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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details. Identifier: NCT00631839
Recruitment Status : Unknown
Verified October 2008 by Shanghai Cancer Hospital, China.
Recruitment status was:  Active, not recruiting
First Posted : March 10, 2008
Last Update Posted : October 7, 2008
Information provided by:
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.

Condition or disease Intervention/treatment
Thoracic Neoplasms 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
Actual Enrollment : 140 participants
Observational Model: Cohort
Time Perspective: Prospective
Official Title: Prospect Study to Evaluate Clinical, Dosimetrical, Functional, Biological and Genetic Factors in Predicting Chemo-Radiotherapy Induced Lung and Esophagus Injury
Study Start Date : January 2002
Actual Primary Completion Date : January 2006
Estimated Study Completion Date : October 2008

Group/Cohort Intervention/treatment
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 Name: Thoracic Radiotherapy(TRT)

Primary Outcome Measures :
  1. Chemo-Radiotherapy induced pneumonitis,fibrosis and esophagus injury assessed with common toxicity criteria adverse effect version3.0 [CTCAE-3.0] [ Time Frame: from the begining of treatment to the end of follow-up ]

Biospecimen Retention:   Samples With DNA
Patients' blood samples will be retained for the purpose of cytokine and MnSOD assay and DNA detection. The samples will be left till the study ends. Paitents will have their vein blood drawn from left arm 6am every Monday during RT. All above is stated in informed consent form.

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Ages Eligible for Study:   18 Years to 75 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Sampling Method:   Probability Sample
Study Population
Patients enrolled are Chinese with thoracic neoplasms, no distant metastasis and initially treated.

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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its identifier (NCT number): NCT00631839

Fudan University, Cancer Hospital, Department of Radiation Oncology
Shanghai, China, 200032
Sponsors and Collaborators
Shanghai Cancer Hospital, China
Principal Investigator: Min Fan, MD Fudan University Cancer Hospital, Department of Radiation Oncology

Responsible Party: Fan Min, Associate Professor, Vice Chief of Lung Cancer Center, Fudan University, Shanghai Cancer Hospital, China Identifier: NCT00631839     History of Changes
Other Study ID Numbers: FDCA002
First Posted: March 10, 2008    Key Record Dates
Last Update Posted: October 7, 2008
Last Verified: October 2008

Keywords provided by Shanghai Cancer Hospital, China:
Thoracic Neoplasms
Platinum-based chemotherapy
3-D Conformal Radiotherapy
Chemo-radiotherapy induced lung injury
Chemo-radiotherapy induced esophagus injury

Additional relevant MeSH terms:
Thoracic Neoplasms
Neoplasms by Site