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Clinical Trials/EUCTR2010-021382-78-ES
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.

Registry
who.int
Start Date
August 9, 2010
End Date
TBD
Last Updated
14 years ago
Study Type
Interventional clinical trial of medicinal product
Sex
All

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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