A Phase II Trial of Intensity-Modulated Proton Therapy for Incompletely Resected Craniopharyngioma and Observation for Craniopharyngioma After Radical Resection
试验速览
- 阶段
- 2 期
- 状态
- 进行中（未招募）
- 入组人数
- 160
- 试验地点
- 1
- 主要终点
- Progression-free survival (PFS)
研究概览
简要总结
Craniopharyngioma is a rare brain tumor that affects both children and adults. It arises in a region of the brain near the pituitary gland, visual pathways, and central blood vessels. Patients often present with headache, loss of vision or delayed growth. In some instances they may present with imbalance of water and salts in the body.
The treatment for craniopharyngioma may be radical surgery or a combination of surgery and radiation therapy. In some instances surgery is not required. If the tumor cannot be completely removed, radiation therapy may be required. In this study we will use the most advanced form of proton therapy which is called intensity-modulated proton therapy. This is a newer form of radiation therapy which has a number of advantages over older forms of proton therapy and conventional radiation therapy using x-rays.
The main goal of this study is to learn if proton therapy will effectively treat patients with craniopharyngioma brain tumors and reduce side effects compared to more traditional forms of radiation therapy.
详细描述
This study will include participants who are diagnosed or presumed to have craniopharyngioma based on neuroimaging, intra-operative assessment, or the evaluation of cyst fluid or tissue after limited or radical surgery. When possible, participants will be enrolled on protocol prior to surgery.
PRIMARY OBJECTIVE:
- To estimate the distributions of progression-free and overall survival for children and young adults with craniopharyngioma treated with intensity-modulated proton therapy while monitoring for excessive central nervous system necrosis, clinically significant vasculopathy, and permanent neurological conditions or deficits.
SECONDARY OBJECTIVES:
- To estimate the cumulative incidence of cystic intervention and the event-free survival distribution for children and young adults with craniopharyngioma treated with intensity-modulated proton therapy; and to compare the distributions of progression-free, event-free and overall survival with the distributions for the St. Jude Children's Research Hospital (SJCRH) cohort of patients treated with photon therapy on which the design of this trial is based.
- To estimate the cumulative incidence of cystic intervention and the distributions of progression-free survival, overall survival and the event-free survival for children and young adults with craniopharyngioma treated only with primary surgical resection and to compare these distributions with the distributions observed for patients treated with proton therapy.
研究设计
- 研究类型
- Interventional
- 分配方式
- Non Randomized
- 干预模型
- Parallel
- 主要目的
- Treatment
- 盲法
- None
入排标准
- 年龄范围
- — 至 21 Years（Child, Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Craniopharyngioma diagnosed by histology, cytology or neuroimaging or intra-operative assessment
- •Patients ages 0-21 years at the time of diagnosis
排除标准
- •Prior history of fractionated radiation therapy
- •Prior treatment with intracystic P-32 or intracystic bleomycin
- •Pregnant females are excluded. Radiation has teratogenic or abortifacient effects
研究组 & 干预措施
Tumor-Surgery
Participants who are eligible to undergo surgery to remove the tumor will proceed to surgery. If all tumor is removed, they will be followed over 5 years for outcome comparison to the other participant groups.
If the entire tumor is not removed by surgery, participants will receive 6 weeks of proton therapy. They will then be followed for 5 years to collect outcome data for comparison to the other participant groups.
干预措施: Surgery (Procedure)
Tumor-Surgery
Participants who are eligible to undergo surgery to remove the tumor will proceed to surgery. If all tumor is removed, they will be followed over 5 years for outcome comparison to the other participant groups.
If the entire tumor is not removed by surgery, participants will receive 6 weeks of proton therapy. They will then be followed for 5 years to collect outcome data for comparison to the other participant groups.
干预措施: Proton Therapy (Radiation)
Tumor-No Surgery
Participants whose tumor cannot be resected through surgery will receive 6 weeks of proton therapy. They will then be followed over 5 years for outcome comparison to the other participant groups.
干预措施: Proton Therapy (Radiation)
结局指标
主要结局
Progression-free survival (PFS)
时间窗: 3 years after initiation of proton therapy
PFS is defined as the interval of time from the initiation of radiation therapy (RT) until the earliest of the events: death from any cause; and disease progression.
Overall survival (OS)
时间窗: 3 years after initiation of proton therapy
OS is defined as the interval of time from the initiation of RT until the death from any cause.
次要结局
- Compare incidence of first cystic intervention with participants treated with conventional radiation therapy at St. Jude Children's Research Hospital(3 years after initiation of proton therapy)
- Compare event-free survival (EFS) with participants treated with conventional radiation therapy at St. Jude Children's Research Hospital(3 years after initiation of proton therapy)
- Compare survival distributions between groups(3 years after initiation of proton therapy)
- Compare survival distributions with participants treated with conventional radiation therapy at St. Jude Children's Research Hospital(3 years after initiation of proton therapy)