NCT02866136Fut, nem toboroz2. fázis
Conservative Treatments of Retinoblastoma
Forrás: ClinicalTrials.gov · Utoljára frissítve: 2025. nov. 24.
Rövid összefoglaló (regiszter, angolul)
Conservative treatments of retinoblastoma (RETINO 2011) 1. -Multicentric non randomised, phase II study for the patients treated by chemoreduction (VP16, carboplatin) followed by chemothermotherapy without laser treatment at day 8 2. -Multicentric non randomised, phase II study for the patients with bilateral very asymmetric dis-ease (Group D eye on one of the eye) or unilateral presentation groups B/C/D according to the age and vitreous seeding 3. \- Multicentric non randomised, phase II study for the patients treated by 6 cycles of three drugs regimen and local treatments for bilateral group D eyes or on the only eye.
- Állapot (regiszter)
- Fut, nem toboroz
- Fázis (regiszter)
- 2. fázis
- Vizsgálattípus
- Beavatkozással járó
- Résztvevők száma
- 133 (tervezett)
- Első benyújtás
- 2016. júl. 27.
- Kezdés
- 2012. febr.
- Elsődleges befejezés
- 2023. jan.
- Fő szponzor
- Institut Curie
- Betegségek
- Gyermekkori daganatok
- NCT-szám
- NCT02866136
Mit vállalsz
- Vizsgálat típusa: Beavatkozással járó · 2. fázis
- Tervezett résztvevők: 133
- 2012. febr. és az elsődleges befejezés (2023. jan.) között
- 1 helyszín, 1 országban
- Vizitek és vizsgálatok: kérdezd a vizsgálat csapatát, a regiszter nem sorolja fel őket
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Korábbi kezelés
- Patients for whom a local treatment is possible without initial chemotherapy (tumour smaller than 4 mm and located far from optic nerve head or macula).
- Patients with an unilateral group D with massive tumour or group E eyes needing enucleation first line or after initial chemotherapy (in case of buphthalmia or suspected optic nerve invasion or extrascleral extension).
- Patients affected by bilateral retinoblastoma very asymmetric with a group D eye that can be treated by intraarterial chemotherapy by Melphalan and the other amenable to local treatments without chemotherapy.
- Patients with bilateral retinoblastoma and bilateral group D eyes or on the only remaining eye or presenting a bilateral macular threat requiring conservative treatment by a 6 cycles, three drugs regimen.
- Study 2 exclusion criteria:
- Patients with a unilateral group D (extensive) or B or C but covering the optic nerve head or group E eyes for which enucleation is warranted first line or after chemotherapy (in case of buphthalmia or suspected optic nerve invasion or extrascleral extension).
- Patients affected by bilateral retinoblastoma very asymmetric with a group D eye that can be treated by intraarterial chemotherapy by Melphalan and the other amenable to local treatments without chemotherapy.
- Patients with bilateral retinoblastoma without macular threat or groups A, B, C than can be treated with chemoreduction by VP16 and Carboplatin then chemothermotherapy without laser at day 8.
- Common exclusion criteria:
- Patients anteriorly treated by chemotherapy.
- Patients anteriorly treated by external beam irradiation.
- Contra-indication to the use of one of the drugs used in the study.
Más betegség
- Patients with a disease being a contra-indication to chemotherapy.
- Patients anteriorly treated for another cancer.
Életkor
- Patients older than 6 years old.
Egyéb
- Study 1 exclusion criteria:
- Patients with unilateral group D eye with tumour volume of more than 50% of eye volume, for whom a massive choroidal invasion could be associated (on clinical or imaging criteria) and for which enucleation is warranted.
- Study 3 exclusion criteria:
- Patients for whom a local treatment is possible without chemoreduction (tumour smaller than 4 mm, distant from macula and from optic nerve head).
- Patients with extraocular retinoblastoma.
- Follow-up not possible due to geographic distance from the center or for social or psychological reasons.
- Parents not having accepted the therapeutic strategy after explanations by the investigator.
Kiket keres a vizsgálat
- Study 1 inclusion criteria:
- Patients affected by unilateral retinoblastoma groups A, B (according to the age), group C (according to the age and vitreous seeding),or bilateral retinoblastoma groups A, B, C (excluding the eyes with macular threat and bilateral group D eyes or on the only remaining eye) amenable to a conservative treatment (at least on one eye in bilateral disease) but needing initial chemotherapy because of the location, the size of the lesion (more than 4 mm of diameter), a vision threat or risks of intravitreal relapse making those patients not amenable to chemothermotherapy first line.
- Patients less than six months of age with unilateral retinoblastoma groups B, C, D, or bilateral very asymmetric with one eye group D and the other amenable to local treatments without chemotherapy.
- Children from 0 to 6 years old.
- Study 2 inclusion criteria:
- Patients affected by unilateral or bilateral retinoblastoma group B (according to the age), group C (according to the age and vitreous seeding), or group D.
- Patients affected by bilateral retinoblastoma very asymmetric with a group D eye that can be treated by intraarterial chemotherapy by Melphalan and the other amenable to local treatments without chemotherapy.
- Children from 6 months to 6 years old.
- Study 3 inclusion criteria:
- Children affected of bilateral group D retinoblastoma or on the only eye amenable to conservative treatment.
- Children from 0 to 6 years old.
- Common inclusion criteria:
- Patients not previously treated by chemotherapy or radiotherapy for this tumour or another cancer.
- No contra-indications to the study treatments
- Possible long term follow-up.
- Written informed consent of the parents or the legal representative.
- Patients having social security cover.
Életkor a regiszterben: - – 6 év · Nem: nők és férfiak · Egészséges önkénteseket nem fogad
Helyszínek (1)
Helyszínek a regiszter sorrendjében. Ha a profilodba mented a városodat, távolság szerint rendeződnek.
| Helyszín | Város | Ország | Helyszín állapota |
|---|---|---|---|
| Institut Curie Ennek a helyszínnek vagy a koordinátora? Erősítsd meg az állapotát | Paris | Franciaország | Ismeretlen állapot |
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