Prospective Study on Factors Predicting Chemo-Radiotherapy Induced Pulmonary and Esophageal Injury

Thoracic Neoplasms Clinical Trial

Official title:

Prospect Study to Evaluate Clinical, Dosimetrical, Functional, Biological and Genetic Factors in Predicting Chemo-Radiotherapy Induced Lung and Esophagus Injury

Clinical Trial Details — Status: Active, not recruiting

Administrative data

• NCT number: NCT00631839
• Other study ID #: FDCA002
• Status: Active, not recruiting
• Phase: N/A
• First received: March 2, 2008
• Last updated: October 6, 2008
• Start date: January 2002
• Est. completion date: October 2008

Study information

• Verified date: October 2008
• Source: Shanghai Cancer Hospital, China
• Contact: n/a
• Is FDA regulated: No
• Health authority: China: Ethics Committee
• Study type: Observational

Clinical Trial Summary

The purpose of this study is to evaluate clinical, dosimetrical, functional, biological and genetic factors in predicting chemo-radiotherapy induced lung and esophagus injury.

Description:

We propose a prospective study to investigate the combinational effect of radiotherapeutic dosimetric parameters [mean lung dose and percentage of lung volume receiving at least XGy (Vx)] and biological parameters [interleukin-1α(IL1α),interleukin-1β(IL1β),interleukin-6(IL6),interleukin-7(IL7),transforming growth factor beta (TGFB)] and manganese superoxide dismutase(MnSOD) in predicting radiation pneumonitis, fibrosis, and radiation esophageal injury. Eligibility included pathological or cytological proven thoracic cancer,ECOG performance status [PS] 0-2, no prior thoracic RT or chemotherapy,no distant metastasis and signed informed consent prior to study entry.

Basic pre-treatment information will be collected, which included ECOG PS, UICC/AJCC stage,primary lesion site, history of smoking/coexisting lung disease/surgical resection, and pulmonary function test of FEV1/VC/DLCO. Computed tomography [CT] of the whole lung in treatment position. Blood test of IL1α,IL1β,IL6,IL7,TGFB and MnSOD by ELISA will be done before and weekly during RT. RT must be given by photon energies >=6MV. Radiation lung and esophageal injury will be assessed according to common toxicity criteria adverse effect version3.0 [CTCAE-3.0] during RT and in every follow up visits. Genomic DNA is obtained from the blood drawn during RT. Chi-square test, T test, analysis of variance, logistic regression, and proportional hazard ratio method will be used to investigate whether the parameter(s) can be effective in predicting radiation related sequelae.

Recruitment information / eligibility

• Status: Active, not recruiting
• Enrollment: 140
• Est. completion date: October 2008
• Est. primary completion date: January 2006
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years to 75 Years

Eligibility

Inclusion Criteria:

• Non-pregnant adults (18<= age <= 75 y/o)

• Chinese ethnicity

• Pathological or cytological proven thoracic neoplasms (of note,sputum cytology alone is not acceptable.Cytological specimens obtained by brushing,washing and needle aspiration of a defined lesion are acceptable)

• Initially treated

• No distant metastasis

• ECOG PS 0-2 (Karnofsky>60%)

• Understand and willing to sign the consent

• Normal organ and marrow function as defined below:

• Leukocytes >=3,000/µL

• Haemoglobin >=9 g/dL (prior to transfusions)

• Absolute neutrophil count >=1,500/µL

• Platelets >=100,000/µL

• Total bilirubin < 1.5 x upper limit of normal

• AST (SGOT)/ALT (SGPT) =2.5 X institutional upper limit of normal

• Creatinine <=2.5 mg/dl.

Exclusion Criteria:

• Prior thoracic radiotherapy

• Distant metastasis

• Allergic reactions attributed to compounds of similar chemical or biologic composition to platinum-based drugs.

• Pre-existed non-oncological pulmonary or esophageal disease that may put the patient at high risk of severe toxicities.

• Other uncontrolled intercurrent illness including, but not limited to, ongoing or active infection and psychiatric illness/social situations that would limit compliance with study requirement

• pregnancy or lactating

• Receiving other investigational agents or devices

Study Design

Observational Model: Cohort, Time Perspective: Prospective

Related Conditions & MeSH terms

• Thoracic Neoplasms

Intervention

Radiation:
• Thoracic 3-D Conformal Radiotherapy
Thoracic RT tailored for each patient, about 60Gy (NSCLC) or 55Gy (SCLC) with photon energies >=6MV.

Locations

Country	Name	City	State
China	Fudan University, Cancer Hospital, Department of Radiation Oncology	Shanghai

Sponsors (1)

Lead Sponsor	Collaborator
Shanghai Cancer Hospital, China

Country where clinical trial is conducted

China, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Chemo-Radiotherapy induced pneumonitis,fibrosis and esophagus injury assessed with common toxicity criteria adverse effect version3.0 [CTCAE-3.0]		from the begining of treatment to the end of follow-up	Yes