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| ID | Type | Description | Link |
|---|---|---|---|
| 02 GENM 02 |
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The purpose of this study is to determine whether association Gemcitabine-Cisplatin is effective in the treatment of penis epidermoid carcinoma loco-regionally advanced or metastatic.
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| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Gemcitabine | Drug | Gemzar IV infusion 30 minutes Day 1/ Day 15 1250 mg/m²/j | ||
| Cisplatin | Drug | Cisplatin 50 mg/m²/day 1 h IV infusion at Day 1 / Day 15 |
| Measure | Description | Time Frame |
|---|---|---|
| To evaluate objective response rate | until desease progression |
| Measure | Description | Time Frame |
|---|---|---|
| To evaluate tolerance of the association, | during all participation of the subject | |
| time to progression, | untill progression | |
| global survival |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Christine Chevreau, Doctor | Institut Claudius Regaud | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Centre Paul Papin | Angers | France | ||||
| Institut Bergonie |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 25601543 | Result | Houede N, Dupuy L, Flechon A, Beuzeboc P, Gravis G, Laguerre B, Theodore C, Culine S, Filleron T, Chevreau C. Intermediate analysis of a phase II trial assessing gemcitabine and cisplatin in locoregional or metastatic penile squamous cell carcinoma. BJU Int. 2016 Mar;117(3):444-9. doi: 10.1111/bju.13054. Epub 2015 Apr 27. |
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| ID | Term |
|---|---|
| D005834 | Genital Neoplasms, Male |
| ID | Term |
|---|---|
| D014565 | Urogenital Neoplasms |
| D009371 | Neoplasms by Site |
| D009369 | Neoplasms |
| D005832 | Genital Diseases, Male |
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| ID | Term |
|---|---|
| D000093542 | Gemcitabine |
| D002945 | Cisplatin |
| ID | Term |
|---|---|
| D006571 | Heterocyclic Compounds |
| D003841 | Deoxycytidine |
| D003562 | Cytidine |
| D011741 | Pyrimidine Nucleosides |
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| untill death |
| Bordeaux |
| France |
| Centre François Baclesse | Caen | France |
| CHU Grenoble | Grenoble | France |
| Centre Léon Bérard | Lyon | France |
| Institut Paoli Calmette | Marseille | France |
| Institut Val d'aurelle | Montpellier | France |
| Institut Curie | Paris | France |
| Centre Eugène Marquis | Rennes | France |
| Centre Médico-Chirurgical Foch | Suresnes | France |
| Institut Claudius Regaud | Toulouse | France |
| D000091662 |
| Genital Diseases |
| D000091642 | Urogenital Diseases |
| D052801 | Male Urogenital Diseases |
| D011743 |
| Pyrimidines |
| D006573 | Heterocyclic Compounds, 1-Ring |
| D017606 | Chlorine Compounds |
| D007287 | Inorganic Chemicals |
| D017672 | Nitrogen Compounds |
| D017671 | Platinum Compounds |