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| ID | Type | Description | Link |
|---|---|---|---|
| 2012-A00413-40 | Other Identifier | ANSM number | |
| ET12-033 | Other Identifier | Sponsor ID |
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| Name | Class |
|---|---|
| CREATIS Laboratory | UNKNOWN |
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The purpose of this study is to establish on the market and to clinically evaluate a new strategy of treatment for patients with locally advanced non-small cell lung cancer using deformable repositioning of 4D imaging.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| midP arm | Experimental | Patients treated with midP radiotherapy strategy. |
|
| ITV arm | Active Comparator | Patient treated with radiotherapy ITV strategy |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| mid-position radiation strategy | Radiation | The midP strategy defines the target as the time weighted average tumor position (mid-position) plus an additional margin, computed specifically for each patient, that takes into account the tumor motion in each direction. This strategy can help to safely reduce toxicity while preserving treatment efficacy |
| Measure | Description | Time Frame |
|---|---|---|
| 1 year Progression Free Survival rate | Efficacy evaluation of the midP strategy in comparison with ITV strategy in patient with locally advanced, non-resected NSCL cancer treated with radiotherapy | 1 year |
| Measure | Description | Time Frame |
|---|---|---|
| Local tumor control rate | 1 year and 2 years after the end of irradiation | |
| Overall survival | 1 year and 2 years post irradiation | |
| To determine acute and late pulmonary toxicity in the 2 arms, including respiratory functional exploration |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Line CLAUDE, MD | Centre Léon Bérard, Lyon, FRANCE | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Centre Léon Bérard | Lyon | 69373 | France |
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| ITV | Radiation | The ITV strategy is the conventional one. It consists in defining the target as the volume covering the whole tumor motion. |
|
| Week1; Week 2; Week3; Week4; Week5; Week6; Week7 during the radiation, then 4 weeks, 3 months; 6 months ,one year and 2 years after the irradiation beginning |
| ID | Term |
|---|---|
| D002289 | Carcinoma, Non-Small-Cell Lung |
| ID | Term |
|---|---|
| D002283 | Carcinoma, Bronchogenic |
| D001984 | Bronchial Neoplasms |
| D008175 | Lung 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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