Eligibility Module
The Eligibility Module contains detailed information about who can participate in the clinical trial. This includes eligibility criteria, age restrictions, gender requirements, healthy volunteer status, and study population descriptions, helping researchers understand who is eligible to participate in the study.
Eligibility Module path is as follows:
Study -> Protocol Section -> Eligibility Module
Eligibility Module
Ignite Creation Date:
2025-12-26 @ 10:19 PM
Ignite Modification Date:
2025-12-26 @ 10:19 PM
NCT ID:
NCT01577212
Eligibility Criteria:
Inclusion Criteria:
1. Histologically or cytologically confirmed stage IIIA/B NSCLC (excluding pleural effusion and mixed pathology)
2. Irresectable disease (as assessed by multidisciplinary team) or patient refusing surgery
3. Disease which can be encompassed within a radical radiotherapy treatment plan in keeping with standard practice at the participating center
4. Proposed treatment consists of radiotherapy alone or concurrent chemoradiation
5. WHO performance status 0 or 1
6. Adequate respiratory function: FEV1 ≥ 1.5 L and DLCO \> 40%, predicted on baseline pulmonary function tests
7. Age ≥ 18 years, no upper age limit
8. Estimated life expectancy of more than 6 months
9. Patient is available for follow-up
10. Written informed consent obtained
Exclusion Criteria:
1. Clinically diagnosed NSCLC
2. Previous or current malignant disease likely to interfere with the protocol treatment or comparisons
3. Prior thoracic radiotherapy
4. Proposed treatment consist of sequential chemoradiation
5. Prior lobectomy / pneumonectomy
6. Prior chemotherapy using gemcitabine or bleomycine
7. Superior sulcus tumors if the brachial plexus is within the high-dose volume
8. Medically unstable (e.g., ischaemic heart disease, esophageal disorders)
9. Pregnancy
10. Connective tissue disorders
11. Abnormal kidney function interfering with administration of iv contrast agent (GFR\<60)
12. Uncontrolled diabetes mellitus hampering 18FDG-PET
13. Inability to comply with protocol or trial procedures
Healthy Volunteers:
False
Sex:
ALL
Minimum Age:
18 Years
Maximum Age:
85 Years
Study:
NCT01577212
Study Brief:
Protocol Section:
NCT01577212