Positron Emission Tomography and Computed Tomography in Planning Treatment for Patients Undergoing 3-Dimensional Conformal Radiation Therapy for Non-Small Cell Lung Cancer That Cannot Be Removed by Surgery. ICORG 06-35

Prospective Evaluation of PET-CT Scan in Patients With Non-operable or Non-resectable NSCLC Treated by Radical 3-Dimensional Conformal Radiation Therapy

RATIONALE: Diagnostic procedures, such as positron emission tomography and computed tomography, may help learn the extent of disease and allow doctors to plan 3-dimensional conformal radiation therapy.

PURPOSE: This phase II trial is studying the side effects of positron emission tomography and computed tomography and to see how well it works in planning treatment for patients undergoing 3-dimensional conformal radiation therapy for non-small cell lung cancer that cannot be removed by surgery.

This is a clinical study, as the patient will be treated using the PET-CT-GTV: - The pilot study is investigating the technological feasibility - The Phase II study will be a 2-stage Phase II study

Pilot Study- Primary Objectives:

• Prospective evaluation of the technical feasibility of integrating PET-CT fusion in St Luke's Hospital
• Rate of PET-CT Scan based treatment delivery

Pilot Study- Secondary Objectives:

-Comparison of GTV, PTV and OAR DVHs between conventional 3-DCRT plan and PET-CT based 3-DCRT plan.

Phase II Study- Primary Objective:

-The safety of PET-CT scan based radiotherapy, with regard to loco-regional disease control.

Phase II Study- Secondary Objectives:

-Comparison of GTV, PTV and OAR DVHs between conventional 3-DCRT plan and PET-CT based 3-DCRT plan.

Inclusion Criteria:

• Histologically proven (biopsy or cytology) NSCLC (SCC, Adenocarcinoma, Large Cell)
• TNM clinical non-operable stage I/II and non-resectable stage IIIa/b without pleural effusion
• Measurable disease
• No other malignancy, except non-melanomatous skin cancer, within 5 years prior to participation in this study; the disease-free interval from any prior carcinoma must be continuous
• Patient suitable for radical 3-DCRT
• ECOG-Performance status ≤ 2 / KPS > or equal to 60
• Weight loss <10% within the 3 months prior to diagnosis
• No prior radiotherapy to the thorax
• Patient is suitable for lung-board immobilisation
• No chemotherapy received prior to planning PET-CT scan
• Age 18 and over
• Provision of written informed consent

Exclusion Criteria:

• Evidence of any other significant clinical disorder or laboratory finding that makes it undesirable for the patient to participate in the trial or if it is felt by the research / medical team that the patient may not be able to comply with the protocol.
• FEV1 < 1