Thoracic Neoplasms
Conditions
Keywords
Thoracic Neoplasms, Platinum-based chemotherapy, 3-D Conformal Radiotherapy, Chemo-radiotherapy induced lung injury, Chemo-radiotherapy induced esophagus injury
Brief 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.
Detailed 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.
Interventions
RADIATIONThoracic 3-D Conformal Radiotherapy
Thoracic RT tailored for each patient, about 60Gy (NSCLC) or 55Gy (SCLC) with photon energies \>=6MV.
Sponsors
Shanghai Cancer Hospital, China
Study design
Observational model
COHORT
Time perspective
PROSPECTIVE
Eligibility
Sex/Gender
ALL
Age
18 Years to 75 Years
Healthy volunteers
No
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
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| 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 |
Countries
China
Outcome results
None listed