Prospective Study on Factors Predicting Chemo-Radiotherapy Induced Pulmonary and Esophageal Injury

• Conditions: Thoracic Neoplasms
• Interventions: Radiation: Thoracic 3-D Conformal Radiotherapy

• Registration Number: NCT00631839
• Lead Sponsor: Shanghai Cancer Hospital, China

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.

Study Timeline

• Study Start: 2002-01
• Primary Completion: 2006-01
• Study First Submitted: 2008-03-02
• Study First Submitted QC: 2008-03-02
• Study First Posted: 2008-03-10
• Status Verified: 2008-10
• Study Completion: 2008-10
• Last Update Submitted: 2008-10-06
• Last Update Posted: 2008-10-07

Recruitment & Eligibility

• Status: UNKNOWN
• Sex: All
• Target Recruitment: 140

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

Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Arm && Interventions

Group	Intervention	Description
1	Thoracic 3-D Conformal Radiotherapy	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.

Primary Outcome Measures

Name	Time	Method
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

Trial Locations

Locations (1)

Fudan University, Cancer Hospital, Department of Radiation Oncology; 🇨🇳 Shanghai, China