Patients with locally advanced (stages II-IIIB) non-small cell lung cancer who are eligible for high-dose radiotherapy following the completion of induction systemic chemotherapy.
Conditions
Sponsors
VU University Medical Center
Eligibility
Sex/Gender
All
Inclusion criteria
Inclusion criteria: Patients aged 18 years or older with histologically- or cytologically-confirmed non-squamous cell carcinoma of the lung Inoperable stages II–IIIB NSCLC, who have received no previous thoracic radiotherapy AND no chemotherapy or anti-cancer agents for at least 21 days WHO performance score of 0-2; acceptable pulmonary function as defined by a Fev1 of =30% and a DLCO of =40% of predicted; no use of anticoagulants. Only patients who are not at high risk for radiation pneumonitis (V20 > 35%) are eligible. The maximum spinal cord dose will be limited to 32 Gy, 36 Gy and 40 Gy in successive cohorts. When total dose delivered is limited by either spinal or lung doses, all treated patients will still be eligible for toxicity evaluation. Additional patients will also be recruited in order to ensure that the minimum required number of patients will be treated to 66 Gy. Are the trial subjects under 18? no Number of subjects for this age range: F.1.2 Adults (18-64 years) yes F.1.2.1 Number of subjects for this age range F.1.3 Elderly (>=65 years) yes F.1.3.1 Number of subjects for this age range
Exclusion criteria
Exclusion criteria: 1. Mixed tumor types with small cell lung cancer or squamous cell carcinoma 2. Other serious diseases, such as heart failure, angina pectoris, myocardial infarction within the last 6 months, uncontrolled hypertension 3. Serious non-healing wound or ulcer. 4. ASAT and ALAT > 1,5 x UNL 5. alkaline phosphatase 5 x UNL 6. Evidence of bleeding diathesis or coagulopathy. 7. Any psychological, familial, sociological or geographical condition potentially hampering compliance with the study protocol and follow-up schedule; those conditions should be assessed with the patient before registration in the trial. 8. Participation in other trial with investigational drug or treatment modality.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Main Objective: To establish the safety and tolerability of (1) three doses of bevacizumab at 7.5 mg/kg or 15 mg/kg administered every 3 weeks with concurrent thoracic radiotherapy to 66 Gy; (2)concurrent (15 mg/kg) and maintenance (15 mg/kg) bevacizumab during, and following (max 6 cycles, completion of thoracic radiotherapy to 66 Gy;Secondary Objective: 1. Correlate all observed toxicity with dose-volume histograms of irradiated normal organs. 2. Explore surrogate tumor end-points that may correlate with the efficacy of combined treatment with anti-VEGF targeted therapy ;Primary end point(s): To establish the dose of Avastin (bevacizumab) to be administered in phase II trials of radiation and chemo-radiotherapy. | — |
Countries
Netherlands
Outcome results
None listed