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 5 with Administrative Update, 8.13.10 [PDF]

SOC-ACRIN 6678 Amendment 5 with Administrative Update, 8.13.10 [PDF]

Informed Consent-ACRIN 6678 [DOC]

Principal Investigator: Wolfgang Weber, MD

Status: In Follow-Up (Closed to Accrual, Patients Still on Treatment)

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 evaluate in an exploratory analysis 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 (for Groups
A and B: Stage IIIB with pleural effusion or Stage IV, who are scheduled to undergo palliative
chemotherapy; for Group C, Stages IIIA, IIIB, or IV, with unspecified therapy) who meet the
eligibility criteria. Patients with previously treated NSCLC may participate so long as they meet
the eligibility criteria.