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

The purpose of this study is to evaluate clinical, dosimetrical, functional, biological and genetic factors in predicting chemo-radiotherapy induced lung and esophagus injury.

Study Overview

• Status: Unknown
• Conditions: Thoracic Neoplasms
• Intervention / Treatment: Radiation: Thoracic 3-D Conformal Radiotherapy

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 Type: Observational
• Enrollment (Actual): 140

Contacts and Locations

Study Locations

• China
  • Shanghai, China, 200032
    • Fudan University, Cancer Hospital, Department of Radiation Oncology

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years to 75 years (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

• Sampling Method: Probability Sample

Study Population

Patients enrolled are Chinese with thoracic neoplasms, no distant metastasis and initially treated.

Description

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 Plan

How is the study designed?

Design Details

• Observational Models: Cohort
• Time Perspectives: Prospective

Number of groups / cohorts

1

Cohorts and Interventions

Group / Cohort	Intervention / Treatment
1; 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.	Radiation: Thoracic 3-D Conformal Radiotherapy; Thoracic RT tailored for each patient, about 60Gy (NSCLC) or 55Gy (SCLC) with photon energies >=6MV.; Other Names: Thoracic Radiotherapy(TRT)

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Time Frame
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

Collaborators and Investigators

• Sponsor: Shanghai Cancer Hospital, China
• Investigators: Principal Investigator: Min Fan, MD, Fudan University Cancer Hospital, Department of Radiation Oncology

Study record dates

Study Major Dates

• Study Start: January 1, 2002
• Primary Completion (Actual): January 1, 2006
• Study Completion (Anticipated): October 1, 2008

Study Registration Dates

• First Submitted: March 2, 2008
• First Submitted That Met QC Criteria: March 2, 2008
• First Posted (Estimate): March 10, 2008

Study Record Updates

• Last Update Posted (Estimate): October 7, 2008
• Last Update Submitted That Met QC Criteria: October 6, 2008
• Last Verified: October 1, 2008

More Information

Terms related to this study

• Keywords: Thoracic Neoplasms; Platinum-based chemotherapy; 3-D Conformal Radiotherapy; Chemo-radiotherapy induced lung injury; Chemo-radiotherapy induced esophagus injury
• Additional Relevant MeSH Terms: Neoplasms; Neoplasms by Site; Thoracic Neoplasms
• Other Study ID Numbers: FDCA002

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No
• product manufactured in and exported from the U.S.: No