stage III locally advanced non small cell lung cancer (LA-NSCLC) MedDRA version: 8.1 Level: LLT Classification code 10029519 Term: Non-small cell lung cancer stage III
Conditions
Interventions
Trade Name: Taxotere
Product Name: Docetaxel
Pharmaceutical Form: Intravenous infusion
Trade Name: Cisplatin
Product Name: cis-diamminedichloroplatinum
Pharmaceutical Form: Intravenous infusion
Sponsors
AZ-VUB
Eligibility
Sex/Gender
All
Inclusion criteria
Inclusion criteria: Informed consent (A4) is required. Histologically or cytologically confirmed NSCLC (adenocarcinoma, squamous cell carcinoma, large cell carcinoma or a combination of these) Patients must have a stage III unresectable LA-NSCLC: Males or females aged between 18 and 75 years. Life expectancy of at least 12 weeks. ECOG performance status 0,1 or2. Weight loss = 10% within the last 3 months. Laboratory requirements at entry: Blood cell counts: i. Absolute neutrophils = 2.0 x 109/L ii. Platelets = 100 x 109/L iii. Haemoglobin = 11 g/dl Renal function: iv. Serum creatinine 60 ml/min. Hepatic function: vi. Serum bilirubin 1.5 x UNL associated with alkaline phosphatase> 2.5 x UNL is not eligible for the study. Lung function tests at entry: • FEV1: = 50 % x Normal value • DLCO: = 50 % x Normal value Adequate cardiac function. Patient with either measurable and/or non-measurable lesion (according to RECIST criteria, A1). 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: Diagnosis of small cell lung cancer. Stage IIIB NSCLC, based on the presence of malignant pleural or pericardial effusion. Pregnant or lactating women. Patients (male or female) with reproductive potential not implementing adequate contraceptive measures. Prior systemic chemotherapy, immunotherapy, or biological therapy including neoadjuvant or adjuvant treatment for NSCLC. Prior surgery for NSCLC, if less than 5 years from study. Prior radiotherapy for NSCLC. History of prior malignancy, except for cured non-melanoma skin cancer, curatively treated in-situ carcinoma of the cervix or other cancer curatively treated and with no evidence of disease for at least five years. Symptomatic peripheral neuropathy Grade = 2 except if due to trauma. Other serious concomitant illness or medical conditions: Congestive heart failure or angina pectoris except if it is medically controlled. Previous history of myocardial infarction within 1 year from study entry, uncontrolled hypertension or arrhythmias. History of significant neurological or psychiatric disorders including dementia or seizures. Active infection requiring IV antibiotics. Active ulcer, unstable diabetes mellitus or other contra-indication to corticosteroid therapy. Superior vena cava syndrome contra-indicating hydration. Pre-existing pericardial effusion. Pre-existing symptomatic pleural effusion. Significant gastrointestinal abnormalities, including requirement for intravenous nutrition, active peptic ulcer disease, prior surgical procedures affecting absorption. Distant metastasis. Concurrent treatment with any other experimental anti-cancer drugs. Concomitant or within 4-week period administration of any other experimental drug under investigation. Significant ophthalmologic abnormalities. Moderate to severe dermatitis. Hypersensitivity to docetaxel, cisplatin, or any of its excipients. Concomitant use of phenytoin, carbamazepin, barbiturates, or rifampicin. Mental condition rendering the patient unable to understand the nature, scope, and possible consequences of the study. Patient unlikely to comply with protocol, i.e., uncooperative attitude, inability to return for follow-up visits, and not likely to complete the study.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Main Objective: To evaluate the feasibility and toxicity of radiation dose escalation using helical tomotherapy concurrently with chemotherapy (docetaxel-cisplatin combination) in stage III locally advanced non small cell lung cancer (LA-NSCLC).;Secondary Objective: To estimate efficacy parameters in terms of overall response rate, progression free survival and overall survival. To monitor quality of life (QOL) before, during and after treatment. ;Primary end point(s): At least 5 patients will be tested at each dose level. Initially, 5 evaluable patients are to be treated at the first dose level. If no episodes of dose limiting toxicity (DLT) are recorded within 3 months from start of therapy the dose is escalated to the next level. This strategy (0/5) provides at least 97% confidence of a true DLT rate of less than 50%. Taking into account a predicted base-line toxicity of 20%-30% (data not provided, but based on an analysis of dose escalation trials using a concurrent radiochemotherapy with docetaxel) a maximum of 50% seems reasonable in a radiation dose escalation trial. In case of one patient with DLT, however an additional cohort of 5 patients should be accrued. One additional patient with DLT provides a 95% confidence of a DLT rate of less than 50% (no more than 2/10) and dose escalation can proceed. In case of three or more the dose should be regarded as to toxic and further dose escalation should be aborted. An additional cohort of 5 patients will allow us to safely predict the maximum tolerated dose (MTD). | — |
Countries
Belgium
Outcome results
None listed