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Positron Emission Tomography Pre- and Post-treatment Assessment For Locally Advanced Non-Small Cell Lung Carcinoma

Phase 2
18 Years
Open (Enrolling)
Lung Cancer

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Trial Information

Positron Emission Tomography Pre- and Post-treatment Assessment For Locally Advanced Non-Small Cell Lung Carcinoma



- 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.


- 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

- 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

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

Inclusion Criteria


- 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

- No brain metastases by head CT scan or MRI



- 18 and over

Performance status

- Zubrod 0-1

Life expectancy

- Not specified


- Not specified


- Not specified


- Not specified


- 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


Biologic therapy

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


- See Disease Characteristics

- No anticipated use of adjuvant chemotherapy beyond 14 weeks after the completion of

Endocrine therapy

- Not specified


- See Disease Characteristics

- No prior thoracic radiotherapy

- No concurrent intensity-modulated radiotherapy


- See Disease Characteristics

Type of Study:


Study Design:

Masking: Open Label, Primary Purpose: Diagnostic

Outcome Measure:

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

Safety Issue:


Principal Investigator

Mitchell Machtay, MD

Investigator Role:

Study Chair

Investigator Affiliation:

Kimmel Cancer Center (KCC)


United States: Federal Government

Study ID:




Start Date:

March 2005

Completion Date:

Related Keywords:

  • Lung Cancer
  • stage II non-small cell lung cancer
  • stage IIIA non-small cell lung cancer
  • stage IIIB non-small cell lung cancer
  • Carcinoma, Non-Small-Cell Lung
  • Lung Neoplasms



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