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

Sponsored by:	Shanghai Cancer Hospital,China
Information provided by:	Shanghai Cancer Hospital,China
ClinicalTrials.gov Identifier:	NCT00631839

Purpose

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	Intervention
Thoracic Neoplasms	Radiation: Thoracic 3-D Conformal Radiotherapy

Study Type:	Observational
Study Design:	Cohort, Prospective
Official Title:	Prospect Study to Evaluate Clinical, Dosimetrical, Functional, Biological and Genetic Factors in Predicting Chemo-Radiotherapy Induced Lung and Esophagus Injury

Resource links provided by NLM:

MedlinePlus related topics: Cancer Radiation Therapy

U.S. FDA Resources

Further study details as provided by Shanghai Cancer Hospital,China:

Primary Outcome Measures:

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 ] [ Designated as safety issue: Yes ]

Biospecimen Retention: Samples With DNA

Biospecimen Description:

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.

Enrollment:	140
Study Start Date:	January 2002
Estimated Study Completion Date:	October 2008
Primary Completion Date:	January 2006 (Final data collection date for primary outcome measure)

Groups/Cohorts	Assigned Interventions
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.

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.

Eligibility

Ages Eligible for Study:	18 Years to 75 Years
Genders Eligible for Study:	Both
Accepts Healthy Volunteers:	No
Sampling Method:	Probability Sample

Study Population

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

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

Contacts and Locations

Please refer to this study by its ClinicalTrials.gov identifier: NCT00631839

Locations

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

Sponsors and Collaborators

Shanghai Cancer Hospital,China

Investigators

Principal Investigator:

Min Fan, MD

Fudan University Cancer Hospital, Department of Radiation Oncology

More Information

No publications provided

Responsible Party:	Shanghai Cancer Hospital, China ( Fan Min, Associate Professor, Vice Chief of Lung Cancer Center, Fudan University )
Study ID Numbers:	FDCA002
Study First Received:	March 2, 2008
Last Updated:	October 6, 2008
ClinicalTrials.gov Identifier:	NCT00631839 History of Changes
Health Authority:	China: Ethics Committee

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

Study placed in the following topic categories:

Thoracic Neoplasms
Esophageal Disorder
Esophageal Diseases

Additional relevant MeSH terms:

Thoracic Neoplasms
Neoplasms
Neoplasms by Site

ClinicalTrials.gov processed this record on July 06, 2009