Contribution From PET-DOPA in Glioblastoma Re-irradiation - A Randomized Phase II Study
试验速览
- 阶段
- 2 期
- 状态
- 招募中
- 发起方
- 入组人数
- 54
- 试验地点
- 2
- 主要终点
- Efficacy of simultaneous-integrated boost with IMRT guided by FDOPA PET on Recurrence free survival in patient with recurrent glioblastoma
研究概览
简要总结
ReciDOPA is a phase II, single-stage randomized, multicenter, prospective trial assessing the efficacy of an irradiation protocol based on Intensity-modulated radiation therapy with simultaneous-integrated boost guided by FDOPA-PET in patient with recurrent glioblastoma.
详细描述
Glioblastoma (GBM) is the most common cerebral tumor in adults. Despite well-conducted treatments including surgery, chemo-radiotherapy and chemotherapy according to the European Organisation for Research and Treatment of Cancer (EORTC) and National Cancer Institute of Canada Clinical Trials Group (NCIC) protocol, recurrences remain unavoidable within approximately 6 months and the overall survival rate of patients at 5 years is inferior to 10%.
In case of recurrence, a second surgery, radiotherapy under stereotaxic conditions, bevacizumab or other innovative techniques have been proposed. However, they are not yet considered as reference treatments, due to the absence of therapeutic trials definitively proving their efficacy.
Evaluation of GBM progression is based on MRI, corticosteroid intake and clinical status.However, positron emission tomography (PET) is an extremely relevant examination for differentiating between true progression and pseudo-progression. Indeed, an increase in the transfer of amino acids in 18 F-dihydroxyphenylalanine (FDOPA)-PET strongly suggests a recurrence. A local treatment can then be proposed by favoring surgery or, as an option, radiotherapy under stereotactic conditions. However, this treatment, even if it is well tolerated, has an efficacy which could be improved.
Often proposed option to improve efficacy of this radiation technic consists in increasing the dose of irradiation. This dose increase is often limited by the tolerance of nearby healthy tissue. It could however be possible with coupled techniques of intensity modulation and stereotaxy within the framework of an integrated boost (Simultaneous Integrated Boost - SIB). At each radiation session, the dose delivered to the tumor volume would be increased in the metabolic volume (BTV) detected by FDOPA-PET.
The objective of this study is to evaluate, in patients with recurrent glioblastoma, the efficacy of a dose increase using an SIB in a volume delineated with FDOPA-PET.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Treatment
- 盲法
- None
入排标准
- 年龄范围
- 18 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Age > 18 years
- •Glioblastoma, World Health Organization (WHO) grade IV, histologically proven
- •Performance status 0, 1 or 2
- •Neurological status ≥ 2
- •Past irradiation in previsional re-irradiated site or in the vicinity (5 to 7 cm)
- •Radiological proven recurrence according to 1 and 2 criteria, Wen et al
- •Remaining node after partial surgery post-recurrence
- •1 to 3 recurrence site(s) < 35 mm in wide axis and separated by at least 5 mm
- •Volume of each lesion < 35 mL
- •Distance between recurrence node(s) and optic nerves (left and right), chiasma and/or cerebral trunk > 10 mm
排除标准
- •Patient with contraindication to MRI or PET
- •Glioblastomatose
- •Pregnancy or breastfeeding
- •Patient that do not understand French
- •Patient without affiliation to the national or local social security
- •Patients not able to comply to the protocol assessments for geographic, social or psychological reasons
- •Minor or patients placed under guardianship or supervision
- •Patients deprived of liberty
- •Patients placed under judicial protection
- •Patients that are not able to express their consent
研究组 & 干预措施
Simultaneous-integrated boost with Intensity-modulated radiation therapy (IMRT)
- Planning Target Volume (PTV) 37,5 Gray (Gy): 37,5 Gy in 6 fractions of 6,25 Gy at the rate of one fraction each 2 days
- Prescription isodose line (PIL) at 80%, corresponding to 30 Gy as total dose, or 5 Gy per fraction
- PTV SIB 45 Gy: 45,0 Gy in 6 fractions of 7,50 Gy at the rate of one fraction each 2 days
- PIL at 80% corresponding to 36 Gy as total dose, or 6 Gy per fraction
干预措施: Simultaneous-integrated boost with IMRT (Radiation)
Standard IMRT
- PTV 37,5 Gy: 37,5 Gy in 6 fractions of 6,25 Gy at the rate of one fraction each 2 days
- PIL at 80%, corresponding to 30 Gy as total dose, or 5 Gy per fraction
- No SIB
结局指标
主要结局
Efficacy of simultaneous-integrated boost with IMRT guided by FDOPA PET on Recurrence free survival in patient with recurrent glioblastoma
时间窗: up to 24 months
Recurrence free survival: interval between the date of inclusion in the trial until the date of recurrence of irradiated site (or one of the irradiated sites, in case of multiple irradiation)
次要结局
- Characterization of PET parameters at recurrence and compare them to baseline parameters with SUV max value(up to 24 months)
- Characterization of PET parameters at recurrence and compare them to baseline parameters with SUV mean value(up to 24 months)
- Characterization of PET parameters at recurrence and compare them to baseline parameters with SUV peak value(up to 24 months)
- Overall survival(From date of inclusion until the date of death from any cause, assessed up to 72 months)
- Tolerance of re-irradiation(up to 24 months)
- Quality of Life at 12 months measured with Quality of Life Questionnaire-Brain Neoplasms 20items (QLQ-BN20)(At 12 months)
- Percentage of recurrence of irradiated sites(up to 24 months)
- Characterization of recurrence sites: classified either as distant, marginal or in-field(up to 24 months)
- Percentage of Recurrence free survival at 6 months(At 6 months)
- Quality of Life at 6 months measured with Quality of Life Questionnaire-Brain Neoplasms 20items (QLQ-BN20)(At 6 months)
- Quality of Life at 12 months measured with Quality of Life Questionnaire-Cancer 30items (QLQ-C30)(At 12 months)
- Percentage of Recurrence free survival at 12 months(at 12 months)
- Quality of Life at 2 months measured with Quality of Life Questionnaire-Brain Neoplasms 20items (QLQ-BN20)(At 2 months)
- Quality of Life at 4 months measured with Quality of Life Questionnaire-Cancer 30items (QLQ-C30)(At 4 months)
- Quality of Life at 4 months measured with Quality of Life Questionnaire-Brain Neoplasms 20items (QLQ-BN20)(At 4 months)
- Quality of Life at 6 months measured with Quality of Life Questionnaire-Cancer 30items (QLQ-C30)(At 6 months)
- Quality of Life at 2 months measured with Quality of Life Questionnaire-Cancer 30items (QLQ-C30)(At 2 months)