Study on the Biological Prediction Models of Radiation Pneumonitis

Radiation Pneumonitis Clinical Trial

Official title:

Study on the Biological Prediction Models of Radiation Pneumonitis

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT02490319
• Other study ID #: TJCC002
• Status: Recruiting
• Start date: September 2008

Study information

• Verified date: October 2022
• Source: Huazhong University of Science and Technology
• Contact: Xianglin Yuan, MD, PhD
• Phone: 13667241722
• Email: yxl[@]medmail.com.cn
• Is FDA regulated: No
• Study type: Observational

Clinical Trial Summary

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.

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

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 300
• Est. primary completion date: July 2023
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years to 80 Years

Eligibility

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

Related Conditions & MeSH terms

• Pneumonia
• Radiation Pneumonitis

Locations

Country	Name	City	State
China	Department of Oncology, Tongji Hospital	Wuhan	Hubei

Sponsors (1)

Lead Sponsor	Collaborator
Huazhong University of Science and Technology

Country where clinical trial is conducted

China, 

References & Publications (3)

Marks LB, Bentzen SM, Deasy JO, Kong FM, Bradley JD, Vogelius IS, El Naqa I, Hubbs JL, Lebesque JV, Timmerman RD, Martel MK, Jackson A. Radiation dose-volume effects in the lung. Int J Radiat Oncol Biol Phys. 2010 Mar 1;76(3 Suppl):S70-6. doi: 10.1016/j.ijrobp.2009.06.091. Review. — View Citation

Mehta V. Radiation pneumonitis and pulmonary fibrosis in non-small-cell lung cancer: pulmonary function, prediction, and prevention. Int J Radiat Oncol Biol Phys. 2005 Sep 1;63(1):5-24. Review. — View Citation

Yuan X, Liao Z, Liu Z, Wang LE, Tucker SL, Mao L, Wang XS, Martel M, Komaki R, Cox JD, Milas L, Wei Q. Single nucleotide polymorphism at rs1982073:T869C of the TGFbeta 1 gene is associated with the risk of radiation pneumonitis in patients with non-small-cell lung cancer treated with definitive radiotherapy. J Clin Oncol. 2009 Jul 10;27(20):3370-8. doi: 10.1200/JCO.2008.20.6763. Epub 2009 Apr 20. — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	radiation pneumonitis grade >=2 or 3		12 months after radiotherapy