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:
2025-12-24 @ 9:33 PM
Ignite Modification Date:
2025-12-24 @ 9:33 PM
NCT ID:
NCT00310232
Eligibility Criteria:
Inclusion Criteria:
1. Histologically confirmed non-small cell lung cancer (squamous cell, large cell, adenocarcinoma, or some combination of these), with clinical or pathological stage III or IV, or recurrent disease; and
2. Hemoglobin level at or below 120 g/L; and
3. At least 18 years of age;
Exclusion Criteria:
1. Systemic platinum-based chemotherapy for lung cancer during the previous two months or planned platinum-based chemotherapy within the next three months;
2. Patients previously treated with high dose thoracic radiation (\>10 fractions), or surgery, without objective evidence of disease recurrence;
3. Planned high dose thoracic radiation therapy (\>10 fractions);
4. A clinically active malignancy, other than the underlying lung cancer which is expected to influence QoL;
5. Expected survival of three months or less;
6. ECOG Performance status of 3 or 4 (see Appendix D);
7. Multiple CNS metastasis or a single CNS lesion that does not demonstrate radiographic stability (Screening CT of head required only if symptomatic, no radiographic follow-up of single resected lesions required);
8. Blood transfusions within the last 14 days;
9. Previous use of erythropoietin;
10. Anemia due to factors other than cancer / radiotherapy (e.g. hemolysis or gastrointestinal bleeding);
11. Evidence of untreated folate or vitamin B12 deficiency;
12. History of uncontrolled hypertension or diastolic blood pressure greater than 100 mm Hg;
13. History of seizure disorder;
14. Known hypersensitivity to mammalian cell-derived products, albumin or any component of the study drug;
15. Pregnancy, lactation or parturition within the previous 30 days;
16. Unwillingness or inability to complete the required QoL questionnaires;
17. Mental incompetence, including psychiatric or addictive disorders which would preclude meaningful completion of questionnaires;
18. Geographically inaccessible for treatment or follow-up evaluations;
19. Currently enrolled in an ongoing therapeutic study;
Healthy Volunteers:
False
Sex:
ALL
Minimum Age:
18 Years
Study:
NCT00310232
Study Brief:
Protocol Section:
NCT00310232