Positron Emission Tomography (PET) Imaging in Stage III Non-small Cell Lung Cancer (PET START Trial)

Non-Small-Cell Lung Carcinoma Clinical 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)

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT00136864
• Other study ID #: CTA-Control-087276
• Status: Completed
• Phase: Phase 3
• First received: August 25, 2005
• Last updated: November 17, 2011
• Start date: August 2004
• Est. completion date: September 2011

Study information

• Verified date: November 2011
• Source: Ontario Clinical Oncology Group (OCOG)
• Contact: n/a
• Is FDA regulated: No
• Health authority: Canada: Health Canada
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 310
• Est. completion date: September 2011
• Est. primary completion date: November 2009
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years and older

Eligibility

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.

Study Design

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

Related Conditions & MeSH terms

• Carcinoma, Non-Small-Cell Lung
• Lung Neoplasms
• Non-Small-Cell Lung Carcinoma

Intervention

Procedure:
• PET Diagnostic Imaging
Patients in the PET group will undergo the standard diagnostic tests plus PET to determine those suitable for combined modality therapy

Locations

Country	Name	City	State
Canada	Juravinski Cancer Centre	Hamilton	Ontario
Canada	London Regional Cancer Centre	London	Ontario
Canada	Ottawa Hospital Regional Cancer Centre	Ottawa	Ontario
Canada	Princess Margaret Hospital	Toronto	Ontario
Canada	Toronto-Sunnybrook Odette Regional Cancer Centre	Toronto	Ontario

Sponsors (2)

Lead Sponsor	Collaborator
Ontario Clinical Oncology Group (OCOG)	Ontario Ministry of Health and Long Term Care

Country where clinical trial is conducted

Canada, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Stage III NSCLC patients upstaged by PET		2 years	No
Secondary	Overall survival		2 years	No
Secondary	Impact of PET on radiation treatment planning		2 years	No
Secondary	Prognostic ability of PET standard uptake value		2 years	No
Secondary	Number of patients downstaged by PET		2 years	No