EUCTR2010-021382-78-ES
Active, not recruiting
Not Applicable
Dose radiotherapy for lung cancer treatment.
Overview
- Phase
- Not Applicable
- Intervention
- Not specified
- Conditions
- ung cancer.
- Sponsor
- Consorci Mar Parc de Salut de Barcelona (Parc de Salut MAR)
- Status
- Active, not recruiting
- Last Updated
- 14 years ago
Overview
Brief Summary
No summary available.
Investigators
Eligibility Criteria
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.
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.
Outcomes
Primary Outcomes
Not specified
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