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| Sponsors and Collaborators: |
American College of Radiology Imaging Network National Cancer Institute (NCI) Radiation Therapy Oncology Group |
| Information provided by: | National Cancer Institute (NCI) |
| ClinicalTrials.gov Identifier: | NCT00083083 |
Purpose
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 |
|
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 |
| MedlinePlus related topics: | Cancer Health Facilities Lung Cancer |
| Drug Information available for: | Carboplatin Etoposide Docetaxel Cisplatin Vinorelbine Vinorelbine tartrate Paclitaxel Etoposide phosphate Vinblastine Vinblastine sulfate Fluorodeoxyglucose F18 |
| 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.
Eligibility
| 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
Contacts and Locations![]() |
Show 49 Study Locations |
| American College of Radiology Imaging Network |
| National Cancer Institute (NCI) |
| Radiation Therapy Oncology Group |
| Study Chair: | Mitchell Machtay, MD | Kimmel Cancer Center (KCC) |
| Study Chair: | Mitchell Machtay, MD | Kimmel Cancer Center (KCC) |
More Information
Clinical trial summary from the National Cancer Institute's PDQ® database 
  |
| Study ID Numbers: | CDR0000362061, ACRIN-6668, RTOG-0235 |
| First Received: | May 14, 2004 |
| Last Updated: | October 8, 2008 |
| ClinicalTrials.gov Identifier: | NCT00083083 |
| Health Authority: | Unspecified |
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