Alternate Title
Basic Trial Information
Objectives
Entry Criteria
Expected Enrollment
Outcomes
Outline
Trial Contact Information
Registry Information

Alternate Title

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

Basic Trial Information

Phase	Type	Status	Age	Sponsor	Protocol IDs
Phase II	Biomarker/Laboratory analysis, Diagnostic	Closed	18 and over	NCI	ACRIN-6668 RTOG-0235, NCT00083083

Objectives

Primary

1. 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

1. Determine whether max SUV for FDG-PET shortly after definitive chemoradiotherapy is predictive of long-term survival in these patients.
2. 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.
3. Determine whether pre-treatment imaging using these techniques is predictive of long-term survival and local disease control in these patients.
4. Correlate, if possible, Ki-67 expression with overall survival of patients assessed with these imaging techniques.

Entry 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

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

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

Expected Enrollment

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.

Outcomes

Relationship of survival to post-treatment peak standardized uptake value (SUV) as determined by the imaging institution

Relationship of survival to post-treatment max SUV as determined by the imaging institute
Relationship of local control to post-treatment peak and max SUV as determined by the imaging institution
Relationship of survival and of local control to pre-treatment peak and max SUV as determined by the imaging institution
Reliability between peak and max SUV measurements both pre- and post-treatment
Proportion of participants who are either upstaged or downstaged by positron emission tomography scan
Reliability between PET scan-defined response to therapy measurements
Correlation of Ki-67 expression with peak and max pre-treatment SUV
Association between Ki-67 expression and overall survival at 2 years

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.

Trial Contact Information

Trial Lead Organizations

American College of Radiology Imaging Network

Mitchell Machtay, MD, Protocol chair		Ph: 215-955-6706; 800-533-3669 Email: mitchell.machtay@mail.tju.edu

Radiation Therapy Oncology Group

Mitchell Machtay, MD, Protocol chair		Ph: 215-955-6706; 800-533-3669 Email: mitchell.machtay@mail.tju.edu

Registry Information
Official Title		Positron Emission Tomography Pre- and Post-treatment Assessment For Locally Advanced Non-Small Cell Lung Carcinoma
Trial Start Date		2005-03-01
Trial Completion Date		2006-06-01 (estimated)
Registered in ClinicalTrials.gov		NCT00083083
Date Submitted to PDQ		2004-03-17
Information Last Verified		2007-10-29
NCI Grant/Contract Number		CA080098

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