NSCLC stage III or inoperable stage II MedDRA version: 14.1 Level: PT Classification code 10062041 Term: Lung infiltration malignant System Organ Class: 10029104 - Neoplasms benign, malignant and unspecified (incl cysts and polyps) MedDRA version: 14.1 Level: PT Classification code 10023779 Term: Large cell lung cancer stage III System Organ Class: 10029104 - Neoplasms benign, malignant and unspecified (incl cysts and polyps) MedDRA version: 14.1 Level: PT Classification code 10025036 Term: L
Conditions
Sponsors
NKI-AVL
Eligibility
Sex/Gender
All
Inclusion criteria
Inclusion criteria: • Cytological or histological proven NSCLC stage III or inoperable stage II, cT1-2a-3N1-3M0 with peripheral tumors 40 % of the age-adjusted normal value o Adequate bone marrow reserve: absolute neutrophil (segmented and bands) count (ANC) =1.5 x 109/L, platelets = 100 x 109/L, and hemoglobin = 5.5 mmol/L. o Hepatic: bilirubin = 1.5 times the upper limit of normal (× ULN); alkaline phosphatase (AP), aspartate aminotransferase (ASAT), and alanine aminotransferase (ALAT) = 3.0 × ULN. o Renal: calculated creatinine clearance (CrCl) = 45 ml/min based on the original weight based Cockcroft and Gault formula. • Before patient registration, written informed consent must be given according to GCP and national regulations 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 5 F.1.3 Elderly (>=65 years) yes F.1.3.1 Number of subjects for this age range 10
Exclusion criteria
Exclusion criteria: • Patients with central tumors < 2 cm of the proximal bronchial tree (Figure 2) or tumors immediately adjacent to mediastinal or pericardial pleura. • Patients that receive sequential chemoradiotherapy or radiotherapy only. • Patients with grade 3 dyspnea at baseline (according to CTCAE version 4.03) • Patients with Pancoast tumors • Pregnant women
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Main Objective: To define the recommended phase II mean-lung dose (MLD) to treat peripheral stage II or III non small cell lung cancer (NSCLC) using stereotactic ablative radiotherapy (SABR) for the primary tumor and conventional fractionated radiotherapy (CFRT) for the mediastinal lymph nodes while given concurrent chemotherapy;Secondary Objective: • To describe toxic effects of the Hybrid treatment • To assess the overall treatment time • Evaluation of local control • Evaluation of regional control • Evaluation of overall survival • Evaluation of local effect on normal tissue changes ;Primary end point(s): The mean-lung dose that is associated with a 15 % probability of dose limiting toxicity, defined according to the CTCAE v4.03; radiation pneumonitis = grade 3 and radiation induced dyspnea = grade 3. ;Timepoint(s) of evaluation of this end point: 1 year | — |
Secondary
| Measure | Time frame |
|---|---|
| Timepoint(s) of evaluation of this end point: 1) 1 year 2-6) 2 years;Secondary end point(s): 1) To describe toxic effects of the Hybrid treatment 2) To assess the overall treatment time 3) Evaluation of local control 4) Evaluation of regional control 5) Evaluation of overall survival 6) Evaluation of local effect on normal tissue changes | — |
Countries
Netherlands
Contacts
Public ContactPrincipal Investigator
NKI-AVL
Outcome results
None listed