Clinical trial · Observational
Prospective Study on Factors Predicting Chemo-Radiotherapy Induced Pulmonary and Esophageal Injury
Prospect Study to Evaluate Clinical, Dosimetrical, Functional, Biological and Genetic Factors in Predicting Chemo-Radiotherapy Induced Lung and Esophagus Injury
NCT00631839CI-TRIAL-00001713unknownClinicalTrials.gov clinicaltrialsProvenance
- Source
- ClinicalTrials.gov
- Retrieved
- Sep 8, 2026
- Layer
- normalized (units and labels harmonized; values unchanged)
- Run
- ING-CLINICALTRIALS-20260908-000001
Summary
Brief summary (as posted)
The purpose of this study is to evaluate clinical, dosimetrical, functional, biological and genetic factors in predicting chemo-radiotherapy induced lung and esophagus injury.
Conditions
Conditions (1)
Free-text conditions as registered, with the CancerIndex entity they were reconciled to and the match type.
| Condition (as posted) | Mapped entity | Match | Confidence |
|---|---|---|---|
| Thoracic Neoplasms | Thoracic Neoplasm | ONTOLOGY_EXACT | 0.98 |
Interventions
Interventions (1)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| Thoracic 3-D Conformal Radiotherapy | Radiation | — | UNRESOLVED |
Design
Arms and outcomes
Arms (1)
- label
- 1
- description
- There is only one group in this study. The patients of this group will go through procedures as follow: basic pre-treatment information collected,treatment include platinum-based chemotherapy and 3-D conformal radiotherapy, blood test during RT 6am every Monday and follow-up visits with treatment-induced injury assessed.
- interventionNames
- Radiation: Thoracic 3-D Conformal Radiotherapy
Primary outcomes (1)
- 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
Eligibility
Eligibility (as posted)
- Sex
- All
- Minimum age
- 18 Years
- Maximum age
- 75 Years
Show eligibility criteria text
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
References
Publications (0)
Data not yet available
No reference posted for this study.