Evaluation of the rate of pathological complete response rate (pCR) for neoadjuvant chemoradiotherapy (CT-RT) and for chemotherapy (CT) alone in locally advanced non small cell lung cancer (LA-NSCLC): a randomised phase II trial
- Conditions
- ocally advanced non small cell lung cancer
- Registration Number
- EUCTR2005-005139-84-CZ
- Lead Sponsor
- PIERRE FABRE MEDICAMENT
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- ot Recruiting
- Sex
- All
- Target Recruitment
- 200
- Patients aged between 18 and 75 years
- Histologically or cytologically (fine needle aspiration) proven non-small cell lung cancer (NSCLC)
- Untreated locally advanced inoperable stage IIIA (only pN2 confirmed by mediastinoscopy)
- Patients with a Karnofsky Performance Status ³ 80%
- Adequate pulmonary function
- Life expectancy > 12 weeks
- Patients without weight loss > 10% within the previous 3 months
- Adequate bone marrow, hepatic and renal functions (Neutrophils ³ 2.0 x 109/L-Platelets ³ 100 x 109/L, Haemoglobin ³ 12 g/dL, Total bilirubin £ 1.5 x ULN, Transaminases £ 2.5 x ULN, Alkaline phosphatase < 5 x ULN, Glomerular Filtration Rate ³ 65 mL/min per 1.73 m2·
- Presence of at least one measurable lesion (RECIST)
- Absence of any psychological, familial, sociological or geographical conditions potentially hampering compliance with the study protocol
- Absence of current or recent (within 2 weeks before registration) severe infection
- Absence of renal or hearing impairment
- Women of childbearing potential must be using a medically accepted method of contraception (i.e. oral contraceptives, intrauterine devices) to avoid pregnancy during the 2 months preceding the start of study treatment, throughout the study period and for up to 3 months after the last dose of study treatment in such a manner that the risk of pregnancy is minimised. Women of childbearing potential must have a negative serum or urine pregnancy test within 72 hours prior to the start of study treatment
- Fertile men must be using an effective method of birth control if their partners are women of childbearing potential
- Patients who give written (personally signed and dated) inform consent before completing any study-related procedure.
Are the trial subjects under 18? no
Number of subjects for this age range:
F.1.2 Adults (18-64 years)
F.1.2.1 Number of subjects for this age range
F.1.3 Elderly (>=65 years)
F.1.3.1 Number of subjects for this age range
- Patients with NSCLC stages I, II, bulky IIIA (except pN2 confirmed by mediastinoscopy), IIIB and IV
- With tumour extent or location precluding radical radiotherapy as specified in the protocol
-Symptomatic neuropathy (sensory) > grade 1 according to the NCI Common Toxicity Criteria
- Hearing impairment ³ Grade 2
- Concomitant/uncontrolled medical disorder (cardiac failure or myocardial infarction within the previous 3 months; uncontrolled hypertension or arrhythmia; uncontrolled hypercalcaemia; active infection requiring I.V. antibiotics within 2 weeks before the beginning of treatment)
- Weight loss > 10% within the previous 3 months
- Pre-existing malignant pleural effusion
- Ascites or pericardial effusion
- Active secondary malignancy except appropriately treated carcinoma in situ of the cervix or skin basal cell cancer. Patients with a history of cancer and at least five years of uneventful follow up and no signs of recurrence may be eligible.
- Previous or concomitant treatment with other anticancer drugs during the last 5 years
- Known hypersensitivity to the study drugs or to drugs with similar chemical structures
- Concomitant treatment with systemic corticosteroids except chronic treatment lasting more than 1 month at low doses (£ 20 mg/day of methyl prednisolone or equivalent)
- Significant malabsorption syndrome or disease affecting the gastrointestinal tract function and the absorption of oral drugs
- Women if pregnant or breast-feeding or with Positive pregnancy test at inclusion
- Male or female of childbearing potential who is unwilling or unable to use a medically accepted method to avoid pregnancy during the 2 months preceding the start of study treatment, throughout the study period and at least 3 months following the last dose of study treatment
- Participation to another clinical trial with any investigational drug study (whatever the use, curative, prophylactic or diagnostic intent) within 30 days prior to registration.
Study & Design
- Study Type
- Interventional clinical trial of medicinal product
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method Main Objective: To estimate the effect of CT-RT on pCR in resectable patients;Secondary Objective: - To estimate the effect of CT alone on pCR in marginally resectable patients<br>- To evaluate the clinical OR rate of complete surgery (R0 rate), event free survival and overall survival<br>- To assess tolerance ;Primary end point(s): Pathological complete response rate (pCR)
- Secondary Outcome Measures
Name Time Method