ungTech Stereotactic Body Radiotherapy (SBRT) of inoperable centrally located NSCLC: A phase II study in preparation for a randomized phase III trial

Phase 2

Withdrawn

• Conditions: Lung Cancer; Non-small-cell lung cancer; 10038666

• Registration Number: NL-OMON40781
• Lead Sponsor: European Organisation for Research in Treatment of Cancer (EORTC)

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Last Update Posted: 23 April 2024

Recruitment & Eligibility

• Status: Withdrawn
• Sex: Not specified
• Target Recruitment: 42

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
- No chemotherapy and/or targeted treatment within 3 months before the start of SBRT
- WHO performance status * 2
- Age * 18 years
- Patients of childbearing / reproductive potential should use adequate birth control measures, during the study treatment period. A highly effective method of birth control is defined as those which result in low failure rate (i.e. less than 1% per year) when used consistently and correctly.
- No other malignancy except adequately treated basal cell carcinoma of the skin or other malignancy from which the patient has been disease free for at least 5 years.
- Absence of any psychological, familial, sociological or geographical condition potentially hampering compliance with the study protocol and follow-up schedule; those conditions should be discussed with the patient before registration in the trial
- Before patient registration, written informed consent must be given according to ICH/GCP, and national/local regulations

Exclusion Criteria

- Women must not be pregnant

Study & Design

• Study Type: Interventional
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
<p>- freedom from local progression at three years</p><br>

Secondary Outcome Measures

Name	Time	Method
<p>- acute and late toxicity<br /><br>- patterns of local and distant recurrence<br /><br>- overall survival and cause of death</p><br>