Clinical trial · Interventional
Irradiation of Large Lung Tumors or Two or More Lung Metastases Simultaneously
VOLUMES Treatment of Larger Tumor Volumes or ≥ 2 Lung Tumors Simultaneously in Lung Cancer Patients Using SBRT in a Mean-lung Dose Escalation Study
NCT01543672CI-TRIAL-00039252VOLUMEScompletedPhase 1 / Phase 2ClinicalTrials.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)
Treatment of larger tumor volumes or ≥ 2 lung metastases simultaneously in lung cancer patient using Stereotactic Body Radiation Therapy (SBRT) in a mean-lung dose escalation study.
Conditions
Conditions (2)
Free-text conditions as registered, with the CancerIndex entity they were reconciled to and the match type.
| Condition (as posted) | Mapped entity | Match | Confidence |
|---|---|---|---|
| Lung Cancer | Malignant Lung Neoplasm | CURATED_EXACT | 0.92 |
| Metastatic Lung Cancer | Malignant Lung Neoplasm | CURATED_BROADER | 0.78 |
Interventions
Interventions (1)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| Stereotactic Body Radiotherapy (SBRT) | Radiation | — | UNRESOLVED |
Design
Arms and outcomes
Arms (2)
- type
- EXPERIMENTAL
- label
- SBRT group A
- description
- escalate MLD in medically inoperable patients with tumors larger than 5 cm in diameter (primary or solitary metastases)
- interventionNames
- Radiation: Stereotactic Body Radiotherapy (SBRT)
- type
- EXPERIMENTAL
- label
- SBRT group B
- description
- Escalate the MLD in patients with ≥ 2 lung metastases
- interventionNames
- Radiation: Stereotactic Body Radiotherapy (SBRT)
Primary outcomes (1)
- measure
- MLD
- timeFrame
- 4 years
Eligibility
Eligibility (as posted)
- Sex
- All
- Minimum age
- 18 Years
Show eligibility criteria text
Inclusion Criteria for group A and B: * Weight loss \< 10% in the last three months. * WHO-performance status ≤ 2 * Medical inoperable patients or patients refusing surgery. * Chemotherapy is allowed in neoadjuvant and adjuvant setting, with exclusion of the period 4 weeks pre-SBRT and 6 weeks post-SBRT. * Before patient registration, written informed consent must be given according to ICH/GCP, national and local regulations. Risk group A specification: * NSCLC (Cytological or histological proven) patients with peripheral tumors \>5 cm with tumor staging cT2bN0M0 or cT3N0M0 (chest wall infiltration is no exclusion criteria, as long as the tumor diameter is \> 5 cm). * Single peripheral lung metastasis in inoperable patients with a diameter of \> 5 cm. In case of first presentation of metastatic disease, cytological or histological proof is obligated. * In patients without cytological or histological confirmation of NSCLC, a growing FDG-PET positive lesion (SUV \>5) is accepted if a contra-indication for invasive diagnostic examination (or refusal) is present. Risk group B specification: * Patients with ≥ 2 simultaneous peripheral lung metastases ≤ 5 cm of any origin at any location in the lung. * In case of first presentation of metastatic disease, cytological or histological proof is obligated. This is not necessary in case of a history of an already proven disseminated disease. * Patients having ≥ 2 peripheral lung metastases without unacceptable dose overlap. Exclusion Criteria: * Patients with central tumors * Pancoast tumors * Prior radiotherapy treatment to the thorax * Patients receiving any systemic treatment during SBRT * Pregnant patients * Patients previously treated with adriamycin agents in case of heart involvement within the treatment field.
References
Publications (0)
Data not yet available
No reference posted for this study.