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

18 Years
75 Years
Open (Enrolling)
Thoracic Neoplasms

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Trial Information

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

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.

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

Type of Study:


Study Design:

Observational Model: Cohort, Time Perspective: Prospective

Outcome Measure:

Chemo-Radiotherapy induced pneumonitis,fibrosis and esophagus injury assessed with common toxicity criteria adverse effect version3.0 [CTCAE-3.0]

Outcome Time Frame:

from the begining of treatment to the end of follow-up

Safety Issue:


Principal Investigator

Min Fan, MD

Investigator Role:

Principal Investigator

Investigator Affiliation:

Fudan University Cancer Hospital, Department of Radiation Oncology


China: Ethics Committee

Study ID:




Start Date:

January 2002

Completion Date:

October 2008

Related Keywords:

  • Thoracic Neoplasms
  • Thoracic Neoplasms
  • Platinum-based chemotherapy
  • 3-D Conformal Radiotherapy
  • Chemo-radiotherapy induced lung injury
  • Chemo-radiotherapy induced esophagus injury
  • Neoplasms
  • Thoracic Neoplasms