Dose radiotherapy for lung cancer treatment.

Consorci Mar Parc de Salut de Barcelona (Parc de Salut MAR)0 个研究点开始时间: 2010年8月9日最近更新: 2012年4月3日

适应症

试验速览

暂无简介。

•a) Men or women who are between 18 and 65 years of age
•b)Subjects with histologically or cytologically confirmed non-small cell carcinoma
•c)Stage III
•d)Karnofsky index = 70 %.
•e)Forced Expiratory Volume in 1 second (FEV1) equal or greater than 1 Liter.
•f)Measurable disease on CT scan of radiotherapy planning.
•g)Lung percentage (both lungs excluding PTV or planned volume) that will recive a dose > 20 Gy (V20 ) must be less or equal of 30 %.
•h)The esophagus volume vill be delimited withoth excluding PTV. The percentage of esophagus that will recive a dose > 60 Gy (V60) mus be less or equal to 30% and the mean dose in esophagus (MED) less or equal to 34 Gy.
•i) Concomitanr chemotherapy.
•j) Biochemistry and blood analysis. Neutrophils = 1500/µl; platelets = 100000/µl; creatinine = 2 mg/dl, hepatic transaminases < 2,5 times the upper limit of normality, bilirubin < 1,5 times upper limit of normality; alkaline phosphatase < 2,5 times the upper limit of normality.
•k) Women must commit to consistent and correct use of an acceptable method of birth control.
•l) Subject with a weigth loss <10% in the previous three months of the disgnosis.
•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 42
•F.1.3 Elderly (>=65 years) no
•F.1.3.1 Number of subjects for this age range

•a)Small-cell carcinoma
•b)Pleural or pericardic effusion with positive cytology
•c)Supraclavicular adenopathy positive
•d)Superior vena cava syndrome
•e)Previous thoracic radiation.
•f)Sensitive neuropathy > grade I following NCI CTCv 3.0 criteria
•g)Severe comorbididy (acute myocardial infacrtion within 3 nmonth of inclusion, cardiac arrithmia or non-controlled hypertension )
•h)Treatments that can interfere with the pharmacokinetic or pharmacodynamic of (18F)-FMISO.
•i)Pregnant or breast-feeding females
•j)Subjects older than 65 years.
•k)Subjects with renal and/or hepatic function impairment or failure. A renal impairment is considered if serum creatinine = 2 mg/dl and an hepatic impairment is diagnosed if bilirubin = 1,5 times upper limit normal and or tranbaamionas (ASAT-ALAT) = 2,5 times the upper limit of normality.

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