Status:
UNKNOWN
Prospective Study on Factors Predicting Chemo-Radiotherapy Induced Pulmonary and Esophageal Injury
Lead Sponsor:
Shanghai Cancer Hospital, China
Conditions:
Thoracic Neoplasms
Eligibility:
All Genders
18-75 years
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 biolog...
Eligibility Criteria
Inclusion
- 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
- 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
Key Trial Info
Start Date :
January 1 2002
Trial Type :
OBSERVATIONAL
Allocation :
ACTUAL
End Date :
October 1 2008
Estimated Enrollment :
140 Patients enrolled
Trial Details
Trial ID
NCT00631839
Start Date
January 1 2002
End Date
October 1 2008
Last Update
October 7 2008
Active Locations (1)
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1
Fudan University, Cancer Hospital, Department of Radiation Oncology
Shanghai, China, 200032