Ignite Creation Date:
2024-05-05 @ 11:36 AM
Last Modification Date:
2024-10-26 @ 9:10 AM
Study NCT ID:
NCT00083083
Status:
UNKNOWN
Last Update Posted:
2011-03-01
First Post:
2004-05-14
Brief Title:
Fludeoxyglucose F18 Positron Emission Tomography Imaging In Assessing Patients Before and After Treatment for Locally Advanced Non-Small Cell Lung Cancer
Sponsor:
American College of Radiology Imaging Network
Organization:
National Cancer Institute NCI
Study Overview
Official Title:
Positron Emission Tomography Pre- and Post-treatment Assessment For Locally Advanced Non-Small Cell Lung Carcinoma
Status:
UNKNOWN
Status Verified Date:
2007-10
Last Known Status:
ACTIVE_NOT_RECRUITING
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
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 patients 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
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
Determine whether peak standardized uptake value SUV for fludeoxyglucose F 18 positron emission tomography FDG-PET shortly after definitive chemoradiotherapy is predictive of long-term survival of patients with inoperable stage IIB or III non-small cell lung cancer
Secondary
Determine whether max SUV for FDG-PET shortly after definitive chemoradiotherapy is predictive of long-term survival in these patients
Determine whether post-treatment imaging using peak and max SUV for FDG-PET shortly after definitive chemoradiotherapy is predictive of local disease control in these patients
Determine whether pre-treatment imaging using these techniques is predictive of long-term survival and local disease control in these patients
Correlate if possible Ki-67 expression with overall survival of patients assessed with these imaging techniques
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 IIBIIIA disease and at least 75 with stage IIIB disease will be accrued for this study within 2 years
Primary
Determine whether peak standardized uptake value SUV for fludeoxyglucose F 18 positron emission tomography FDG-PET shortly after definitive chemoradiotherapy is predictive of long-term survival of patients with inoperable stage IIB or III non-small cell lung cancer
Secondary
Determine whether max SUV for FDG-PET shortly after definitive chemoradiotherapy is predictive of long-term survival in these patients
Determine whether post-treatment imaging using peak and max SUV for FDG-PET shortly after definitive chemoradiotherapy is predictive of local disease control in these patients
Determine whether pre-treatment imaging using these techniques is predictive of long-term survival and local disease control in these patients
Correlate if possible Ki-67 expression with overall survival of patients assessed with these imaging techniques
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 IIBIIIA disease and at least 75 with stage IIIB disease will be accrued for this study within 2 years
Study Oversight
Has Oversight DMC:
Is a FDA Regulated Drug?:
Is a FDA Regulated Device?:
Is an Unapproved Device?:
Is a PPSD?:
Is a US Export?:
Is an FDA AA801 Violation?:
Secondary IDs
| Secondary ID | Type | Domain | Link |
|---|---|---|---|
| RTOG-0235 | None | None | None |
| ACRIN-6668 | None | None | None |