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| ID | Type | Description | Link |
|---|---|---|---|
| 2007/1297 | Other Identifier | CSET number |
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| Name | Class |
|---|---|
| National Cancer Institute, France | OTHER_GOV |
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The treatment of cervical tumors depends on the stage of the disease. In advanced forms (nodal and / or local extension to the vagina and / or parameters) , radiotherapy associated with curietherapy , plays a major role. Until recently this association was the standard treatment for advanced stage uterine cancer. With this combination, rates of local failures (evolutionary prosecution and local recurrences) were 20 to 50% in stages IIb and 50-75 % for stage III. More than 50% for patients with a cervical cancer locally advanced (FIGO stages II / IV) . The standard treatment, external radiotherapy followed by curietherapy allows expect survival rates at 5 years for approximately 30-45 %. For ten years, numerous studies have evaluated the addition of concurrent chemotherapy to radiotherapy in cancer of the cervix. More than 19 randomized trials have been published. A meta-analysis of these trials was undertaken to assess the role of radiochemotherapy in cancers of the cervix. The first meta-analysis published by the Cochrane Collaborative Group, taking into account 4580 patient, shows an improvement in survival, both in terms of progression free survival and overall survival for patients treated with radio chemotherapy respectively 16% and 12 % (p < 0.0001). The rate of metastasis is also decreased (p < 0.0001). Survival rates were significantly better when platinum salt was used ( p < 0.0001 ) . However, no clinical benefit of chemoradiotherapy has been demonstrated for tumors stages [1, 2] locally advanced, possibly due to small number of patients. The investigators have previously shown that antiviral agents used in preclinical models, CidofovirĀ® causes the selective radiosensitization of cells infected by the papillomavirus (HPV). This trial proposes to study a new concept to increase radiochemotherapy efficiency: the modulation of the expression of viral oncoproteins HPV virus by an antiviral agent.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Radiotherapy + Vistide + Chemoterapy | Experimental |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| External radiotherapy + curietherapy | Radiation | External radiotherapy: 45 Gy in 5 weeks Curietherapy: 15Gy |
|
| Measure | Description | Time Frame |
|---|---|---|
| Dose limiting toxicity | Assessed every week after inclusion up to 10 weeks |
| Measure | Description | Time Frame |
|---|---|---|
| Efficacy Using RECIST criteria | Using RECIST criteria | Assessed 14 weeks after inclusion |
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Inclusion Criteria:
Exclusion Criteria:
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| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Gustave Roussy Cancer Campus Grand Paris | Villejuif | Val de Marne | 94805 | France |
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| Vistide | Drug | VISTIDEĀ® (mg/kg) Level 1: 1mg/kg Level 2: 2,5 mg/kg Level 3: 5 mg/kg Level 4: 6,5 mg/kg |
|
| Carboplatin | Drug | AUC= 2,5 (Calvert formula) |
|
| 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 |
|---|---|
| D001918 | Brachytherapy |
| D000077404 | Cidofovir |
| D016190 | Carboplatin |
| ID | Term |
|---|---|
| D011878 | Radiotherapy |
| D013812 | Therapeutics |
| D063065 | Organophosphonates |
| D009943 | Organophosphorus Compounds |
| D009930 | Organic Chemicals |
| D003596 | Cytosine |
| D011744 | Pyrimidinones |
| D011743 | Pyrimidines |
| D006573 | Heterocyclic Compounds, 1-Ring |
| D006571 | Heterocyclic Compounds |
| D056831 | Coordination Complexes |
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