Lung cancer.
Conditions
Interventions
Product Name: f18-Fluormisonidazol (FMISO)
Pharmaceutical Form: Solution for injection
INN or Proposed INN: No aplica
CAS Number: 150196-34-2
Current Sponsor code: [18F]-FMISO
Other descriptive name:
Sponsors
Consorci Mar Parc de Salut de Barcelona (Parc de Salut MAR)
Eligibility
Sex/Gender
All
Inclusion 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 =65 years) no F.1.3.1 Number of subjects for this age range
Exclusion criteria
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.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Main Objective: Phase I: To determine the maximal tolerated dose (MTD) of radiotherapy in lung cancer patients, who are candidates to radical treatment with chemotherapy or radiotherapy. Doses will be increased according to hypoxic regions of the tumor measured by FMISO-PET. Phase II: To determine the clinical efficacy of the MTD in a group of 30 lung cancer patients evaluating tumoral response rate.;Secondary Objective: To determine local disease free survival, distance disease free survival, and acute and chronic toxicity.;Primary end point(s): -Maximal tolerated dose (MTD) evaluation: acute toxicity will be collected (? 90 days after radiotherapy) following the grades of the NCI CTC (Commom Toxicity Criteria) version 3.0. Late effects (collected > 90 days after radiotherapy) will be collected following the RTOG Late Radiation Morbidity Scoring Scale. The adverse vents directly attributed to radiotherapy will be collected following the NCI CTCv3.0. - Efficacy evaluation: complete or partial remissions;Timepoint(s) of evaluation of this end point: In both, Phase I and Phase II, subjects will be evaluated at least once per week during therapy, collecting acute toxicity. After that, evaluations will be done monthly and then every three months to complete one year. In the Phase II part, the response variable will be obtained by a CT (one month aftter therapy). | — |
Secondary
| Measure | Time frame |
|---|---|
| Secondary end point(s): Efficacy evaluated in terms of global survival, local disease free survival, distance disease free survival. In addition acute and chronic toxicity.;Timepoint(s) of evaluation of this end point: In both, Phase I and Phase II, subjects will be evaluated at least once per week during therapy, collecting acute toxicity. After that, evaluations will be done monthly and then every three months to complete one year. | — |
Countries
Spain
Contacts
Public ContactServicio de Oncología Radioterápica
Hospital de l'Esperança
Outcome results
None listed