Evaluation of the rate of pathological complete response for neoadjuvant chemoradiotherapy and for chemotherapy alone in locally advanced lung cancer.
- Conditions
- ocally advanced non small cell lung cancerTherapeutic area: Diseases [C] - Cancer [C04]
- Registration Number
- EUCTR2005-005139-84-ES
- Lead Sponsor
- PIERRE FABRE MEDICAMENT
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- ot Recruiting
- Sex
- Not specified
- 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 ? 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 > 2.0 x 109/lL
-Platelets > 100 x 109/lL
-Haemoglobin > 12 g/dldL
-Total Bilirubin bilirubin < 1.5 x ULN
-Transaminases < 2.5 x ULN
-Alkaline phosphatase < 5 x ULN
-Glomerular Filtration Rate < 65 mlmL/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) yes
F.1.2.1 Number of subjects for this age range 160
F.1.3 Elderly (>=65 years) yes
F.1.3.1 Number of subjects for this age range 160
? 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 ? 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;<br> 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<br> ;Primary end point(s): Pathologic complete response rate (pCR);Timepoint(s) of evaluation of this end point: Surgery will be performed between 3 and 6 weeks after the end of either CT-RT or CT alone. In these patients, pathological examination will be performed in order to establish the pCR rate.
- Secondary Outcome Measures
Name Time Method <br> Secondary end point(s): 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<br> ;Timepoint(s) of evaluation of this end point: Follow-up will continue until death.