| Titre |
A Randomized Phase II Trial to Assess the Efficacy and Safety of Selective Metabolically Adaptive Radiation Dose Escalation in Locally Advanced Non-Small Cell Lung Cancer Receiving Definitive Chemoradiotherapy |
| Protocole ID |
PET-BOOST |
| ClinicalTrials.gov ID |
NCT02788461 |
| Type(s) de cancer |
Poumon non à petites cellules |
| Phase |
Phase II |
| Stade |
Localement avancé |
| Type étude |
Traitement |
| Institution |
CENTRE UNIVERSITAIRE DE SANTE MCGILL
 SITE GLEN
1001 boul. Décarie , Montréal, QC, H4A 3J1
|
| Ville |
Montréal |
| Investigateur(trice) principal(e) |
Dr Sergio Faria
|
| Coordonnateur(trice) |
Marianna Perna
514-934-1934 poste 43191
|
| Statut |
 Actif en recrutement |
| Critètes d'éligibilité |
- Patients who are at least 18 years old and are able to consent
- Patients who will undergo Chemo-RT as primarily modality of treatment
- Patients with a primary tumor or node measuring at least 10mm on CT scan
- Patients with a PET avid tumor having Standardized Uptake Values (SUV) > 4
- Patients with Eastern Cooperative Oncology Group (ECOG) status 0-2 within 4 weeks of randomization
|
| Critètes d'exclusion |
- Trimodality patients who have surgery as part of curative treatment
- Previous radiotherapy to intended treatment volumes
- Active invasive malignancy other than lung cancer
- Active pregnancy
- Poor respiratory function (Forced Expiratory Volume < 1.0 or Diffusing Capacity < 50% age-adjusted normal)
- ECOG status > 2
- Pre-treatment complete blood count/differential showing inadequate bone marrow reserve (absolute neutrophil count < 1800 cells/mm3 or platelets < 100 000 cells/mm3 or hemoglobin < 90g/L), measured within 4 weeks of registration
- AST, ALT or total bilirubin > 2.5 times the upper limit of normal, measured within 4 weeks of registration
- Unintentional weight loss >10% over 3 months within 4 weeks of registration
- Severe active co-morbidity defined by:
- Significant history of uncontrolled cardiac disease; i.e. uncontrolled hypertension, unstable angina, myocardial infarction within the last 6 months, uncontrolled congestive heart failure, cardiomyopathy with decreased ejection fraction
- Transmural myocardial infection requiring intravenous antibiotics at the time of registration
- Chronic Obstructive Pulmonary Disease exacerbation or other respiratory illness requiring hospitalization or precluding study therapy within 30 days before randomization
- Acquired immune deficiency syndrome (AIDS) based on the current Centre for Disease Control definition; note, however, that HIV testing is not required for entry into this protocol
|
Groupe d'étude en oncologie du Québec