Fludeoxyglucose F18 Positron Emission Tomography Imaging In Assessing Patients Before and After Treatment for Locally Advanced Non-Small Cell Lung Cancer - Full Text View

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: 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

Resource links provided by NLM:

MedlinePlus related topics: Cancer Health Facilities Lung Cancer Radiation Therapy

Drug Information available for: Cisplatin Paclitaxel Etoposide Carboplatin Fluorodeoxyglucose F18 Vinorelbine Docetaxel Vinorelbine tartrate Vinblastine sulfate Vinblastine

U.S. FDA Resources

Further study details as provided by National Cancer Institute (NCI):

Primary Outcome Measures:

Relationship of survival to post-treatment peak standardized uptake value (SUV) as determined by the imaging institution [ Designated as safety issue: No ]

Secondary Outcome Measures:

Relationship of survival to post-treatment max SUV as determined by the imaging institute [ Designated as safety issue: No ]
Relationship of local control to post-treatment peak and max SUV as determined by the imaging institution [ Designated as safety issue: No ]
Relationship of survival and of local control to pre-treatment peak and max SUV as determined by the imaging institution [ Designated as safety issue: No ]
Reliability between peak and max SUV measurements both pre- and post-treatment [ Designated as safety issue: No ]
Proportion of participants who are either upstaged or downstaged by positron emission tomography scan [ Designated as safety issue: No ]
Reliability between PET scan-defined response to therapy measurements [ Designated as safety issue: No ]
Correlation of Ki-67 expression with peak and max pre-treatment SUV [ Designated as safety issue: No ]
Association between Ki-67 expression and overall survival at 2 years [ Designated as safety issue: No ]

Estimated Enrollment:	250
Study Start Date:	March 2005
Estimated Primary Completion Date:	June 2006 (Final data collection date for primary outcome measure)

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 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

Criteria

DISEASE CHARACTERISTICS:

Histologically confirmed non-small cell lung cancer (NSCLC)
- Clinical stage IIB or III disease
- No small cell carcinoma
- No stage IV disease*
- No diffuse bronchoalveolar subtype
- No planned definitive surgical resection NOTE: *Patients with evidence of stage IV disease by positron emission tomography are eligible if the evidence cannot be confirmed by other means AND the physician still plans to proceed with definitive chemoradiation
Planning treatment with definitive chemoradiotherapy
- May be treated on another Radiation Therapy Oncology Group protocol (except phase I studies) OR with conventional concurrent NSCLC chemoradiotherapy
- Radiotherapy ≥ 60 Gy AND chemotherapy to include concurrent platinum-based therapy
No brain metastases by head CT scan or MRI

PATIENT CHARACTERISTICS:

Age

18 and over

Performance status

Zubrod 0-1

Life expectancy

Not specified

Hematopoietic

Not specified

Hepatic

Not specified

Renal

Not specified

Other

Medically suitable for early concurrent chemoradiotherapy (radiotherapy dose ≥ 60 Gy)
Able to tolerate positron emission tomography imaging
No poorly controlled diabetes (defined as fasting glucose level > 200 mg/dL)
No other malignancy within the past 3 years except basal cell or squamous cell skin cancer or carcinoma in situ
Not pregnant or nursing
Negative pregnancy test
Fertile patients must use effective contraception during and for 3 months after study participation

PRIOR CONCURRENT THERAPY:

Biologic therapy

No anticipated use of adjuvant biologic therapy beyond 14 weeks after the completion of radiotherapy

Chemotherapy

See Disease Characteristics
No anticipated use of adjuvant chemotherapy beyond 14 weeks after the completion of radiotherapy

Endocrine therapy

Not specified

Radiotherapy

See Disease Characteristics
No prior thoracic radiotherapy
No concurrent intensity-modulated radiotherapy

Surgery

See Disease Characteristics

Contacts and Locations

Please refer to this study by its ClinicalTrials.gov identifier: NCT00083083

Show 49 Study Locations

Sponsors and Collaborators

American College of Radiology Imaging Network

National Cancer Institute (NCI)

Radiation Therapy Oncology Group

Investigators

Study Chair:	Mitchell Machtay, MD	Kimmel Cancer Center (KCC)
Study Chair:	Mitchell Machtay, MD	Kimmel Cancer Center (KCC)

More Information

Additional Information:

Clinical trial summary from the National Cancer Institute's PDQ® database This link exits the ClinicalTrials.gov site

No publications provided

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

Keywords provided by National Cancer Institute (NCI):

stage II non-small cell lung cancer
stage IIIA non-small cell lung cancer
stage IIIB non-small cell lung cancer

Study placed in the following topic categories:

Thoracic Neoplasms
Vinblastine
Antimitotic Agents
Carboplatin
Etoposide phosphate
Carcinoma
Docetaxel
Vinorelbine
Cisplatin
Respiratory Tract Diseases

Lung Neoplasms
Paclitaxel
Lung Diseases
Tubulin Modulators
Non-small Cell Lung Cancer
Antineoplastic Agents, Phytogenic
Carcinoma, Non-Small-Cell Lung
Etoposide
Neoplasms, Glandular and Epithelial

Additional relevant MeSH terms:

Thoracic Neoplasms
Respiratory Tract Neoplasms
Neoplasms by Histologic Type
Molecular Mechanisms of Pharmacological Action
Antineoplastic Agents
Mitosis Modulators
Vinblastine
Antimitotic Agents
Carboplatin
Pharmacologic Actions
Carcinoma
Neoplasms

Neoplasms by Site
Vinorelbine
Respiratory Tract Diseases
Paclitaxel
Lung Neoplasms
Therapeutic Uses
Lung Diseases
Tubulin Modulators
Antineoplastic Agents, Phytogenic
Carcinoma, Non-Small-Cell Lung
Neoplasms, Glandular and Epithelial

ClinicalTrials.gov processed this record on July 02, 2009