Radiation Therapy in Treating Patients With Stage I Non-Small Cell Lung Cancer And Lung Dysfunction
Accelerated Conformal Radiotherapy for Stage I Non-Small Cell Lung Cancer in Patients With Pulmonary Dysfunction: A Phase I Study
RATIONALE: Specialized radiation therapy that delivers a high dose of radiation directly to the tumor may kill more tumor cells and cause less damage to normal tissue.
PURPOSE: Phase I trial to study the effectiveness of specialized high-dose radiation therapy in treating patients who have stage I non-small cell lung cancer and lung dysfunction.
Aperçu de l'étude
Statut
Les conditions
Intervention / Traitement
Description détaillée
OBJECTIVES:
- Determine the maximum tolerated course of accelerated 3-dimensional conformal radiotherapy in patients with stage I non-small cell lung cancer with pulmonary dysfunction.
- Determine the short-term and long-term toxicity of this regimen in these patients.
- Determine local tumor control, failure-free survival, and overall survival in patients treated with this regimen.
- Determine the effect of radiotherapy dose volume relationships and pre-treatment pulmonary function studies on the incidence of pulmonary toxicity in these patients.
OUTLINE: This is a dose-escalation, multicenter study.
Patients receive accelerated 3-dimensional (3-D) conformal radiotherapy daily 5 days a week for 3.5-6 weeks.
Cohorts of 8 patients receive escalating fractions of accelerated 3-D conformal radiotherapy until the maximum tolerated course is determined. The maximum tolerated course is defined as the course at which no more than 2 patients develop at least grade 3 dose-limiting toxicity and no more than 1 patient develops at least grade 4 dose-limiting toxicity.
Patients are followed at 3 weeks, 6 weeks, 3 months, every 3 months for 2 years, and then every 6 months for 3 years.
Type d'étude
Inscription (Réel)
Phase
- La phase 1
Contacts et emplacements
Lieux d'étude
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Florida
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Fort Lauderdale, Florida, États-Unis, 33308
- Michael & Dianne Bienes Comprehensive Cancer Center at Holy Cross Hospital
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Hollywood, Florida, États-Unis, 33021
- Memorial Cancer Institute at Memorial Regional Hospital
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Jupiter, Florida, États-Unis, 33458
- Ella Milbank Foshay Cancer Center at Jupiter Medical Center
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Miami Beach, Florida, États-Unis, 33140
- CCOP - Mount Sinai Medical Center
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Illinois
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Chicago, Illinois, États-Unis, 60637-1470
- University of Chicago Cancer Research Center
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Minnesota
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Minneapolis, Minnesota, États-Unis, 55455
- Fairview University Medical Center - University Campus
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Missouri
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Chesterfield, Missouri, États-Unis, 63017
- Saint Luke's Hospital
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Nebraska
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Grand Island, Nebraska, États-Unis, 68803
- Saint Francis Cancer Treatment Center at Saint Francis Memorial Health Center
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North Platte, Nebraska, États-Unis, 69103
- Great Plains Regional Medical Center
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Omaha, Nebraska, États-Unis, 68198
- UNMC Eppley Cancer Center at the University of Nebraska Medical Center
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New York
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Buffalo, New York, États-Unis, 14215
- Veterans Affairs Medical Center - Buffalo
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Oswego, New York, États-Unis, 13126
- Oswego Hospital
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Syracuse, New York, États-Unis, 13210
- SUNY Upstate Medical University Hospital
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Syracuse, New York, États-Unis, 13057
- CCOP - Syracuse Hematology-Oncology Associates of Central New York, P.C.
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Syracuse, New York, États-Unis, 13203
- St. Joseph's Hospital Health Center - Syracuse
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North Carolina
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Charlotte, North Carolina, États-Unis, 28203
- Blumenthal Cancer Center at Carolinas Medical Center
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Goldsboro, North Carolina, États-Unis, 27534
- Wayne Memorial Hospital, Incorporated
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Winston-Salem, North Carolina, États-Unis, 27157
- Comprehensive Cancer Center at Wake Forest University
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Ohio
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Columbus, Ohio, États-Unis, 43210
- Arthur G. James Cancer Hospital and Solove Research Institute at Ohio State University
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Pennsylvania
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Pittsburgh, Pennsylvania, États-Unis, 15224-1791
- Western Pennsylvania Cancer Institute at Western Pennsylvania Hospital
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Critères de participation
Critère d'éligibilité
Âges éligibles pour étudier
Accepte les volontaires sains
Sexes éligibles pour l'étude
La description
DISEASE CHARACTERISTICS:
Histologically or cytologically confirmed stage I (T1-2, N0) non-small cell lung cancer (NSCLC)
- Squamous cell carcinoma
- Basaloid carcinoma
- Adenocarcinoma
- Bronchoalveolar carcinoma
- Adenosquamous carcinoma
- Large cell carcinoma
- Large cell neuroendocrine carcinoma
- Giant cell carcinoma
- Sarcomatoid carcinoma
- Non-small cell carcinoma not otherwise specified
- Tridimensionally measurable solitary parenchymal lung lesion no greater than 4 cm in diameter by chest CT scan (lung windows)
No metastatic disease or hilar or mediastinal lymphadenopathy
Must have mediastinoscopy* (anterior, cervical, or both) if mediastinal lymph nodes are greater than 1.0 cm in diameter by chest CT scan
- No positive lymph nodes on mediastinoscopy* NOTE: *Patients may have positron-emission tomography in lieu of mediastinoscopy provided there is no fludeoxyglucose F 18 uptake in the mediastinum and hilum
Poor surgical risk, as defined by 1 of the following:
- High risk due to nonpulmonary reasons, such as renal failure, cardiac failure, or hepatic dysfunction and deemed by thoracic surgeon to be unsuitable for lobectomy
Pulmonary dysfunction indicated by one or more of the following:
- FEV_1 less than 40% of predicted
- DLCO less than 50% of predicted
- Oxygen dependent
- Chronic PaCO_2 greater than 45 mm Hg
- VO_2 less than 15 mL/kg/min
PATIENT CHARACTERISTICS:
Age:
- 18 and over
Performance status:
- 0-2
Other:
- Not pregnant or nursing
- Fertile patients must use effective contraception
- No weight loss of more than 10% within the past 6 months
- No other active (less than 30% risk of relapse after completion of prior therapy) malignancy except nonmelanoma skin cancer
Chemotherapy:
- No prior chemotherapy for NSCLC
Radiotherapy:
- No prior chest radiotherapy
Plan d'étude
Comment l'étude est-elle conçue ?
Détails de conception
- Objectif principal: Traitement
- Répartition: N / A
- Modèle interventionnel: Affectation à un seul groupe
- Masquage: Aucun (étiquette ouverte)
Armes et Interventions
Groupe de participants / Bras |
Intervention / Traitement |
|---|---|
|
Expérimental: Radiotherapy
Patients receive accelerated 3-dimensional (3-D) conformal radiotherapy daily 5 days a week for 3.5-6 weeks. Cohorts of 8 patients receive escalating fractions of accelerated 3-D conformal radiotherapy until the maximum tolerated course is determined. The maximum tolerated course is defined as the course at which no more than 2 patients develop at least grade 3 dose-limiting toxicity and no more than 1 patient develops at least grade 4 dose-limiting toxicity. Patients are followed at 3 weeks, 6 weeks, 3 months, every 3 months for 2 years, and then every 6 months for 3 years. |
Que mesure l'étude ?
Principaux critères de jugement
Mesure des résultats |
Délai |
|---|---|
|
La survie globale
Délai: Jusqu'à 5 ans
|
Jusqu'à 5 ans
|
|
Survie sans échec
Délai: Jusqu'à 5 ans
|
Jusqu'à 5 ans
|
Collaborateurs et enquêteurs
Parrainer
Collaborateurs
Les enquêteurs
- Chaise d'étude: Jeffrey Bogart, MD, State University of New York - Upstate Medical University
Publications et liens utiles
Dates d'enregistrement des études
Dates principales de l'étude
Début de l'étude
Achèvement primaire (Réel)
Achèvement de l'étude (Réel)
Dates d'inscription aux études
Première soumission
Première soumission répondant aux critères de contrôle qualité
Première publication (Estimation)
Mises à jour des dossiers d'étude
Dernière mise à jour publiée (Estimation)
Dernière mise à jour soumise répondant aux critères de contrôle qualité
Dernière vérification
Plus d'information
Termes liés à cette étude
Mots clés
Termes MeSH pertinents supplémentaires
Autres numéros d'identification d'étude
- CALGB-39904
- U10CA076001 (Subvention/contrat des NIH des États-Unis)
- CDR0000068409 (Identificateur de registre: NCI Physician Data Query)
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