non-small-cell lung cancer. longkanker
Conditions
Interventions
In the first 10 patients, 3 cycles of cisplatin-pemetrexed will be administered after SRT
In the second arm, 3 identical cycles of chemotherapy will be administered preceding SRT treatment.
Sponsors
prof. dr. EF Smit
Eligibility
Inclusion criteria
Inclusion criteria: 1. Any histologically or cytologically proven NSCLC; 2. Stage IB NSCLC (T2N0M0); 3. FDG-PET scan consistent with stage IB NSCLC; 4. Age 18 years or older; 5. Patients should be fit to undergo chemotherapy and be eligible for SRT using 5 or 8 fractions as specified; 6. Adequate organ function; 7. Signed informed consent; 8. Male and female patients with reproductive potential must use an approved contraceptive method, if appropriate. Female patients with childbearing potential must have a negative serum pregnancy test within 7 days prior to study enrollment.
Exclusion criteria
Exclusion criteria: 1. Pregnant or lactating women; 2. Concomitant treatment with any other experimental drug under investigation; 3. Inability or unwillingness to take folic acid or vitamin B-12 supplementation; 4. Diagnosis of a synchronous second malignancy; 5. Small-Cell Lung cancer (SCLC) or a mixed SCLC-NSCLC; 6. Prior thoracic radiotherapy; 7. Prior systemic anti-cancer chemotherapy.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Safety and feasibility of sequential chemotherapy and SRT. | — |
Secondary
| Measure | Time frame |
|---|---|
| Local control, disease progression and quality of life. | — |
Contacts
Public ContactE.F. Smit
Department of Pulmonary Diseases VU University Medical Centre PO Box 7057
Outcome results
None listed