NCT00592748已完成1 期
Randomized Study of Charged Particle RT for Chordomas and Chondrosarcomas of the Base of Skull or Cervical Spine
适应症
试验速览
- 阶段
- 1 期
- 状态
- 已完成
- 入组人数
- 381
- 试验地点
- 2
- 主要终点
- Acute Toxicity
研究概览
简要总结
The primary purpose of this study is to determine if the administration of a higher dose would decrease the chance of tumor recurrence, compared to the risk of tumor recurrence with a lower dose. Most of the treatment will be given protons, but participants may receive a small portion of treatment with x-rays, because less radiation is given to the skin with x-rays. This study uses two slightly different doses of radiation It is not clear at this time which of the dose levels is better.
详细描述
- Participants will be assigned to a dose level by random chance, like flipping a coin.
- A treatment plan will be determined by a treatment planning CT scan and will either involve 40-44 treatments or 37-40 treatments.
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
- •Biopsy proven chordoma. Slides must be reviewed prior to randomization by the central review pathologist
- •Sites: Intercranial (sphenoid, clivus, petrous, basio-occiput) or cervical spine
- •Boost target volume less than or equal to 150
- •18 years of age or older
- •Karnofsky Performance Status > 50
- •Neurologic Function of I or II
- •No evidence of metastases
排除标准
- •Previous radiation to the head or neck that would compromise the ability to deliver the prescribed treatment
- •Concurrent or prior malignancy unless disease free for 5 or more years
- •Evidence of metastatic disease
- •Diabetes mellitus
- •Major medical illness or psychiatric impairments that in the opinion of the investigator, will prevent administration or completion of the protocol therapy
结局指标
主要结局
Acute Toxicity
时间窗: 90 days
次要结局
- Establish local control rates for both dose schedules.(5 years)
- Late Toxicity(5 Years)
- To provide date to be used as the basis for choosing the dose of charged particle radiation for chordomas of the base of skull and the cervical spine.(5 years)
研究者
Norbert J. Liebsch, M.D.
Director, Skull-Based Service
Massachusetts General Hospital
研究点 (2)
Loading locations...
相似试验
招募中
不适用
IMPT Dose Escalation for NSCLC (HyDose)Carcinoma, Non-Small-Cell LungNCT06484491University Medical Center Groningen87
尚未招募
不适用
Effect of Gradually Increasing Force Magnitude on the Rate of Canine Retraction Randomized Controlled TrialCanine RetractionNCT05643443Cairo University17
Unknown
不适用
RECTAL BOOST StudyRectal CancerNCT01951521UMC Utrecht128
终止
4 期
Loading Dose or Standard Dose of Intravenous Ibandronate in Treating Patients With Lung Cancer and Skeletal MetastasisLung CancerNCT00492843Chinese Society of Lung Cancer20
已完成
3 期
Efficacy and Safety Dose Titration Study of Botulinum Toxin Type A to Treat Spasticity in the Leg and ArmSpasticity of the Upper and Lower Limb Due to Cerebral CausesNCT01603459Merz Pharmaceuticals GmbH155