FDG-PET/CT as a Predictive Marker of Tumor Response and Patient Outcome:
Prospective Validation in Non-small Cell Lung Cancer

Protocol Documents

Protocol-ACRIN 6678 Amendment 2, 10.8.08 [PDF]

SOC-ACRIN 6678 Amendment 2, 10.8.08 [PDF]

Informed Consent-ACRIN 6678 [DOC]

Principal Investigator: Wolfgang Weber, MD

Status: Open

Main Objectives:

• To test whether a metabolic response, defined as a ≥ 25% decrease in peak tumor SUV post-cycle 1 of chemotherapy, provides early prediction of treatment outcome (tumor response and patient survival).
• To determine the test-retest reproducibility of quantitative assessment of tumor FDG uptake by SUVs.
• To study the time course of treatment induced changes in tumor FDG uptake.
• To evaluate in an exploratory analysis changes in tumor volume during chemotherapy by multislice CT.

Participants:  Eligible participants for this trial are patients with advanced NSCLC (Stage IIIB with pleural effusion or Stage IV) who meet the eligibility criteria, and who will receive platinum-based doublet chemotherapy in three week cycles as recommended by the American Society of Clinical Oncology (ASCO) 2003 guidelines (51). Patients with previously treated NSCLC may participate so long as they meet the eligibility criteria.