SCLC
Conditions
Interventions
Patients with a response to chemotherapy, will receive prophylactic cranial irradiation 20 Gy in 5 fractions or 30 Gy in 10 fractions 4-5 times per week. And they will be randomized to receive either
Sponsors
VU University medical center
Dept. of Radiation Oncology
Eligibility
Inclusion criteria
Inclusion criteria: - Cytologically or histologically proven small cell lung cancer -Documented extensive disease (see appendix D) before the start of chemotherapy -Any response after 4 to 6 cycles of initial chemotherapy (chemotherapy regimen and response evaluation according to the standard institution policy, provided that none of the existing lesions progressed) -Chemotherapy (preferably platinum-etoposide; other regimens need approval of study-coordinator) completed. A patient can be randomized prior to the end of chemotherapy if the date of last chemotherapy is known and not more than 2 weeks in the future, and if the response criteria are met on the date of randomization. Study treatment should start within 6 weeks after last date of chemotherapy. - Maximum interval of 6 weeks between last chemotherapy administration and randomization -No evidence of brain metastases or leptomeningeal metastases (A contrast enhanced CT MRI scan of the brain is mandatory in case of clinical suspicion of brain metastases) -No evidence of pleural metastases or pleuritis carcinomatosa -No prior radiotherapy to the brain -No prior radiotherapy to the thorax - Age 18 years or older -Performance status 0 to 2 (WHO scale, see Appendix B) -Patient must be willing to receive chest irradiation -Before patient registration/randomization, written informed consent must be given according to ICH/GCP, and national/local regulations -Volume should be encompassable in acceptable radiation fields 14. Volume should be encompassable in acceptable radiation fields.
Exclusion criteria
Exclusion criteria: None
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| The primary endpoint of this trial is to achieve an increase in 1 year survival of 10% (from 27% to 37%; HR=0.76). The Kaplan-Meier method will be used to estimate survival at different time points, and the logrank two sided test will be used to compare therapeutic arms according to the intent to treat policy. | — |
Secondary
| Measure | Time frame |
|---|---|
| The secondary endpoints are local control, pattern of failure and toxicity. Local control is defined as the absence of disease progression in the treated lobe/lung. | — |
Contacts
Public ContactB.J. Slotman
VU University medical center Department of Radiation Oncology P.O.Box 7057
Outcome results
None listed