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Sponsors and Collaborators: |
American College of Radiology Imaging Network National Cancer Institute (NCI) Radiation Therapy Oncology Group |
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Information provided by: | National Cancer Institute (NCI) |
ClinicalTrials.gov Identifier: | NCT00083083 |
RATIONALE: Imaging procedures, such as fludeoxyglucose F18 positron emission tomography (^18FDG-PET), may improve the ability to detect disease progression and help doctors predict a patient's response to treatment and plan more effective treatment.
PURPOSE: This phase II trial is studying how well ^18FDG-PET imaging works in detecting disease progression and determining response to treatment in patients who are undergoing chemoradiotherapy for locally advanced non-small cell lung cancer.
Condition | Intervention | Phase |
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Lung Cancer |
Drug: carboplatin Drug: cisplatin Drug: docetaxel Drug: etoposide Drug: fludeoxyglucose F 18 Drug: paclitaxel Drug: vinblastine Drug: vinorelbine ditartrate Procedure: gene expression analysis Procedure: positron emission tomography Procedure: radiation therapy |
Phase II |
Study Type: | Interventional |
Study Design: | Diagnostic, Open Label |
Official Title: | Positron Emission Tomography Pre- and Post-Treatment Assessment For Locally Advanced Non-Small Cell Lung Carcinoma |
Estimated Enrollment: | 250 |
Study Start Date: | March 2005 |
OBJECTIVES:
Primary
Secondary
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.
Ages Eligible for Study: | 18 Years and older |
Genders Eligible for Study: | Both |
Accepts Healthy Volunteers: | No |
DISEASE CHARACTERISTICS:
Histologically confirmed non-small cell lung cancer (NSCLC)
Planning treatment with definitive chemoradiotherapy
PATIENT CHARACTERISTICS:
Age
Performance status
Life expectancy
Hematopoietic
Hepatic
Renal
Other
PRIOR CONCURRENT THERAPY:
Biologic therapy
Chemotherapy
Endocrine therapy
Radiotherapy
Surgery
Study Chair: | Mitchell Machtay, MD | Kimmel Cancer Center (KCC) |
Study Chair: | Mitchell Machtay, MD | Kimmel Cancer Center (KCC) |
Study ID Numbers: | CDR0000362061, ACRIN-6668, RTOG-0235 |
Study First Received: | May 14, 2004 |
Last Updated: | December 20, 2008 |
ClinicalTrials.gov Identifier: | NCT00083083 |
Health Authority: | Unspecified |
stage II non-small cell lung cancer stage IIIA non-small cell lung cancer stage IIIB non-small cell lung cancer |
Thoracic Neoplasms Non-small cell lung cancer Vinblastine Carboplatin Etoposide phosphate Carcinoma Docetaxel Vinorelbine |
Cisplatin Respiratory Tract Diseases Lung Neoplasms Paclitaxel Lung Diseases Carcinoma, Non-Small-Cell Lung Etoposide Neoplasms, Glandular and Epithelial |
Respiratory Tract Neoplasms Neoplasms Neoplasms by Site Neoplasms by Histologic Type Molecular Mechanisms of Pharmacological Action Antineoplastic Agents |
Therapeutic Uses Mitosis Modulators Tubulin Modulators Antimitotic Agents Antineoplastic Agents, Phytogenic Pharmacologic Actions |