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[18F]FDG-PET/CT as a Predictive Marker of Tumor Response and Patient Outcome: Prospective Validation in Non-Small Cell Lung Cancer


Phase 2
18 Years
N/A
Not Enrolling
Both
Lung Cancer

Thank you

Trial Information

[18F]FDG-PET/CT as a Predictive Marker of Tumor Response and Patient Outcome: Prospective Validation in Non-Small Cell Lung Cancer


OBJECTIVES:

- Determine whether a metabolic response, defined as a 25% decrease in peak tumor
standardized uptake value (SUV) after the first course of chemotherapy, provides early
prediction of treatment outcome (tumor response and patient survival) in patients with
stage IIIB or IV non-small cell lung cancer undergoing platinum-based chemotherapy.

- Determine the test-retest reproducibility of quantitative assessment of tumor
fludeoxyglucose F 18 (^18FDG) uptake in these patients.

- Determine the time course of treatment-induced changes in tumor ^18FDG uptake in these
patients.

- Determine, in an exploratory analysis, changes in tumor volume during chemotherapy by
multislice CT scanning in these patients.

OUTLINE: This is a prospective, multicenter study. Patients are assigned to 1 of 3 groups.

- Group I: Patients undergo fludeoxyglucose F 18 (^18FDG) positron emission tomography
(PET)/CT scanning twice and 1-2 volumetric CT scanning (1-7 days apart) before starting
treatment with platinum-based chemotherapy. Patients undergo additional ^18FDG PET/CT
scan and a volumetric CT scan once between the first and second course of chemotherapy.

- Group II: Patients undergo ^18FDG PET/CT scan and volumetric CT scanning once before
starting treatment with platinum-based chemotherapy. Patients undergo additional ^18FDG
PET/CT scan and volumetric CT scanning once between the first and second course of
chemotherapy, and may undergo once between the second and third course of chemotherapy.

- Group III: Patients undergo ^18FDG PET/CT scanning twice (up to 1 week apart) before
starting any treatment.

In groups I and II, patients also undergo standard follow-up CT scanning every 6 weeks
(i.e., every other chemotherapy course) for up to 18 weeks.

After completion of chemotherapy, patients are followed every 3 months for up to 1 year.

Biomarker

- Imaging: See

- provided by American College of Radiology Network.

PROJECTED ACCRUAL: A total of 285 patients will be accrued for this study.

Inclusion Criteria


DISEASE CHARACTERISTICS:

- Histologically or cytologically confirmed non-small cell lung cancer

- Newly diagnosed stage IIIB (with malignant pleural effusion) or stage IV disease
(Group I and II), or newly diagnosed stage IIIA, IIIB, or IV (Group III)
determined by all of the following:

- CT scan or MRI of the chest and upper abdomen (including liver and adrenal
glands) within the past 4 weeks

- History/physical examination within the past 6 weeks

- CT scan or MRI of the brain within the past 4 weeks, if there is headache,
mental/physical impairment, or other signs or symptoms suggesting brain
metastases within the past 2 months

- No small cell carcinoma

- No pure bronchioloalveolar carcinoma

- Patients with recurrent or metastatic disease are eligible provided they meet 1 of
the following criteria:

- Received surgery or radiotherapy for treatment of the primary tumor and
locoregional disease ≥ 3 months prior to study entry AND have a measurable
lesion in the chest

- Received chemotherapy in the adjuvant setting or as part of combined modality
therapy for locoregional disease ≥ 3 months prior to recurrent or metastatic
disease diagnosis AND have a measurable lesion in the chest

- Measurable disease, defined as at least 1 measurable primary tumor or other
intrathoracic/supraclavicular lesion ≥ 2 cm

- Scheduled to be treated with a platinum-based dual-agent chemotherapy regimen
administered at 3-week intervals with or without bevacizumab or cetuximab (Group I
and II)

- Scheduled to be treated with standard chemotherapy in the current protocol, other
standard chemotherapy, experimental chemotherapy, or other treatment including no
treatment (Group III)

- No symptomatic brain metastases (Groups I and II only)

PATIENT CHARACTERISTICS:

- ECOG performance status 0-2 (Groups I and II only)

- Group III may include potential participants regardless of ECOG performance
status score

- Not pregnant or nursing

- Negative pregnancy test

- Fertile patients must use effective contraception

- Able to tolerate positron emission tomography (PET)/CT scanning

- No contraindication to chemotherapy and PET/CT scanning, as demonstrated by
laboratory testing

- No poorly controlled diabetes (i.e., fasting glucose level > 150 mg/dL) despite
attempts to improve glucose control by fasting duration and adjustment of medications

- No prior malignancy other than basal cell or squamous cell carcinoma of the skin,
carcinoma in situ, or other cancer from which the patient has been disease free for ≥
3 years (Groups I and II)

- Prior malignancy is not an exclusion factor for Group III

- No clinical or radiographic signs of post-obstructive pneumonia

PRIOR CONCURRENT THERAPY:

- See Disease Characteristics

- More than 3 months since prior thoracic radiotherapy, lung surgery, or chemotherapy

- Prior chemotherapy in the adjuvant setting or as part of a combined modality regimen
for locoregional disease that was given ≥ 3 months prior to diagnosis of recurrent or
metastatic disease allowed

- No planned treatment with any targeted biologic therapy including gefitinib or
erlotinib hydrochloride (Group I and II)

- No concurrent chemoradiotherapy

- No concurrent bevacizumab

Type of Study:

Interventional

Study Design:

Allocation: Non-Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Diagnostic

Outcome Measure:

Prediction of 1-year overall survival as measured by monitoring changes in tumor metabolic response during the first course of chemotherapy

Outcome Time Frame:

One year

Safety Issue:

No

Principal Investigator

Wolfgang Weber, MD

Investigator Role:

Study Chair

Investigator Affiliation:

Jonsson Comprehensive Cancer Center

Authority:

United States: Federal Government

Study ID:

CDR0000527084

NCT ID:

NCT00424138

Start Date:

March 2007

Completion Date:

August 2011

Related Keywords:

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

Name

Location

Jonsson Comprehensive Cancer Center at UCLALos Angeles, California  90095-1781