Study on the Biological Prediction Models of Radiation Pneumonitis

Huazhong University of Science and Technology

Status: Enrolling

Conditions: Radiation Pneumonitis

Study type: Observational

Funder types: Other

Identifiers

NCT02490319

TJCC002

Details and patient eligibility

About

Radiation pneumonitis is the most common complication and the major dose-limiting toxicity associated with radiotherapy, which can cause poor quality of life or life-threatening symptoms and might hinder the tumor-controlling effects of radiotherapy. Consequently, establishing reliable predictors for the occurrence of RP is of great significance such that the therapeutic effects of RT can be maximized while minimizing its adverse effects. The aim of this study is to figure out the biological prediction models of radiation pneumonitis.

Full description

1. Establish a clinical data base for the lung cancer patients treated with radiotherapy in Tongji Hospital.

   Data including age, gender, smoking state, KPS, pulmonary function, disease history, histology, stage, surgery, chemotherapy, dosimetric parameters of radiotherapy were collected.

   Peripheral blood was collected from all patients enrolled. All patients enrolled in this study are examined during and one month after radiotherapy. Then, the patients are followed every three months for the first year and every six months thereafter. At each follow-up visits, all patients are asked to undergo a chest X-ray or CT and clinical information, including symptoms, is collected. RP is graded by two radiation oncologists according to the Common Terminology Criteria for Adverse Events 4.0.

2. Select candidate genes and pathways which may be associated with radiation pneumonitis and identify their tagSNPs by Haploview.

3. Use Kaplan-Meier and Cox model to analyze the association of all the factors collected with radiation pneumonitis.

4. Establish a biological prediction models for radiation pneumonitis based on the statistics analysis

Enrollment: 300 estimated patients

Sex: All

Ages: 18 to 80 years old

Volunteers: No Healthy Volunteers

Inclusion criteria

1. Clinical diagnosis of lung cancer by histology
2. Radiation dose at least 45 Gy
3. KPS>60
4. Life expectancy of at least 6 months
5. Voluntarily signed the informed consent

Exclusion criteria

1. Previous thoracic irradiation
2. Severe cardiopulmonary diseases

Trial design

300 participants in 1 patient group

Group 1

Description:

Lung cancer patients treated with thoracic radiation therapy