"RETINO 2011" : Conservative treatment of patients with retinoblastoma
试验速览
- 阶段
- 2 期
- 状态
- 招募中
- 入组人数
- 133
- 试验地点
- 27
- 主要终点
- For the 3 studies: ocular preservation (absence of secondary enucleation) and absence of external beam radiotherapy at 18 months.
研究概览
简要总结
Study 1- Conservative treatment of retinobalstoma patients (unilateral group A, B according to age, C according to the age and the vitreous seeding) or bilateral groups A,B and C excluding the bilateral groups D or patients with bilateral macular threat , of intravenous chemotherapy (VP16, carboplatin) followed by chemothermotherapy without laser treatment at day 8. To evaluate the efficacy of the treatment in terms of ocular preservation without external beam radiation for the patients treated by intravenous chemotherapy (VP16, carboplatin) followed by chemothermotherapy decreasing the laser sessions.
Study 2 - Conservative treatment of patients with groups B/C according to the age and vitreous seeding/ group D unilateral or very asymmetric with group D in one eye and the other eye amenable to a local treatment, by intra arterial Melphalan. To evaluate the efficacy of melphalan chemotherapy administered by superselective cathetherization of the ophthalmic artery and combined to local treatments (laser treatment, cryoapplication , I125 radioactive plaques or intravitreal melphalan) in terms of ocular preservation without external beam radiation
Study 3 - Conservative treatments of patients with bilateral group D eyes or on the only remaining eye : 6 cycles of three drugs regimen combined to local treatment from the third cycle. To evaluate the efficacy of chemotherapy and local treatments (laser treatment, cryoapplication, I125 plaques or intra vitreal melphalan) in terms of ocular preservation without external beam radiation.
研究设计
- 研究类型
- Interventional
入排标准
- 年龄范围
- 0 years 至 17 years（0-17 Years）
- 接受健康志愿者
- 否
入选标准
- •Overall study inclusion criteria: Patients not previously treated by chemotherapy or radiotherapy for this tumour or another cancer.
- •Study 2 inclusion criteria: 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.
- •Study 2 inclusion criteria: 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.
- •Overall study inclusion criteria: Possible long term follow-up.
- •Overall study inclusion criteria: Written informed consent of the parents or the legal representative.
- •Overall study inclusion criteria: Patients having social security cover.
- •Overall study inclusion criteria: No contra-indications to the study treatments.
- •Studies 1 and 3 inclusion criteria : Children from 0 to 6 years old.
- •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.
- •Study 1 inclusion criteria : 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.
- •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.
排除标准
- •Overall study non-inclusion criteria: Patients older than 6 years old.
- •Study 1 non-inclusion criteria: 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).
- •Study 1 non-inclusion criteria: 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).
- •Study 1 non-inclusion criteria: 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.
- •Study 1 non-inclusion criteria: 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 non-inclusion criteria: Patients with a unilateral group D (extensive) or B or C or D 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).
- •Study 2 non-inclusion 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 non-inclusion criteria: Patients for whom a local treatment is possible without chemoreduction (tumour smaller than 4 mm, distant from macula and from optic nerve head).
- •Study 3 non-inclusion criteria: 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.
- •Study 3 non-inclusion criteria: 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 treatment at day
- •Overall study non-inclusion criteria: Patients with extraocular retinoblastoma.
- •Overall study non-inclusion criteria: Patients with a disease being a contra-indication to chemotherapy.
- •Overall study non-inclusion criteria: Patients anteriorly treated by chemotherapy.
- •Overall study non-inclusion criteria: Patients anteriorly treated by external beam irradiation.
- •Overall study non-inclusion criteria: Patients anteriorly treated for another cancer.
- •Overall study non-inclusion criteria: Follow-up not possible due to geographic distance from the center or for social or psychological reasons..
- •Overall study non-inclusion criteria: Parents not having accepted the therapeutic strategy after explanations by the investigator.
- •Overall study non-inclusion criteria: Contra-indication to the use of one of the drugs used in the study.
结局指标
主要结局
For the 3 studies: ocular preservation (absence of secondary enucleation) and absence of external beam radiotherapy at 18 months.
For the 3 studies: ocular preservation (absence of secondary enucleation) and absence of external beam radiotherapy at 18 months.
次要结局
- Evaluation or the risk of relapse by fundus examination under general anaesthesia until the age of 4 then without general anaesthesia.
- Prospective evaluation of the ocular and general side effects (short, medium and long term) of the intravenous chemotherapy, intra-arterial chemotherapy, combined to the local treatment as well as the intra-vitreal injections of melphalan.
- Evaluation of the response to intra-vitreal chemotherapy by melphalan.
- Study of the radiation doses received during intra-arterial procedures.
- Evaluate the number of patients presenting with another tumour.
研究者
Livia LUMBROSO
Scientific
Institut Curie