Clinical, Biochemical, Dosimetric and Functional Respiratory Predictors of Radiation Pneumonitis in Locally Advanced Lung Cancer (Stages IIIa and IIIb) Treated With Chemotherapy and Radiotherapy
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 发起方
- 入组人数
- 62
- 试验地点
- 1
- 主要终点
- Evaluate pulmonary function after chemoradiation treatment in locally advanced NSCLC patients.
研究概览
简要总结
Lung cancer [LC] is the leading cause of cancer death worldwide. The standard treatment of locally advanced lung cancer unresectable or marginally resectable is combination therapy with radical or preoperative chemoradiation. The local control rates and survival with this treatment modality have increased by more than 30%. Radiotherapy [RT] with technical molded 3D [3D-CRT, Three-Dimensional Conformal Radiation Therapy] or IMRT [intensity-modulated radiation therapy] has allowed that the total dose of radiation has increased which leads to a direct benefit on the results treatment.
Between 17-30% of patients are susceptible to pneumonitis due to radiation [NR]. This complication may appear at the end of the RT or up to 6 months after the treatment. In severe cases, mortality can reach 50%.
It's well known that in various diseases, functional abnormalities precede the clinical manifestations. The degree of pulmonary failure secondary to RT is measured following the standards of the Radiation Therapy Oncology Group who ranks in degrees [0 to 4].
Not precisely known factors that influence the development of NR.
详细描述
Objectives:
To evaluate the effect of chemotherapy and thoracic radiotherapy on pulmonary function and identify predictors of radiation pneumonitis in locally advanced lung cancer [stages IIIA and IIIB].
Hypothesis
Respiratory function tests may predict the development of radiation pneumonitis in patients with locally advanced lung cancer who receive radical treatment with chemoradiation.
Methods Prospective cohort study with patients with locally advanced lung cancer of the Lung Cancer Clinic of the National Cancer Institute [INCAN]. Patients will receive weekly paclitaxel 50 mg and carboplatin AUC 2 with concomitant radiotherapy 44-63 Gy (22-33 fractions). Followup of lung function tests at baseline, during treatment with radiotherapy and will be carried out on 4 more occasions.
研究设计
- 研究类型
- Observational
- 观察模型
- Cohort
- 时间视角
- Prospective
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
- •Candidates must have understood and signed informed consent
- •Histopathological diagnosis of locally advanced lung cancer [IIIA-cT2N1-2, cT3N1-2, cT4N0, M0o IIIB: cT2N3, cT3N3, cT4N1-3, M0]. They may also include patients with oligometastatic disease[M1] candidates for chemoradiation
- •Any histology
- •Medical tests: white blood cell count ≥ plasma 3,000 / mm3, platelets ≥ 100,000 / mm 3, hemoglobin ≥ 12 g / dl, serum creatinine ≤ 1.5 mg / dl, total bilirubin ≤ 1.5, transaminases [ ≤ 2.5 times the upper limit of normal [ULN], alkaline phosphatase <5 ULN.
- •Age ≥ 18 years.
- •General condition score according to ECOG 0 to 2 or a ≥ 60% Karnofsky.
- •Estimated life expectancy with treatment of at least 24 weeks.
- •Exclusion criteria:
- •Uncontrolled concurrent diseases.
- •History of previous radiotherapy to the primary site.
- •Pregnant or breast-feeding.
- •Use of anticoagulants in therapeutic doses
- •Intercurrent Malignancies, except dormant basal cell carcinoma in skin, carcinoma in situ of the cervix
- •Invasive cancer unless the background was at least 5 years and the disease-free status.
排除标准
- 未提供
结局指标
主要结局
Evaluate pulmonary function after chemoradiation treatment in locally advanced NSCLC patients.
时间窗: January 2012 to December 2014
次要结局
未报告次要终点
研究者
Oscar Gerardo Arrieta Rodríguez MD
Chief of Thoracic Oncology Department
Instituto Nacional de Cancerologia de Mexico