Clinical trial NCT00631839: Prospective Study on Factors Predicting Chemo-Radiotherapy Induced Pulmonary and Esophageal Injury
Official title: Prospect Study to Evaluate Clinical, Dosimetrical, Functional, Biological and Genetic Factors in Predicting Chemo-Radiotherapy Induced Lung and Esophagus Injury
Study type: OBSERVATIONAL
Overall status: UNKNOWN
Conditions: Thoracic Neoplasms
Keywords: Thoracic Neoplasms
Platinum-based chemotherapy
3-D Conformal Radiotherapy
Chemo-radiotherapy induced lung injury
Chemo-radiotherapy induced esophagus injury
Lead sponsor: Shanghai Cancer Hospital, China
Sponsor class: OTHER
First posted: 2008-03-10
Enrollment: 140
Sex: ALL
Minimum age (years): 18
Maximum age (years): 75
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: PROBABILITY_SAMPLE
Study population: Patients enrolled are Chinese with thoracic neoplasms, no distant metastasis and initially treated.

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.

Eligibility criteria: 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

Primary outcomes:
measure: Chemo-Radiotherapy induced pneumonitis,fibrosis and esophagus injury assessed with common toxicity criteria adverse effect version3.0 [CTCAE-3.0]
timeFrame: from the begining of treatment to the end of follow-up
Secondary outcomes:
Other outcomes:
Locations:
city: Shanghai
country: China
facility: Fudan University, Cancer Hospital, Department of Radiation Oncology
Study officials:
affiliation: Fudan University Cancer Hospital, Department of Radiation Oncology
name: Min Fan, MD
role: PRINCIPAL_INVESTIGATOR
References: