Clinical trial NCT00136864: Positron Emission Tomography (PET) Imaging in Stage III Non-small Cell Lung Cancer (PET START Trial)
Official title: The Impact of Positron Emission Tomography (PET) Imaging in Stage III Non-small Cell Lung Cancer: A Prospective Randomized Clinical Trial (PET START Trial)
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE3
Conditions: Non-Small-Cell Lung Carcinoma
Keywords: Positron-Emission Tomography
PET Scan
Non-Small-Cell Lung Carcinoma
Diagnosis
Radiation Oncology
Lung Cancer
Randomized Controlled Trial
Oncology
Radiation Planning
Lead sponsor: Ontario Clinical Oncology Group (OCOG)
Sponsor class: OTHER
Collaborators: name: Ontario Ministry of Health and Long Term Care
First posted: 2005-08-29
Enrollment: 310
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: DIAGNOSTIC

Brief summary: Locally advanced non-small cell lung cancer, NSCLC, (Stage III) is potentially curable with aggressive combined modality therapy (chemotherapy and radiation). Conventional imaging can only evaluate gross anatomic abnormalities but functional imaging with positron emission tomography (PET) may more accurately identify patients who will benefit from aggressive combined modality therapy.

This prospective randomized clinical trial will enroll 400 patients that have undergone conventional staging for lung cancer and have been found to have Stage III NSCLC. The patients will then be randomized to either standard combined modality therapy for Stage III NSCLC or to PET imaging prior to combined modality therapy with curative intent. Based on the PET findings, patients will either be suitable for combined modality therapy with curative intent or not.


Eligibility criteria: Inclusion Criteria:

* Histological or cytological evidence of NSCLC. Must have documented pathology report with histology indicated (e.g. squamous, adenocarcinoma, large cell, NSCLC not otherwise specified).
* Stage III (mediastinal node positive) NSCLC based on conventional staging (e.g. computed tomography \[CT\] scan of chest and upper abdomen, CT or magnetic resonance imaging \[MRI\] of brain, bone scan).
* Suitable for combined modality (chemotherapy and radiation) therapy or radical radiation therapy or trimodality therapy (chemotherapy, radiation and surgery).

Exclusion Criteria:

* Stage IV NSCLC (by conventional staging).
* Small cell lung cancer.
* Poor performance status Eastern Cooperative Oncology Group (ECOG) 3-4.
* Poor pulmonary function precluding radical radiation therapy (Adequate pulmonary reserve for radical radiation therapy. Pulmonary function tests should have forced expiratory volume in 1 second (FEV1) \> 1.0 liter or \> 40% predicted, diffusing capacity of the lung for carbon monoxide (DLCO) \> 45% and/or predicted contralateral FEV1 \> 800 cc based on quantitative ventilation perfusion lung scan).
* Significant concurrent medical problems (e.g. uncontrolled diabetes, active cardiac problems, significant chronic obstructive pulmonary disease).
* Insulin dependent diabetic where requirements for PET imaging may be problematic.
* Unable to lie supine for at least 30 minutes in radiation treatment position for imaging with PET.
* Failure to provide informed consent.
* Previous PET scan relating to recent cancer diagnosis prior to entry into study.
* Pregnant or lactating females.
* Prior thoracic radiation.
* Prior malignancy within 3 years from randomization (except nonmelanotic skin cancer or carcinoma in situ of the cervix).
* Administered more than two cycles of chemotherapy prior to radical radiation therapy or concurrent chemoradiation (as part of induction or sequential chemotherapy prior to randomization) for the current malignancy.

Primary outcomes:
measure: Stage III NSCLC patients upstaged by PET
timeFrame: 2 years
Secondary outcomes:
measure: Overall survival
timeFrame: 2 years
measure: Impact of PET on radiation treatment planning
timeFrame: 2 years
measure: Prognostic ability of PET standard uptake value
timeFrame: 2 years
measure: Number of patients downstaged by PET
timeFrame: 2 years
Other outcomes:
Locations:
city: Hamilton
country: Canada
facility: Juravinski Cancer Centre
state: Ontario
city: London
country: Canada
facility: London Regional Cancer Centre
state: Ontario
city: Ottawa
country: Canada
facility: Ottawa Hospital Regional Cancer Centre
state: Ontario
city: Toronto
country: Canada
facility: Toronto-Sunnybrook Odette Regional Cancer Centre
state: Ontario
city: Toronto
country: Canada
facility: Princess Margaret Hospital
state: Ontario
Study officials:
affiliation: Toronto Sunnybrook Regional Cancer Centre
name: Yee C Ung, MD
role: STUDY_CHAIR
affiliation: Ontario Clinical Oncology Group (OCOG)
name: Mark N Levine, MD
role: PRINCIPAL_INVESTIGATOR
affiliation: Juravinski Cancer Centre
name: William Evans, MD
role: PRINCIPAL_INVESTIGATOR
References: