Lung Cancer, Metastatic Cancer
Conditions
Keywords
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
Brief summary
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
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.
Interventions
PROCEDUREcomputed tomography
RADIATION3-dimensional conformal radiation therapy
RADIATIONfludeoxyglucose F 18
Sponsors
Cancer Trials Ireland
Study design
Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
DIAGNOSTIC
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
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
Design outcomes
Primary
| Measure | 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
| Measure | Time frame |
|---|---|
| Acute and long-term radiation-induced toxicity | 2016 |
| Comparison of dose delivery to organs at risk, according to planning method | 2016 |
Countries
Ireland
Outcome results
None listed