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| ID | Type | Description | Link |
|---|---|---|---|
| CTRIAL-IE (ICORG) 06-35 | |||
| EU-20925 |
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Low levels of recruitment
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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
Pilot Study- Primary Objectives:
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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| 3-DCRT | Experimental | Patients will receive a total dose of 60-66 Gy in 30-33 fractions with 3-DCRT |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| computed tomography | Procedure |
| ||
| 3-dimensional conformal radiation therapy |
| 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 |
| 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 |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Pierre Thirion, MD | Saint Luke's Hospital | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| St Luke's Radiation Oncology Network | Dublin | 6 | Ireland |
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| Radiation |
|
| fludeoxyglucose F 18 | Radiation |
|
| radiation therapy treatment planning/simulation | Radiation |
|
| ID | Term |
|---|---|
| D008175 | Lung Neoplasms |
| D009362 | Neoplasm Metastasis |
| D000077192 | Adenocarcinoma of Lung |
| D016066 | Pleural Effusion, Malignant |
| D002289 | Carcinoma, Non-Small-Cell Lung |
| ID | Term |
|---|---|
| D012142 | Respiratory Tract Neoplasms |
| D013899 | Thoracic Neoplasms |
| D009371 | Neoplasms by Site |
| D009369 | Neoplasms |
| D008171 | Lung Diseases |
| D012140 | Respiratory Tract Diseases |
| D009385 | Neoplastic Processes |
| D010335 | Pathologic Processes |
| D013568 | Pathological Conditions, Signs and Symptoms |
| D000230 | Adenocarcinoma |
| D002277 | Carcinoma |
| D009375 | Neoplasms, Glandular and Epithelial |
| D009370 | Neoplasms by Histologic Type |
| D010997 | Pleural Neoplasms |
| D010996 | Pleural Effusion |
| D010995 | Pleural Diseases |
| D002283 | Carcinoma, Bronchogenic |
| D001984 | Bronchial Neoplasms |
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| ID | Term |
|---|---|
| D020266 | Radiotherapy, Conformal |
| D019788 | Fluorodeoxyglucose F18 |
| ID | Term |
|---|---|
| D011881 | Radiotherapy, Computer-Assisted |
| D011878 | Radiotherapy |
| D013812 | Therapeutics |
| D003847 | Deoxyglucose |
| D003837 | Deoxy Sugars |
| D002241 | Carbohydrates |
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