Clinical trial NCT01314677: Fludeoxyglucose F 18 PET/CT Scans in Predicting Therapy Response in Patients With Stage IIIA Non-Small Cell Lung Cancer Undergoing Chemoradiation
Official title: Open Label Randomized Trial of Early Assessment of Therapy Response Using 18FDG-PET/CT in Patients With Marginally Resectable Stage IIIA (N2) Non-Small Cell Lung Cancer (NSCLC) Treated With Induction Concurrent Chemoradiation Followed by Resection and Adjuvant Chemotherapy
Study type: INTERVENTIONAL
Overall status: WITHDRAWN
Phase: NA
Conditions: Stage IIIA Non-small Cell Lung Cancer
Lead sponsor: City of Hope Medical Center
Sponsor class: OTHER
Collaborators: name: National Cancer Institute (NCI)
First posted: 2011-03-14
Enrollment: 0
Sex: ALL
Standard ages: CHILD
ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: SINGLE_GROUP
Primary purpose: DIAGNOSTIC

Brief summary: This clinical trial studies fludeoxyglucose F 18 (FDG) positron emission tomography (PET)/computed tomography (CT) in predicting chemoradiation therapy (CRT) failure in patients with stage IIIA non-small cell lung cancer (NSCLC). Diagnostic procedures, such as FDG PET/CT, may help predict CRT failure. Comparing diagnostic results during CRT may help doctors predict a patient's response to treatment and help plan the best treatment

Detailed description: PRIMARY OBJECTIVES:

I. To determine whether early response of the research positron emission tomography (PET)-computed tomography(CT) scan measured by change in Standard Uptake Value (SUV)max relative to baseline scan can predict induction chemoradiation therapy (CRT) failures sooner than post-treatment PET-CT scan.

II. To determine the optimal timing for 18FDG PET-CT that best predicts for induction CRT failure.

SECONDARY OBJECTIVES:

I. To correlate early 18 fludeoxyglucose (FDG) PET-CT response metrics with pathologic response, progression-free survival separately for: induction CRT failures vs. non-failures, or overall survival separately for induction CRT failures vs. non-failures.

OUTLINE: Patients are randomized to 1 of 3 groups.

Patients undergo a baseline FDG PET/CT scan and receive standard radiotherapy (RT) for 28 fractions with concurrent chemotherapy.

GROUP A: Patients undergo a FDG PET/CT scan between RT fractions 5-6 (before course 2 of chemotherapy).

GROUP B: Patients undergo a FDG PET/CT scan between RT fractions 10-11 (before course 3 of chemotherapy).

GROUP C: Patients undergo a FDG PET/CT scan between RT fractions 15-16 (before course 4 of chemotherapy).

Approximately 6 weeks after completion of CRT, patients undergo a FDG PET/CT scan and undergo standard tumor resection.

After completion of study treatment, patients are followed up every 3 months for 2 years and then every 6 months thereafter.

Eligibility criteria: Inclusion Criteria:

* All patients with marginally resectable IIIA (N2) NSCLC undergoing induction CRT will be eligible for this imaging trial; patients will be screened by the chest tumor board for entry
* Undergoing or plan to undergo induction chemoradiation

Exclusion Criteria:

* Poorly controlled or uncontrolled diabetes mellitus, with blood glucose \> 200 mg/dl
* Have allergies or medical contra-indications to FDG or intravenous (IV) contrast
* Medical contra-indications to obtaining CT or PET scans
* Pre-authorization denial of coverage by insurance providers of clinical staging and restaging PET-CT scans

Primary outcomes:
measure: Induction therapy failure
timeFrame: 6 weeks after completion of chemoradiation therapy (CRT)
measure: Early positron emission tomography (PET) response of group A
timeFrame: Baseline and between standard radiotherapy (RT) fractions 5-6
measure: Early positron emission tomography (PET) response of group B
timeFrame: Baseline and between standard radiotherapy (RT) fractions 10-11
measure: Early positron emission tomography (PET) response of group C
timeFrame: Baseline and between standard radiotherapy (RT) fractions 15-16
Secondary outcomes:
measure: Pathologic response
timeFrame: 6 weeks after completion of chemoradiation therapy (CRT)
measure: Progression-free survival
timeFrame: Every 3 months for 2 years and every 6 months thereafter
measure: Overall survival
timeFrame: Every 3 months for 2 years and every 6 months thereafter
Other outcomes:
Locations:
Study officials:
affiliation: City of Hope Medical Center
name: Khanh Nguyen
role: PRINCIPAL_INVESTIGATOR
References: