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The purpose of this study is to perform prospective data analysis on tumor response in terms of local tumor control after 2 years, potential acute and late toxicity and survival in patients with non-metastatic, non-small-cell lung cancer treated by radiotherapy that are medically inoperable due to coexisting comorbidities or that refuse surgery. SBRT regimens used will be 4 fractions of 12 Gy or 3 fractions of 17 Gy depending on tumor location in a risk-adapted approach.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Radiotherapy | Experimental | For centrally located T1 and T2 lesions 4 x 12 Gy over 2 weeks will be delivered. Lesions located peripherally will be treated with 3 x 17 Gy, also delivered within 2 weeks. For both schedules, there should be a minimum of 40 hours and a maximum of 8 days between 2 separate fractions. There should be a maximum of 2 fractions per week. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Radiotherapy (Fractionated stereotactic body radiation) | Radiation | Radiation: Fractionated stereotactic body radiation therapy For centrally located T1 and T2 lesions 4 x 12 Gy over 2 weeks will be delivered. Lesions located peripherally will be treated with 3 x 17Gy, also delivered within 2 weeks. For both schedules, there should be a minimum of 40 hours and a maximum of 8 days between 2 separate fractions. There should be a maximum of 2 fractions per week. |
| Measure | Description | Time Frame |
|---|---|---|
| Toxicity of grade 3+ as assessed by NCI CTCAE v4.0 | To monitor potential toxicity in patients with stage T1,T2,T3 N0 non-small cell lung carcinoma (NSCLC), treated with primary stereotactic body radiation therapy (SBRT) | From start of SBRT until 1 year. After 1 year until end of follow-up for late toxicity |
| Measure | Description | Time Frame |
|---|---|---|
| Time to local progression | Overall survival, local progression free survival, disease free survival, time from start of SBRT to death, local, regional or disseminated recurrence. | every 3 months for the first 2 years. From 3 to 5 years every 6 months. After From start of SBRT until date of death, regional fialure of last follow-up. Aanalysis occurs when all patients have been potentially followed for 24 months. |
| Measure | Description | Time Frame |
|---|---|---|
| Quality of life | Quality of life | baseline at inclusion, at 1 month-, 3 months- and 12 months from start SBRT |
Inclusion Criteria:
Exclusion Criteria:
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| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Christine Collen, MD | Contact | +324763438 | christine.collen@uzbrussel.be | |
| Harijati Versmessen, MD | Contact | +324763407 | harijati.versmessen@uzbrussel.be |
| Name | Affiliation | Role |
|---|---|---|
| Christine Collen, MD | UZ Brussel Radiotherapie dienst | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| UZ Brussel Radiotherapie dienst | Recruiting | Jette | Brussels Capital | 1090 | Belgium |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 26104945 | Derived | Levy A, Guckenberger M, Hurkmans C, Nestle U, Belderbos J, De Ruysscher D, Faivre-Finn C, Le Pechoux C. SBRT Dose and Survival in Non-Small Cell Lung Cancer: In Regard to Koshy et al. Int J Radiat Oncol Biol Phys. 2015 Jul 15;92(4):945-6. doi: 10.1016/j.ijrobp.2015.03.032. No abstract available. |
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|
| ID | Term |
|---|---|
| D002289 | Carcinoma, Non-Small-Cell Lung |
| D008175 | Lung Neoplasms |
| ID | Term |
|---|---|
| D002283 | Carcinoma, Bronchogenic |
| D001984 | Bronchial Neoplasms |
| D012142 | Respiratory Tract Neoplasms |
| D013899 | Thoracic Neoplasms |
| D009371 | Neoplasms by Site |
| D009369 | Neoplasms |
| D008171 | Lung Diseases |
| D012140 | Respiratory Tract Diseases |
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| ID | Term |
|---|---|
| D011878 | Radiotherapy |
| ID | Term |
|---|---|
| D013812 | Therapeutics |
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