NL-OMON40781
Withdrawn
Phase 2
ungTech Stereotactic Body Radiotherapy (SBRT) of inoperable centrally located NSCLC: A phase II study in preparation for a randomized phase III trial - LungTech
European Organisation for Research in Treatment of Cancer (EORTC)0 sites42 target enrollmentTBD
Overview
- Phase
- Phase 2
- Intervention
- Not specified
- Conditions
- Lung Cancer
- Sponsor
- European Organisation for Research in Treatment of Cancer (EORTC)
- Enrollment
- 42
- Status
- Withdrawn
- Last Updated
- 2 years ago
Overview
Brief Summary
No summary available.
Investigators
Eligibility Criteria
Inclusion Criteria
- •\- Diagnosis of non\-metastatic NSCLC, confirmed by either histology or cytology.
- •\- Centrally located tumor defined as tumor within 2 cm or touching the zone of the proximal bronchial tree or tumor that is immediately adjacent to the mediastinal or pericardial pleura, with a PTV expected to touch or include the pleura.
- •\- Patient deemed medically inoperable after assessment in a multimodality tumor board or refusing surgery.
- •\- Tumor size \* 7 cm (T1\-T3 N0 according to UICC 7th Edition 2011\).
- •\- T3 tumors will be accepted only if one lesion and not abutting the oesophagus.
- •\- Whole body FDG\-PET scan acquired before inclusion, combined with either
- •whole body CT or CT of chest and upper abdomen. In case of uncertainty about involvement of hilar/mediastinal nodes, endobronchial ultrasound\-transbronchial needle aspiration (EBUS\-TBNA) is strongly recommended
- •\- Expert central review of all staging FDG\-PET/CT images before inclusion by an experienced radiation oncologist and a PET/CT specialist.
- •\- Treatment must be planned to start within 6 weeks of FDG\-PET/CT.
- •\- No prior radiotherapy to chest and/or mediastinum
Exclusion Criteria
- •\- Women must not be pregnant
Outcomes
Primary Outcomes
Not specified
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