Dose radiotherapy for lung cancer treatment.

• Conditions: ung cancer.; Therapeutic area: Diseases [C] - Cancer [C04]

• Registration Number: EUCTR2010-021382-78-ES
• Lead Sponsor: Consorci Mar Parc de Salut de Barcelona (Parc de Salut MAR)

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Study Start: 2010-08-09
• Last Update Posted: 3 April 2012

Recruitment & Eligibility

• Status: Authorised-recruitment may be ongoing or finished
• Sex: All
• Target Recruitment: Not specified

Inclusion Criteria

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

Exclusion Criteria

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.

Study & Design

• Study Type: Interventional clinical trial of medicinal product
• Study Design: Not specified