Pulsed Low Dose Rate Radiation With Concurrent Chemotherapy for Non-Small Cell Lung Cancer and Esophageal Cancer
试验速览
- 阶段
- 1 期
- 状态
- 招募中
- 入组人数
- 40
- 试验地点
- 1
- 主要终点
- Rate of severe acute esophagitis in patients with lung cancer and esophageal cancer treated with concurrent CRT using PLDR technique.
研究概览
简要总结
Phase I study with the hypothesis that Pulsed Low Dose Radiation (PLDR) radiation delivery technique can significantly decrease the rate of severe acute esophagitis in patients receiving concurrent Chemo-radiation therapy (CRT) for non-small cell lung cancer or esophageal cancer while maintaining similar efficacy. For these patients, the rate of severe acute esophagitis during concurrent CRT is high (approximately 20%) when conventional external beam radiation is utilized. Severe acute esophagitis can cause many adverse consequences such as severe discomfort, weight loss, hospitalization, interruption/early termination of treatment, and worse surgical complications for those who receive surgery after CRT. PLDR radiation has the potential to maintain the tumor control rates of conventional radiation while decreasing the toxicity to the surrounding normal tissue 29-35.
We have completed accrual to a phase I PLDR radiation study, in which patient received palliative re-irradiation with PLDR technique for their metastatic disease in previous irradiated field. In that phase I study, PLDR demonstrated safety for acute toxicities in the setting of re-irradiation for a total dose of 50 Gy, with analysis of 60 Gy pending. The follow up time for that phase I study is limited as most enrolled patients have short overall survival due to their terminal illness.
This proposed phase I study is, to our knowledge, the first clinical study with combination of PLDR radiation and concurrent chemotherapy for definitive treatment.
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
- •Patient must have pathologically-confirmed and previously untreated:
- •Non-small cell lung cancer, Stage IIIA (T1-3 N2 M0); OR
- •Localized esophageal cancer, ≥T2, or N+, and M0 according to the American Joint Committee on Cancer (AJCC) 7th edition staging.
- •The planned treatment regimen must be concurrent chemoradiation with Carboplatin-Paclitaxel followed by surgery.
- •Age > 18 years.
- •Eastern Cooperative Oncology Group (ECOG) performance status is 0-
- •Laboratory studies must meet each of the following criteria (with labs drawn within 4 weeks prior to the registration):
- •Absolute neutrophil count (ANC) ≥ 1,500 cells/mm3
- •Platelets ≥100,000 cells/mm3
- •Hemoglobin ≥ 8.0 g/dl (Note: The use of transfusion or other intervention to achieve Hgb ≥ 8.0 g/dl is acceptable)
- •Creatinine ≤2 X the upper limit of normal
- •Bilirubin ≤ 1.5 X upper limit of normal
- •Aspartate transaminase (AST) ≤ 3 X upper limit of normal
- •Men and women of childbearing potential must be willing to exercise an effective form of birth control (abstinence/contraception) while on study and for 3 months after therapy completed.
- •Patients must be able to read and write English to comply with the questionnaire portions of the protocol.
- •Subjects must sign a written informed study consent and HIPAA consent prior to performance of study-specific procedures or assessments and must be willing to comply with treatment and follow up.
排除标准
- •Patients who have had previous radiotherapy in the thorax.
- •Patients who have a history of ataxia telangiectasia or other documented history of radiation hypersensitivity.
- •Patients who have a history scleroderma or other active connective tissue disease.
- •Women of childbearing potential must not be pregnant with a negative urine pregnancy test within 72 hours prior to registration and non-lactating; postmenopausal woman must have been amenorrheic for at least 12 months to be considered of non-childbearing potential; woman status post oophorectomy or hysterectomy are considered non-childbearing potential
- •Patients who have uncontrolled inter-current illness including, but not limited to, psychiatric illness/social situations that would limit compliance with study requirements.
研究组 & 干预措施
Pulsed Low dose radiation with Carboplatin/Paclitaxel
Pulsed Low Dose Radiation concurrent with Carboplatin and Paclitaxel
干预措施: Pulsed Low Dose Radiation (Radiation)
Pulsed Low dose radiation with Carboplatin/Paclitaxel
Pulsed Low Dose Radiation concurrent with Carboplatin and Paclitaxel
干预措施: Carboplatin (Drug)
Pulsed Low dose radiation with Carboplatin/Paclitaxel
Pulsed Low Dose Radiation concurrent with Carboplatin and Paclitaxel
干预措施: Paclitaxel (Drug)
结局指标
主要结局
Rate of severe acute esophagitis in patients with lung cancer and esophageal cancer treated with concurrent CRT using PLDR technique.
时间窗: 2 years
The investigator will evaluate the severity of other adverse events using the NCI Common Terminology Criteria for Adverse Events (CTCAE v.4.0).
次要结局
- Progression free survival(1-5 years)
- Response rate based(1 year)
- Quality of life(1 year)