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| ID | Type | Description | Link |
|---|---|---|---|
| 2012-001213-16 | EudraCT Number | ||
| A121007-71 | Registry Identifier | French National Health |
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The purpose of this study is to assess efficacy and tolerance of intra-hepatic administration of Yttrium 90-labelled microsphere (Theraspheres®, Nordion) in association with intravenous chemotherapy with Gemcitabin and Cisplatin for the treatment of intra-hepatic cholangiocarcinoma.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Therasphere® | Experimental | Therasphere® in association with Gemcitabine and Cisplatin |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Therasphere® in association with Gemcitabine and Cisplatin | Radiation | Therasphere® is a radioelement |
|
| Measure | Description | Time Frame |
|---|---|---|
| Radiological response rate to the treatment with the association of chemotherapy and radioembolization | Evaluation according RECIST 1.1 criteria. Rate will be reassessed every 8 weeks | 3 months after radioembolization |
| Measure | Description | Time Frame |
|---|---|---|
| Tolerance of intra-hepatic administration of Yttrium 90-labelled microspheres in association with intravenous chemotherapy with Gemcitabine and Cisplatin assessed according NCI/CTC AE version 4. | Grade 3-4 toxicity appearance.Time between 1st treatment administration and date of 1st appearance of a grade 3-4 toxicity or date of last toxicities assessment in case no grade 3-4 toxicity | Up to 24 months |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Eveline Boucher, MD | Centre Eugene Marquis | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Hôpital Beaujon - Service de Chirurgie | Clichy | 92118 | France | |||
| Hôpital Henri Mondor |
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| Tumor markers changes (CA19.9, CEA and AFP) | Markers will be analysed every 8 weeks during treatment period and if applicable every 12 weeks after surgery | Up to 24 months |
| Radiological response rate by the CHOI criteria | every 8 weeks and every 12 weeks after surgery if applicable | Up to 24 months |
| Change in metabolic activity measured by TEP | Change from baseline in metabolic activity 15 and 24 weeks after last treatment by microspheres |
| Changes of liver volume | Every 8 weeks during treatment and every 12 weeks after surgery if applicable | Up to 24 months |
| Tumoral and non-tumoral dosimetric assessment of the liver | Data obtained from SPECT/CT performed at each hepatic scintigraphy | Up to 6 months |
| Créteil |
| 94010 |
| France |
| Hôpital saint-Eloi | Montpellier | 34295 | France |
| CHU Nancy - Hôpital Brabois | Nancy | 54000 | France |
| CHU- Hotel Dieu | Nantes | 44093 | France |
| CHU Poitiers | Poitiers | France |
| Centre Eugene Marquis | Rennes | 35042 | France |
| ID | Term |
|---|---|
| D018281 | Cholangiocarcinoma |
| ID | Term |
|---|---|
| D000230 | Adenocarcinoma |
| D002277 | Carcinoma |
| D009375 | Neoplasms, Glandular and Epithelial |
| D009370 | Neoplasms by Histologic Type |
| D009369 | Neoplasms |
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| ID | Term |
|---|---|
| D001244 | Association |
| D000093542 | Gemcitabine |
| D002945 | Cisplatin |
| ID | Term |
|---|---|
| D013811 | Psychotherapeutic Processes |
| D011613 | Psychotherapy |
| D004191 | Behavioral Disciplines and Activities |
| D006571 | Heterocyclic Compounds |
| D003841 | Deoxycytidine |
| D003562 | Cytidine |
| D011741 | Pyrimidine Nucleosides |
| D011743 | Pyrimidines |
| D006573 | Heterocyclic Compounds, 1-Ring |
| D017606 | Chlorine Compounds |
| D007287 | Inorganic Chemicals |
| D017672 | Nitrogen Compounds |
| D017671 | Platinum Compounds |
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