- ICH GCP
- Registre américain des essais cliniques
- Essai clinique NCT00246181
Phase I and II Study Of Stereotactic Body Radiotherapy in Medically Unresectable Patients With Stage 1 NSCLC (SBF-NSCLC)
Aperçu de l'étude
Statut
Les conditions
Intervention / Traitement
Description détaillée
The most common treatment for early stage lung cancers is to remove the cancer with surgery. Patients with serious underlying health problems like emphysema, diabetes, or heart disease who develop an early stage lung cancer may not be eligible for the standard surgical treatment. The most common alternative to surgery is conventional radiation treatment called fractionated radiotherapy. "Fractionated radiotherapy" means several weeks of treatment with daily radiation sessions. While this treatment is sometimes successful at killing the cancer, it is not as effective as surgery and may significantly damage the surrounding lung tissue.
Newer treatments using radiotherapy have been developed and used for patients with metastases (spreading cancer) to the lungs. Stereotactic radiotherapy uses a frame to guide highly focused beams of radiation at the cancer while avoiding the normal surrounding tissue. Stereotactic radiotherapy also uses a higher daily dose of radiation. The higher daily dose may be more effective than conventional radiotherapy at killing cancer cells and may also decrease side effects.
Type d'étude
Inscription (Réel)
Phase
- Phase 2
- La phase 1
Contacts et emplacements
Lieux d'étude
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Indiana
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Indianapolis, Indiana, États-Unis, 46202
- Indiana University, Department of Radiation Oncology
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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
Inclusion Criteria:
Consistent with most therapeutic oncology trials, patients are not actively "recruited," but are screened by their physician for appropriate clinical trial(s) at the time of their routine clinic visit.
All patients must be willing and capable to provide informed consent to participate in the protocol.
Eligible patients must have appropriate staging studies identifying them as AJCC stage I (T1 or T2, N0, M0) primary lung carcinoma. The patient should not have direct evidence of regional or distant metastases after appropriate staging studies. Histologic confirmation will be required by either biopsy or cytology. The following primary cancer types are eligible: Squamous cell carcinoma, Adenocarcinoma, Large cell carcinoma, bronchioloalveolar cell carcinoma or non-small cell; not otherwise specified.
The primary tumor must be deemed technically resectable by an experienced thoracic cancer clinician, with a reasonable possibility of obtaining a gross total resection with negative margins (defined as a potentially curative resection, PCR); however, the patient should have underlying physiological medical problems that would prohibit a PCR due to a low probability of tolerating general anesthesia, the operation, the post-operative recovery period, or the removal of adjacent functioning lung. Standard "cut-off " guidelines regarding surgical resection of NSCLC include the following: Baseline FEV1 <40%, post-operative predicted FEV1 <30%, severely reduced diffusion capacity, baseline hypoxemia and/or hypercapnia and exercise oxygen consumption <50% predicted.
Patients who refuse a PCR due to preference, ideology, emotional or psychological issues, mental illness, or inability to give consent for the PCR and who have no specific accepted medical contraindications for the PCR are not eligible.
Eligible patients should not have had previous lung or mediastinal radiotherapy.
There must be no plans for the patient to receive other concomitant antineoplastic therapy while on this protocol. Patients who have received chemotherapy within 8 weeks of the start date of study are ineligible.
Patients must be able to fit inside the stereotactic body frame and able to undergo a CT or MRI scan in the frame.
The patient's primary tumor must not be larger than 7.0 cm in greatest dimension.
Patients with active systemic, pulmonary, or pericardial infection are ineligible.
Pregnant or lactating women are ineligible. Women/men of reproductive potential may not participate unless they agreed to use an effective contraceptive method such as condom/diaphragm and spermicidal foam, intrauterine device (IUD), or prescription birth control pills.
Patients must be past their 18th birthday at time of registration. Karnofsky performance status > 60.
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Exclusion Criteria:
See inclusion criteria.
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Plan d'étude
Comment l'étude est-elle conçue ?
Détails de conception
- Objectif principal: Traitement
- Répartition: Non randomisé
- Modèle interventionnel: Affectation à un seul groupe
- Masquage: Aucun (étiquette ouverte)
Que mesure l'étude ?
Principaux critères de jugement
Mesure des résultats |
Délai |
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The purposes of this research study are (1) to find the highest dose of stereotactic radiotherapy that can safely be used for treatment of early stage non-small cell lung cancer.
Délai: 5 years from enrollment completion
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5 years from enrollment completion
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Mesures de résultats secondaires
Mesure des résultats |
Délai |
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(2) to see what effects (good and bad) stereotactic radiotherapy has on patients and their cancer.
Délai: 5 years from completion enrollment
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5 years from completion enrollment
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Collaborateurs et enquêteurs
Parrainer
Collaborateurs
Les enquêteurs
- Chercheur principal: Ronald McGarry, MD, Indiana University - Department of Radiation Oncology
- Chercheur principal: Achilles Fakiris, MD, Indianan University
Publications et liens utiles
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
Termes MeSH pertinents supplémentaires
Autres numéros d'identification d'étude
- 9910-35
Ces informations ont été extraites directement du site Web clinicaltrials.gov sans aucune modification. Si vous avez des demandes de modification, de suppression ou de mise à jour des détails de votre étude, veuillez contacter register@clinicaltrials.gov. Dès qu'un changement est mis en œuvre sur clinicaltrials.gov, il sera également mis à jour automatiquement sur notre site Web .
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