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| Sponsor: | American College of Radiology Imaging Network |
|---|---|
| Collaborators: |
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: paclitaxel Drug: vinblastine Drug: vinorelbine ditartrate Genetic: gene expression analysis Procedure: positron emission tomography Radiation: fludeoxyglucose F 18 Radiation: 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 |
| Estimated Primary Completion Date: | June 2006 (Final data collection date for primary outcome measure) |
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| Study Chair: | Mitchell Machtay, MD | Kimmel Cancer Center (KCC) |
| Study Chair: | Mitchell Machtay, MD | Kimmel Cancer Center (KCC) |
More Information
| Responsible Party: | Kimmel Cancer Center at Thomas Jefferson University - Philadelphia ( Mitchell Machtay ) |
| Study ID Numbers: | CDR0000362061, ACRIN-6668, RTOG-0235 |
| Study First Received: | May 14, 2004 |
| Last Updated: | May 29, 2009 |
| ClinicalTrials.gov Identifier: | NCT00083083 History of Changes |
| Health Authority: | United States: Federal Government |
|
stage II non-small cell lung cancer stage IIIA non-small cell lung cancer stage IIIB non-small cell lung cancer |
|
Thoracic Neoplasms Molecular Mechanisms of Pharmacological Action Antineoplastic Agents Physiological Effects of Drugs Vinblastine Docetaxel Neoplasms by Site Respiratory Tract Diseases Cisplatin Lung Neoplasms Therapeutic Uses Etoposide Respiratory Tract Neoplasms Neoplasms by Histologic Type |
Mitosis Modulators Antimitotic Agents Carboplatin Pharmacologic Actions Carcinoma Neoplasms Vinorelbine Radiation-Sensitizing Agents Paclitaxel Lung Diseases Tubulin Modulators Carcinoma, Non-Small-Cell Lung Antineoplastic Agents, Phytogenic Neoplasms, Glandular and Epithelial |