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临床试验/NCT02841228
NCT02841228Unknown2 期

Intensity-modulated Radiotherapy (IMRT) With Simultaneous Integrated Boost (SIB) Dose Escalation to the Gross Tumor Volume (GTV) With Concurrent Chemotherapy for Stage II/III Non-small Cell Lung Cancer (NSCLC)

Hunan Province Tumor Hospital1 个研究点 分布在 1 个国家目标入组 40 人开始时间: 2015年11月1日最近更新:
适应症
干预措施

试验速览

阶段
2 期
发起方
入组人数
40
试验地点
1
主要终点
Progression free survival (PFS)

研究概览

简要总结

Lung cancer is one of the most common cancer and the leading causes of cancer death in worldwide. Approximately 80% of NSCLC were inoperable. The prognosis of patients with LA-NSCLC remains disappointing. Investigators hypothesized that use of simultaneous integrated boost intensity modulated radiotherapy (SIB-IMRT) technology can safety increasing the radiation dose and benefit for inoperable NSCLC patients.

详细描述

Lung cancer is one of the most common cancer and the leading causes of cancer death in patients worldwide. Approximately 80% of NSCLC were inoperable. Concurrent chemo-radiation therapy (CCRT) is a standard treatment for locally advanced NSCLC who are not candidates for surgery. Nevertheless, the prognosis of patients with locally advanced NSCLC (LA-NSCLC) is still poor. Local control (LC) after CCRT is one of the most important prognostic factors. Local failure is common after standard-dose chemoradiation for NSCLC. Studies of stereotactic body radiation therapy (SBRT) have shown a steep dose response in treating early-stage lung cancer. Improving the total dose and shortening the overall treatment time may be effective for improving the LC rates. However, problems remain due to the toxicity to adjacent critical structures (e.g,lung,heart, esophagus), the target volumes usually limits the doses escalated that cannot be safely delivered by conventional radiotherapy techniques. In order to avoid the acute and late radiation toxicity of normal tissues, different dose prescriptions can be delivered to different target volumes in the same fraction, which deliver a higher dose to the Gross Tumor Volume (GTV) and a relatively lower dose to the subclinical disease. The technique is called simultaneous integrated boost intensity modulated radiotherapy (SIB-IMRT).

Investigators hypothesized that use of SIB-IMRT technology can safety increasing the radiation dose and benefit for inoperable NSCLC patients.

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 75 Years(Adult, Older Adult)
性别
All
接受健康志愿者
否

入选标准

  • •Histologically confirmed NSCLC, inoperable stages IIA-IIIB, according to American Joint Committee on Cancer (AJCC)Cancer Stage 7th
  • •Performance status 0 to 2, ≤5% weight loss within the past 6 months
  • •A forced expiratory volume at 1 second of ≥ 1 L
  • •Life expectancy > 3 months
  • •No invasion of large vessels, heart, esophagus, spinal cord.
  • •Based on conformal treatment planning, the volume of lung at or exceeding 20 Gy (V20) must have been≤30%, the mean esophagus dose≤34 Gy, and the volume of esophagus exceeding 55 Gy (V55)≤30%
  • •Tolerable and agree for Intensity-Modulated Radiation Therapy(IMRT) and concurrent chemoradiotherapy
  • •Without severe other diseases
  • •Informed consent

排除标准

  • •Had received prior thoracic radiotherapy
  • •Supraclavicular lymph node metastasis, pleural or pericardial effusions, and superior vena cava syndrome
  • •Pregnant and lactating women
  • •Serious complications
  • •Other primary malignancies

研究组 & 干预措施

IMRT + SIB + Chemotherapy

Experimental

For all patients, the dose to the PTV will be kept constant at 60 Gy in 30 fractions at 2.0 Gy per fraction, SIBV will be kept constant at 72 Gy in 30 fractions at 2.4 Gy per fraction. Fractions given once a day, 5 times a week for six weeks. All patients will receive standard concurrent chemotherapy.

干预措施: IMRT + SIB + Chemotherapy (Radiation)

结局指标

主要结局

Progression free survival (PFS)

时间窗: up to 12 months

Progression free survival is defined as the time (in months) from the date of admission to the date of progression or last follow-up

次要结局

  • Treatment-related toxicities(up to 6 months)
  • Overall Response Rate (ORR)(up to 3 months)
  • Overall survival (OS)(up to 36 months)

研究者

发起方
Hunan Province Tumor Hospital
申办方类型
Other
责任方
Principal Investigator
主要研究者

Hui Wang

Chief of thoracic radiation oncology department

Hunan Province Tumor Hospital

研究点 (1)

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