ICORG 06-35: a prospective evaluation of PET-CT scan in patients with non-operable or non-resectable non-small cell lung cancer treated by radical 3-dimensional conformal radiation therapy: a phase II study.

BACKGROUND: Radiotherapy (RT) is a key treatment modality in the curative treatment of patients with non-small cell lung cancer (NSCLC). Incorrect definition of the gross, or clinical, target volume is a common source of error which can lead to a reduced probability of tumour control.

OBJECTIVE: This was a pilot and a phase II study. The pilot evaluated the technical feasibility of integrating positron emission tomography-computed tomography (PET-CT) fusion. The primary outcome of the phase II study was to evaluate the safety of PET-CT scan-based RT by evaluating the rate of loco-regional recurrence outside the PET-CT planning target volume (PTV) but within conventional 3-D PTV.

METHODS: Patients underwent standard post-treatment follow-up, including repeated three monthly CT scans of the thorax. In case of loco-regional recurrence, three categories were considered, with only extra-PET scan PTV and intra-CT scan PTV recurrences considered as a failure. Our hypothesis was that the rate of these events would be < 10%.

RESULTS: Twelve patients were recruited; the study closed early due to poor recruitment. The primary endpoint of the pilot was met; it was feasible to deliver a PET-CT-based plan to ≥ 60% of patients. Two patients had intra-PET scan PTV recurrences, six had extra-PET scan PTV and extra-CT, and three patients had both. Another patient had extra-PET scan PTV and extra-CT as well as extra-PET scan PTV and intra-CT scan PTV recurrence.

CONCLUSION/ADVANCES IN KNOWLEDGE: PET-based planning has the potential to reduce radiation treatment volumes because of the avoidance of mediastinal lymph nodes that are PET negative.