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
- Conditions
- Metastatic CancerLung Cancer
- Interventions
- Procedure: computed tomographyRadiation: 3-dimensional conformal radiation therapyRadiation: fludeoxyglucose F 18Radiation: radiation therapy treatment planning/simulation
- Registration Number
- NCT00958321
- Lead Sponsor
- Cancer Trials Ireland
- 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.
Recruitment & Eligibility
- Status
- TERMINATED
- Sex
- All
- Target Recruitment
- 40
- 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
- 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
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- SINGLE_GROUP
- Arm && Interventions
Group Intervention Description 3-DCRT radiation therapy treatment planning/simulation Patients will receive a total dose of 60-66 Gy in 30-33 fractions with 3-DCRT 3-DCRT computed tomography Patients will receive a total dose of 60-66 Gy in 30-33 fractions with 3-DCRT 3-DCRT 3-dimensional conformal radiation therapy Patients will receive a total dose of 60-66 Gy in 30-33 fractions with 3-DCRT 3-DCRT fludeoxyglucose F 18 Patients will receive a total dose of 60-66 Gy in 30-33 fractions with 3-DCRT
- Primary Outcome Measures
Name Time Method 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
Name Time Method Acute and long-term radiation-induced toxicity 2016 Comparison of dose delivery to organs at risk, according to planning method 2016
Trial Locations
- Locations (1)
St Luke's Radiation Oncology Network
🇮🇪Dublin, Ireland