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This prospective phase II trial study aims to optimize the increase in dose to the target volume at high risk (85 to 90 Gy over 90% of its volume) and the intermediate target volume (60 Gy to 90 % of its volume) in 3D Pulsed Dose Rate Brachytherapy in treating patients with locally advanced cervical cancer.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| ARM A | Experimental | Dose Optimization in 3D Pulsed Dose Rate Brachytherapy |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| External Beam Radiation Therapy | Radiation | 45 Gy pelvis / 25 fr |
|
| Measure | Description | Time Frame |
|---|---|---|
| Increase the local control rate | Increasing local control in two years (from 71.0% to 86.7%) will be achieved by increasing the dose to the target volume (CTV and CTV-HR-RI) measured dose volume histograms | 24 months |
| Measure | Description | Time Frame |
|---|---|---|
| Maintain the cumulative rate grade III and IV complications below 6.5% | 24 months | |
| Relationship between the doses delivered to the target volume and local control | 24 months | |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| PEIFFERT Didier | Institut de Cancérologie de Lorraine | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| CHU de Besançon | Besançon | 25030 | France | |||
| Institut Bergonié |
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| PDR Brachytherapy | Radiation | 1 puls/hour ; 12 Gy / day |
|
| Cisplatin | Drug | increase in dose to the target volume at high risk (85 to 90 Gy over 90% of its volume) and the intermediate target volume (60 Gy to 90 % of its volume) in 3D Pulsed Dose Rate Brachytherapy |
|
|
| Relationship between the doses delivered to the critical organs and rate of grade III and IV complications |
| 24 months |
| Bordeaux |
| 33076 |
| France |
| Centre Georges-François Leclerc | Dijon | 21079 | France |
| Centre Léon Bérard | Lyon | 69373 | France |
| Centre Val d'Aurelle | Montpellier | 34298 | France |
| Centre Paul Strauss | Strasbourg | 67065 | France |
| Centre Claudius Regaud | Toulouse | 31052 | France |
| CHRU Tours - Hôpital Bretonneau | Tours | 37044 | France |
| Institut de Cancérologie de Lorraine | Vandœuvre-lès-Nancy | 54519 | France |
| ID | Term |
|---|---|
| D002583 | Uterine Cervical Neoplasms |
| ID | Term |
|---|---|
| D014594 | Uterine Neoplasms |
| D005833 | Genital Neoplasms, Female |
| D014565 | Urogenital Neoplasms |
| D009371 | Neoplasms by Site |
| D009369 | Neoplasms |
| D002577 | Uterine Cervical Diseases |
| D014591 | Uterine Diseases |
| D005831 | Genital Diseases, Female |
| D052776 | Female Urogenital Diseases |
| D005261 | Female Urogenital Diseases and Pregnancy Complications |
| D000091642 | Urogenital Diseases |
| D000091662 | Genital Diseases |
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| ID | Term |
|---|---|
| D002945 | Cisplatin |
| ID | Term |
|---|---|
| D017606 | Chlorine Compounds |
| D007287 | Inorganic Chemicals |
| D017672 | Nitrogen Compounds |
| D017671 | Platinum Compounds |
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