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Problems of recruitment
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The scope of the trial is to assess the efficacy of the association gemcitabine-cisplatin + radiotherapy followed by an adjuvant chemotherapy
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| patient with cervix cancer | Experimental | will receive gemcitabine + cisplatin + radiotherapy |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Gemcitabine | Drug | 125 mg/m² at day 1, 8, 15, 21 and 28, 2 hours before radiotherapy. |
|
| Measure | Description | Time Frame |
|---|---|---|
| Progression-free survival | 3 years after the end of study treament |
| Measure | Description | Time Frame |
|---|---|---|
| Global survival | 5 years after the end of study treatment | |
| safety | untill 5 years after study treatment |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| BELKACEMI Yazid, MD | Centre Oscar Lambret | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Centre Leonard de Vinci | Dechy | 59187 | France | |||
| Centre Oscar Lambret |
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| ID | Term |
|---|---|
| D002583 | Uterine Cervical Neoplasms |
| ID | Term |
|---|---|
| D014594 | Uterine Neoplasms |
| D005833 | Genital Neoplasms, Female |
| D014565 | Urogenital Neoplasms |
| D009371 | Neoplasms by Site |
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| ID | Term |
|---|---|
| D000093542 | Gemcitabine |
| D011878 | Radiotherapy |
| D002945 | Cisplatin |
| ID | Term |
|---|---|
| D006571 | Heterocyclic Compounds |
| D003841 | Deoxycytidine |
| D003562 | Cytidine |
| D011741 | Pyrimidine Nucleosides |
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| Radiotherapy | Procedure | 45Gy (5 x 1,8Gy/week) on pelvic area +/- boost (10 to 15Gy) +/- 45Gy (5 x 1,8Gy/week)on lumbo-aortic area |
|
| Cisplatin | Drug | 40 mg/m² at day 1, 8, 15, 21 and J28 before Gemcitabine and with a hyperhydration |
|
| Lille |
| 59020 |
| France |
| 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 |
| D011743 |
| Pyrimidines |
| D006573 | Heterocyclic Compounds, 1-Ring |
| D013812 | Therapeutics |
| D017606 | Chlorine Compounds |
| D007287 | Inorganic Chemicals |
| D017672 | Nitrogen Compounds |
| D017671 | Platinum Compounds |