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

NCT ID: NCT00631839

Last Updated: 2008-10-07

Basic Information

• Recruitment Status: UNKNOWN
• Total Enrollment: 140 participants
• Study Classification: OBSERVATIONAL
• Study Start Date: 2002-01-31
• Study Completion Date: 2008-10-31

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.

Conditions

Thoracic Neoplasms

Keywords

Thoracic Neoplasms; Platinum-based chemotherapy; 3-D Conformal Radiotherapy; Chemo-radiotherapy induced lung injury; Chemo-radiotherapy induced esophagus injury

Study Design

• Observational Model Type: COHORT
• Study Time Perspective: PROSPECTIVE

Study Groups

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.

Thoracic 3-D Conformal Radiotherapy

Intervention Type: RADIATION

Thoracic RT tailored for each patient, about 60Gy (NSCLC) or 55Gy (SCLC) with photon energies \>=6MV.

Interventions

Thoracic 3-D Conformal Radiotherapy

Thoracic RT tailored for each patient, about 60Gy (NSCLC) or 55Gy (SCLC) with photon energies \>=6MV.

Intervention Type: RADIATION

Other Intervention Names

Thoracic Radiotherapy(TRT)

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

• Minimum Eligible Age: 18 Years
• Maximum Eligible Age: 75 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Shanghai Cancer Hospital, China

OTHER

Sponsor Role: lead

Responsible Party

Shanghai Cancer Hospital, China

Principal Investigators

Min Fan, MD

Role: PRINCIPAL_INVESTIGATOR

Fudan University Cancer Hospital, Department of Radiation Oncology

Locations

Fudan University, Cancer Hospital, Department of Radiation Oncology

Shanghai, , China

Countries

China

Other Identifiers

FDCA002

Identifier Type: -

Identifier Source: org_study_id