|
Home
Search
Study Topics
Glossary
|
![]() |
![]() |
|
![]() |
|
![]() |
|
![]() |
![]() |
![]() |
|
![]() |
![]() |
||||||||||||||||||||||||||||||||||||
| Tracking Information | |||||||||
|---|---|---|---|---|---|---|---|---|---|
| First Received Date ICMJE | May 14, 2004 | ||||||||
| Last Updated Date | May 29, 2009 | ||||||||
| Start Date ICMJE | March 2005 | ||||||||
| Estimated Primary Completion Date | June 2006 (final data collection date for primary outcome measure) | ||||||||
| Current Primary Outcome Measures ICMJE |
Relationship of survival to post-treatment peak standardized uptake value (SUV) as determined by the imaging institution [ Designated as safety issue: No ] | ||||||||
| Original Primary Outcome Measures ICMJE |
Relationship of survival to post-treatment peak standardized uptake value (SUV) as determined by the imaging institution | ||||||||
| Change History | Complete list of historical versions of study NCT00083083 on ClinicalTrials.gov Archive Site | ||||||||
| Current Secondary Outcome Measures ICMJE |
|
||||||||
| Original Secondary Outcome Measures ICMJE |
|
||||||||
| Descriptive Information | |||||||||
| Brief Title ICMJE | Fludeoxyglucose F18 Positron Emission Tomography Imaging In Assessing Patients Before and After Treatment for Locally Advanced Non-Small Cell Lung Cancer | ||||||||
| Official Title ICMJE | Positron Emission Tomography Pre- and Post-Treatment Assessment For Locally Advanced Non-Small Cell Lung Carcinoma | ||||||||
| Brief Summary | 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. |
||||||||
| Detailed Description | 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. |
||||||||
| Study Phase | Phase II | ||||||||
| Study Type ICMJE | Interventional | ||||||||
| Study Design ICMJE | Diagnostic, Open Label | ||||||||
| Condition ICMJE | Lung Cancer | ||||||||
| Intervention ICMJE |
|
||||||||
| Study Arms / Comparison Groups | |||||||||
| Publications * | |||||||||
|
* Includes publications given by the data provider as well as publications identified by National Clinical Trials Identifier (NCT ID) in Medline. |
|||||||||
| Recruitment Information | |||||||||
| Recruitment Status ICMJE | Active, not recruiting | ||||||||
| Estimated Enrollment ICMJE | 250 | ||||||||
| Completion Date | |||||||||
| Estimated Primary Completion Date | June 2006 (final data collection date for primary outcome measure) | ||||||||
| Eligibility Criteria ICMJE | DISEASE CHARACTERISTICS:
PATIENT CHARACTERISTICS: Age
Performance status
Life expectancy
Hematopoietic
Hepatic
Renal
Other
PRIOR CONCURRENT THERAPY: Biologic therapy
Chemotherapy
Endocrine therapy
Radiotherapy
Surgery
|
||||||||
| Gender | Both | ||||||||
| Ages | 18 Years and older | ||||||||
| Accepts Healthy Volunteers | No | ||||||||
| Contacts ICMJE | Contact information is only displayed when the study is recruiting subjects | ||||||||
| Location Countries ICMJE | United States, Canada, Korea, Republic of | ||||||||
| Administrative Information | |||||||||
| NCT ID ICMJE | NCT00083083 | ||||||||
| Responsible Party | Mitchell Machtay, Kimmel Cancer Center at Thomas Jefferson University - Philadelphia | ||||||||
| Study ID Numbers ICMJE | CDR0000362061, ACRIN-6668, RTOG-0235 | ||||||||
| Study Sponsor ICMJE | American College of Radiology Imaging Network | ||||||||
| Collaborators ICMJE |
|
||||||||
| Investigators ICMJE |
|
||||||||
| Information Provided By | National Cancer Institute (NCI) | ||||||||
| Verification Date | October 2007 | ||||||||
|
ICMJE Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP |
|||||||||