Enhanced Local Intensified Radiation Therapy in Elderly Glioblastoma (ELITE-GBM): A Phase 2 Hybrid Randomized Trial Leveraging External Data
试验速览
- 阶段
- 2 期
- 状态
- 招募中
- 入组人数
- 56
- 试验地点
- 3
- 主要终点
- Overall survival
研究概览
简要总结
Glioblastoma (GBM) is an aggressive malignancy of the central nervous system. Older adults with GBM have a unique constellation of medical, psychosocial, and supportive care needs. To address these challenges, prior work has evaluated the feasibility of hypofractionation, a treatment approach delivering fewer, larger radiation dosages over a shorter time period. Common hypofractionated regimens deliver a lower biologically equivalent radiation dose than the conventional regimens used for younger adults. Whether dose escalated hypofractionation can further improve outcomes in older adults remains unclear.
This will be a hybrid randomized control trial comparing the efficacy and safety of dose-escalated and standard hypofractionated radiotherapy among older adults with newly-diagnosed glioblastoma compared to standard three-week course. This research study involves the administration of radiation therapy. Radiation will either be delivered at the standard daily dose or at an increased daily dose over a three weeks course of radiation treatment.
Research study procedures will include a screening evaluation to assess eligibility, as well as clinical visits for radiation delivery and to assess symptoms during treatment and at scheduled follow-up times.
Participants will be randomly assigned to one of the two arms of the trial:
- Standard hypofractionated radiation over 3 weeks
- Dose-escalated hypofractionated radiation over 3 weeks
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
- 65 Years 至 —（Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Histological confirmation of WHO grade 4 glioblastoma (IDH wild-type by immunohistochemistry or sequencing). Histopathology must be confirmed by central review.
- •Newly diagnosed disease, with time elapsed from diagnostic surgery/resection <8 weeks.
- •Age ≥ 65 years old at time of glioblastoma diagnosis
- •Adequate functional status as measured by a ECOG Performance Status 0, 1 or 2, at time of enrollment.
- •Adequate hematological, renal and hepatic functions as defined by the following required laboratory values obtained within 45 days prior to randomization:
- •Platelet count ≥ 100 x 10^9/L (100,000 cells/mm^3) Serum creatinine ≤ 1.5 times the upper limit of normal Total serum bilirubin ≤ 1.5 times the upper limit of normal ALT (SGPT) < 2.5 times the upper limit of normal and/or AST (SGOT) < 2.5 times the upper limit of normal
- •Patient may have received corticosteroids, but must be on a stable or decreasing dose for at least 14 days prior to randomization.
排除标准
- •Participants with recurrent glioma.
- •Participants with evidence of spinal, leptomeningeal, or more distant disease.
- •Participants with another active central nervous system malignancies requiring treatment.
- •Participants with a second invasive malignancy that is A) incompletely treated or requiring ongoing treatment, or B) reasonably anticipated to be associated with a median overall survival of less than 1 year based on population-level data for the specified disease site and stage.
- •Participants with any other major medical illnesses or psychiatric treatments that in the treating physician's opinion will prevent administration or completion of protocol therapy.
- •Participants with inadequate mental capacity to provide informed consent
- •Participants who cannot receive gadolinium
- •Participants who have undergone prior head and neck or cranial radiation or radiation to any other site previously that would be reasonably anticipated to result in a significant overlap in radiation fields.
- •Participants who have received systemic or radiosensitizing therapy for a prior head and neck or central nervous system malignancy or any investigational cancer drug for glioblastoma prior to randomization.
- •Participants who have received or plan to receive any other form of non-surgical local or field treatment overlapping with the anticipated radiation field.
- •Patients with a serious active infection (such as a wound infection requiring parenteral antibiotics) or other acute medical conditions at the time of randomization that would impair the ability of the patient to receive protocol treatment.
研究组 & 干预措施
Dose-escalated hypofractionated radiation over 3 weeks
干预措施: Dose-escalated radiation therapy (Radiation)
Standard hypofractionated radiation over 3 weeks
干预措施: Standard hypofractionated radiation (Radiation)
结局指标
主要结局
Overall survival
时间窗: Overall survival from time of enrollment through study completion, an average of 1 year
through study completion, an average of 1 year
次要结局
- Progression-free survival(Time of enrollment to time of progressionfrom time of enrollment through study completion, an average of 6 months)
- Treatment-related toxicity(Time of enrollment to end of treatment (upto 6 months after completion of radiation therapy))
- Health-related quality of life(From time of enrollment upto 6 months later)
- Mood symptoms(From time of enrollment upto 6 months later)
- Practical Geriatric Assessment(From time of enrollment upto 6 months later)
- Performance status(From time of enrollment upto 6 months later)
研究者
Rifaquat M. Rahman, MD
Assistant Professor
Brigham and Women's Hospital