Positron Emission Tomography Pre- and Post-treatment Assessment For Locally Advanced Non-Small Cell Lung Carcinoma
Collecte de données
Néoplasmes pulmonaires+4
+ Maladies pulmonaires
+ Néoplasmes par site
Étude diagnostique
Résumé
Date de début de l'étude : 1 mars 2005
Date à laquelle le premier participant a commencé l'étude.OBJECTIVES: Primary * Determine whether peak standardized uptake value (SUV) for fludeoxyglucose F 18 positron emission tomography (FDG-PET) shortly after definitive chemoradiotherapy is predictive of long-term survival of patients with inoperable stage IIB or III non-small cell lung cancer. Secondary * Determine whether max SUV for FDG-PET shortly after definitive chemoradiotherapy is predictive of long-term survival in these patients. * Determine whether post-treatment imaging using peak and max SUV for FDG-PET shortly after definitive chemoradiotherapy is predictive of local disease control in these patients. * Determine whether pre-treatment imaging using these techniques is predictive of long-term survival and local disease control in these patients. * Correlate, if possible, Ki-67 expression with overall survival of patients assessed with these imaging techniques. OUTLINE: This is a diagnostic, multicenter study. Before starting chemoradiotherapy, patients undergo baseline whole-body positron emission tomography (PET) imaging. Patients receive fludeoxyglucose F 18 (\^18FDG) IV followed 50-70 minutes later by PET imaging. Patients then receive concurrent definitive radiotherapy and chemotherapy. Patients enrolled in other treatment-oriented clinical trials receive therapy as per that trial. Other patients receive standard thoracic radiotherapy (dose ≥ 60 Gy) and standard chemotherapy comprising a platin (cisplatin or carboplatin) and a second non-platin, non-gemcitabine drug (etoposide, vinblastine, vinorelbine, paclitaxel, or docetaxel). Approximately 14 weeks after completion of chemoradiotherapy and adjuvant chemotherapy (if given), patients undergo post-treatment \^18FDG-PET imaging. Patients are followed every 3 months for 2 years and then every 6 months for at least 1 year. PROJECTED ACCRUAL: A total of 250 patients (including at least 75 with stage IIB/IIIA disease and at least 75 with stage IIIB disease) will be accrued for this study within 2 years.
Protocole
Cette section fournit des détails sur le plan de l'étude, y compris la manière dont l'étude est conçue et ce qu'elle évalue.250 participants à inclure
Nombre total de participants que l'essai clinique vise à recruter.Diagnostic
Éligibilité
Les chercheurs recherchent des patients correspondant à une certaine description appelée critères d'éligibilité : état de santé général ou traitements antérieurs du patient.Tout sexe
Le sexe biologique des participants éligibles à s'inscrire.À partir de 18 ans
Tranche d'âge des participants éligibles à participer.Volontaires sains non autorisés
Indique si les individus en bonne santé et ne présentant pas la condition étudiée peuvent participer.Conditions
Pathologie
Critères
DISEASE CHARACTERISTICS: * Histologically confirmed non-small cell lung cancer (NSCLC) * Clinical stage IIB or III disease * No small cell carcinoma * No stage IV disease\* * No diffuse bronchoalveolar subtype * No planned definitive surgical resection NOTE: \*Patients with evidence of stage IV disease by positron emission tomography are eligible if the evidence cannot be confirmed by other means AND the physician still plans to proceed with definitive chemoradiation * Planning treatment with definitive chemoradiotherapy * May be treated on another Radiation Therapy Oncology Group protocol (except phase I studies) OR with conventional concurrent NSCLC chemoradiotherapy * Radiotherapy ≥ 60 Gy AND chemotherapy to include concurrent platinum-based therapy * No brain metastases by head CT scan or MRI PATIENT CHARACTERISTICS: Age * 18 and over Performance status * Zubrod 0-1 Life expectancy * Not specified Hematopoietic * Not specified Hepatic * Not specified Renal * Not specified Other * Medically suitable for early concurrent chemoradiotherapy (radiotherapy dose ≥ 60 Gy) * Able to tolerate positron emission tomography imaging * No poorly controlled diabetes (defined as fasting glucose level \> 200 mg/dL) * No other malignancy within the past 3 years except basal cell or squamous cell skin cancer or carcinoma in situ * Not pregnant or nursing * Negative pregnancy test * Fertile patients must use effective contraception during and for 3 months after study participation PRIOR CONCURRENT THERAPY: Biologic therapy * No anticipated use of adjuvant biologic therapy beyond 14 weeks after the completion of radiotherapy Chemotherapy * See Disease Characteristics * No anticipated use of adjuvant chemotherapy beyond 14 weeks after the completion of radiotherapy Endocrine therapy * Not specified Radiotherapy * See Disease Characteristics * No prior thoracic radiotherapy * No concurrent intensity-modulated radiotherapy Surgery * See Disease Characteristics
Plan de l'étude
Découvrez tous les traitements administrés dans cette étude, leur description détaillée et ce qu'ils impliquent.Objectifs de l'étude
Objectifs principaux
Objectifs secondaires
Centres d'étude
Ce sont les hôpitaux, cliniques ou centres de recherche où l'essai est conduit. Vous pouvez trouver le site le plus proche de vous ainsi que son statut.Cette étude comporte 49 sites
Lurleen Wallace Comprehensive Cancer at University of Alabama - Birmingham
Birmingham, United StatesVoir le siteScottsdale Medical Imaging, Limited
Scottsdale, United StatesUSC/Norris Comprehensive Cancer Center and Hospital
Los Angeles, United StatesRadiological Associates of Sacramento Medical Group at Sutter Cancer Center
Sacramento, United States