entry. Exclusion Criteria: * Previously operated lung cancer. * Previous thoracic irradiation. * Patients with a history of other malignancies, except: adequately treated non-melanoma skin cancer, curatively treated in-situ cancer, or other solid tumors curatively treated with no evidence of disease for ≥ 5 years following the end of treatment and which, in the opinion of the treating physician, do not have a substantial risk of recurrence of the prior malignancy. * Pulmonary nodule manifested as pure ground-glass opacity. * Severe pulmonary hypertension. * Severe cardiac, hepatic or renal insufficiency. * Severe peripheral vascular disease. * Severe cerebral or psychiatric pathologies. * Severe chronic heart disease. * Life expectancy \< 6 months. * Pregnant or lactating woman. * Unwilling to have follow-up. * Central tumor where pneumonectomy might be considered.
References
Publications (0)
Data not yet available
No reference posted for this study.