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

Study Overview
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Brief Summary
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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

Detailed Description
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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.

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

Conditions
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Lung Cancer, Metastatic Cancer

Intervention / Treatment
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* Procedure: computed tomography
* Radiation: 3-dimensional conformal radiation therapy
* Radiation: fludeoxyglucose F 18
* Radiation: radiation therapy treatment planning/simulation


Participation Criteria
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Eligibility Criteria
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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

Ages Eligible for Study
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Minimum Age: 18 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Diagnostic
Intervention Model: Single Group Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: 3-DCRT<br>Patients will receive a total dose of 60-66 Gy in 30-33 fractions with 3-DCRT | Procedure: computed tomography<br> <br> Radiation: 3-dimensional conformal radiation therapy<br> <br> Radiation: fludeoxyglucose F 18<br> <br> Radiation: radiation therapy treatment planning/simulation<br> <br> |

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Rate of successful delivery of PET-CT scan based 3-D conformal radiotherapy (Pilot) |  | 2016 | 
| Rate of loco-regional recurrence outside the PET-CT planning target volume (PTV) but within conventional 3-D PTV (Phase II) |  | 2016 | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Acute and long-term radiation-induced toxicity |  | 2016 | 
| Comparison of dose delivery to organs at risk, according to planning method |  | 2016 | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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adenocarcinoma of the lung, large cell lung cancer, squamous cell lung cancer, malignant pleural effusion, stage IIIA non-small cell lung cancer, stage IIIB non-small cell lung cancer, stage IA non-small cell lung cancer, stage IB non-small cell lung cancer, stage IIA non-small cell lung cancer, stage IIB non-small cell lung cancer