Cetuximab, non-small lung carcinoma, cisplation, radiotherapy, locally advanced
Conditions
Interventions
Addition of Cetuximab to standard concurrent chemoradiotherapy (CCRT). Standard CCRT consists of Daily dosing of Cisplatin (6mg/m2) and radiotherapy (2.75Gy) during 24 consecutive days excluding the w
Sponsors
NKI-AVL
Eligibility
Inclusion criteria
Inclusion criteria: 1. >= 18 years of age; 2. Histologically or cytologically confirmed diagnosis of NSCLC; 3. Stage II/III non-operable disease, without malignant pleural effusion; 4. Presence of at least one measurable target lesion; 5. Acceptable pulmonary function as defined by a Fev1 of >=30% and a DLCO of > 40% of predicted; 6. WHO performance 0-1; 7. Life expectancy of at least 6 months; 8. Adequate haematological, renal and hepatic functions: A. Absolute neutrophil count > 2x109/l; B. Platelet count > 100 x 109/l; C. Total bilirubin 50 ml/min; measured or calculated; G. Urine dipstick for proteinuria = 2 (CTC); 10. Patients of reproductive potential must agree to practice an effective medically approved contraceptive method during the trial and 3 months afterwards; 11. Expected risk of radiation-induced pulmonary toxicity is not high: V20 =< 36% / MLD =< 20%; 12. Signed written informed consent.
Exclusion criteria
Exclusion criteria: 1. Concurrent active malignancy other than localized, non-melanoma skin cancer or carcinoma-in-situ of the cervix (unless definitive treatment was completed 5 years or more before study entry and the patient has remained disease free); 2. Prior: A. Ipsilateral radiotherapy to the chest; B. Chemotherapy within the last 5 years; C. Immunotherapy or treatment with murine monoclonal antibodies, Cetuximab, or other EGFR inhibitors. 3. Pregnant or breast-feeding patients; 4. WHO performance score > 1; 5. Other serious diseases, such as heart failure, angina pectoris, myocardial infarction within the last 6 months, uncontrolled hypertension; 6. 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; 7. Participation in other trial with investigational drug or treatment modality.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| The clinical activity of Cetuximab CCRT locally advanced NSCLC (as defined by the objective rate of local control (OLRC)). | — |
Secondary
| Measure | Time frame |
|---|---|
| 1. The safety profile of Cetuximab in combination with concurrent chemo-radiotherapy; 2. Overall survival (OS); 3. Progression free survival (locoregional/distant) (PFS); 4. Duration of overall response; 5. Response duration; 6. Adverse events. | — |
Contacts
Public ContactM.M. Heuvel, van den
Stichting Het Nederlands Kanker Instituut - Antoni van Leeuwenhoek Ziekenhuis Plesmanlaan 121
Outcome results
None listed