Phase I/II Study of Evaluating the Safety and Efficacy of Using a Simultaneous Integrated Boost for Dose Escalation in Patients With Esophageal Cancer
试验速览
- 阶段
- 1 期
- 状态
- 已完成
- 入组人数
- 61
- 试验地点
- 2
- 主要终点
- Maximum Tolerated Dose (MTD) of Simultaneous Integrated Boost (SIB)
研究概览
简要总结
The goal of this clinical research study is to find the highest tolerable dose of radiation that can be given in combination with chemotherapy in patients with esophageal cancer that cannot be removed by surgery.
详细描述
Radiation Therapy:
If you are found to be eligible, you will receive radiation therapy 5 days for 5 weeks. On Week 6, you will receive radiation therapy on 3 days. You will be assigned to a dose level of radiation based on when you join this study. Up to 2 dose levels of radiation will be tested. The first group of participants will receive the lower dose level. The next group will receive a higher dose than the group before it, if no intolerable side effects were seen.
Chemotherapy Administration:
Your medical oncologist and or his/her team will review and discuss all aspects of chemotherapy administration including drugs you will receive, schedule of chemotherapy, and their side effects with you before starting treatment.
Your study doctor may adjust your chemotherapy dose if you experience intolerable side effects.
研究设计
- 研究类型
- Interventional
- 分配方式
- Na
- 干预模型
- Single Group
- 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
- •Histologically confirmed primary (non-recurrent) adenocarcinoma (AC) or squamous cell carcinoma of the esophagus or AC of the gastroesophageal (GE) junction.
- •Patients must be deemed unresectable disease or considered for a selective surgical approach (where surgery is delay if a patient achieves a complete response) as determined by the multidisciplinary evaluation or patient is not considered operable due to medical reasons.
- •Patients with distant metastasis and life expectancy >/= 3 months are eligible.
- •ECOG Performance Status 0-2
- •No prior radiation to the thorax that would overlap with the current treatment field, prior radiation to other areas is allowed.
- •Patients with nodal involvement are eligible
- •Adequate bone marrow, and renal functions as assessed by the following: Hemoglobin >/= 9.0 g/dl, Platelet count >/= 100,000/mm^3, Creatinine </=1.5 times ULN
- •Ability to understand and the willingness to sign a written informed consent. A signed informed consent must be obtained prior to any study specific procedures.
- •Patients (men and women) of childbearing potential must use effective method of birth control throughout their participation in this study.
- •Induction chemotherapy is allowed.
排除标准
- •Patients with T1, N0 lesions.
- •Patients with a TE fistula or direct invasion into the mucosa of the trachea or major bronchi. Bronchoscopy is encouraged if a TE fistula is suspected. The presence of a fistula will exclude a patient from this study.
- •Prior surgery or radiotherapy for esophageal or gastroesophageal junction cancer.
- •Prior radiotherapy that would overlap the anticipated study treatment fields.
- •Patients with active second malignancy are allowed as long as it is determined that the treatment of esophageal cancer is a higher priority through proper subspecialty consultations.
- •Uncontrolled concurrent illness including, but not limited to: serious uncontrolled infection, symptomatic congestive heart failure (CHF), unstable angina pectoris, or psychiatric illness/social situations that would limit compliance with the study requirements.
- •Known hypersensitivity to docetaxel, 5-FU.
- •Any other condition or circumstance that would, in the opinion of the Investigator, make the patient unsuitable for participation in the study.
结局指标
主要结局
Maximum Tolerated Dose (MTD) of Simultaneous Integrated Boost (SIB)
时间窗: 8 Weeks
MDT defined as CTCAE 3 grade 3 acute radiation toxicity of esophagitis 2 weeks after completion of 6 weeks of radiation therapy.
次要结局
- Pathologic Response(2 months after radiation therapy)
- Time to Local Failure(1 year)