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Prospective, open labelled, phase II, monocenter trial to combine partial surgery resection and protontherapy to management paediatric craniopharyngioma.
This study is phase II prospective, open labelled, phase ii, monocenter. The main objective is to evaluate the fractionated high precision radiotherapy with a dose of 59,5 Gy (1,7 Gy daily, 5 fractions per week).
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Protontherapy | Experimental |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Protontherapy | Radiation | 59,5 Gy (1,7 Gy daily, 5 fractions per week). |
|
| Measure | Description | Time Frame |
|---|---|---|
| local control rate at 3 years of a minimally aggressive surgical resection, followed by fractionated high precision radiotherapy | at 3 years |
| Measure | Description | Time Frame |
|---|---|---|
| visual pathway tolerance according to NCI-CTC v3.0 scale | through study completion, up to 9 years |
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Inclusion Criteria:
Exclusion Criteria:
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| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Institut Curie | Paris | 75005 | France | |||
| Groupe Hospitalier Necker Enfants Malades |
Sponsor will share de-identified data sets. Documents generated under the project will be disseminated in accordance with Institut Curie policies.
Data requests can be submitted starting 9 months after last article publication and will be made accessible for up to 12 months.
Access to trial individual participant data can be requested by qualified researchers engaging in independent scientific research, and will be provided following review and approval of a research proposal and Statistical Analysis Plan (SAP) and execution of a data sharing agreement (DSA
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| ID | Term |
|---|---|
| D003397 | Craniopharyngioma |
| ID | Term |
|---|---|
| D017599 | Neuroectodermal Tumors |
| D009373 | Neoplasms, Germ Cell and Embryonal |
| D009370 | Neoplasms by Histologic Type |
| D009369 | Neoplasms |
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| Paris |
| 75015 |
| France |
| Gustave Roussy | Villejuif | 94800 | France |
| D009380 | Neoplasms, Nerve Tissue |