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| ID | Type | Description | Link |
|---|---|---|---|
| ICORG-06-34 | |||
| EU-21056 |
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RATIONALE: 3-dimensional conformal radiation therapy may lessen side effects caused by palliative radiation therapy and improve the quality of life of patients with lung cancer.
PURPOSE: This clinical trial is studying how well 3-dimensional conformal radiation therapy works in reducing the side effects of palliative radiation in patients with lung cancer.
The primary purpose of this study is to demonstrate that using technically sophisticated 3-dimensional conformal radiation therapy for the palliative treatment of lung cancer patients will result in equivalent degrees of symptom relief and a reduction in the primary endpoint of oesophagitis.
Single arm therapeutic clinical study.
RT Treatment Regimens:
17 Gy/2 fractions or 20Gy/5 fractions or 39Gy/13 fractions
Primary Endpoint:
-The occurrence of Grade 3 or higher oesophagitis in the interval between start and 1-month post completion of treatment as determined by CTCAE Version 4.02
Patients will be assessed pre treatment, during treatment, 2 weeks post completion of treatment, one month post completion of treatment, three months post completion of treatment, and three monthly thereafter
-All patients who complete treatment (and whose on-treatment toxicity is documented) will be evaluable.
Secondary Endpoint:
Safety Endpoint:
-Radio-induced oesophagitis, acute and long term, using the CTCAE Version 4.02.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| A | Experimental | A clinical trial using 3-dimensional conformal radiation therapy to reduce the toxicity of palliative radiation for lung cancer |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| questionnaire administration | Other |
| ||
| quality-of-life assessment |
| Measure | Description | Time Frame |
|---|---|---|
| Occurrence of esophagitis grade 3 or higher according to CTCAE Version 4.02 | 2015 | |
| Quality of life as assessed using the EORTC QLQ-C15-PAL (Version 1) questionnaire and the Lung Specific Module (LC 13) | 2015 |
| Measure | Description | Time Frame |
|---|---|---|
| Local intra-thoracic symptoms | 2015 |
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Inclusion Criteria:
Exclusion Criteria:
-In the opinion of the Investigator, any evidence of severe or uncontrolled systematic disease (e.g. unstable or uncompensated respiratory, cardiac, hepatic or renal disease)
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| Name | Affiliation | Role |
|---|---|---|
| John Gerard Armstrong, MD, MB, MRCPI | Saint Luke's Hospital | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| St Luke's Radiation Oncology Network (SLRON) | Dublin | 6 | Ireland | |||
| Galway University Hospital |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 29548561 | Derived | McDermott RL, Armstrong JG, Thirion P, Dunne M, Finn M, Small C, Byrne M, O'Shea C, O'Sullivan L, Shannon A, Kelly E, Hacking DJ. Cancer Trials Ireland (ICORG) 06-34: A multi-centre clinical trial using three-dimensional conformal radiation therapy to reduce the toxicity of palliative radiation for lung cancer. Radiother Oncol. 2018 May;127(2):253-258. doi: 10.1016/j.radonc.2018.02.028. Epub 2018 Mar 13. |
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|
| 3-dimensional conformal radiation therapy | Radiation |
|
| palliative radiation therapy | Radiation |
|
| whole-brain radiation therapy | Radiation |
|
| Galway |
| Ireland |
| ID | Term |
|---|---|
| D008175 | Lung Neoplasms |
| D002289 | Carcinoma, Non-Small-Cell Lung |
| D055752 | Small Cell Lung Carcinoma |
| ID | Term |
|---|---|
| D012142 | Respiratory Tract Neoplasms |
| D013899 | Thoracic Neoplasms |
| D009371 | Neoplasms by Site |
| D009369 | Neoplasms |
| D008171 | Lung Diseases |
| D012140 | Respiratory Tract Diseases |
| D002283 | Carcinoma, Bronchogenic |
| D001984 | Bronchial Neoplasms |
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| ID | Term |
|---|---|
| D020266 | Radiotherapy, Conformal |
| ID | Term |
|---|---|
| D011881 | Radiotherapy, Computer-Assisted |
| D011878 | Radiotherapy |
| D013812 | Therapeutics |
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