3-Dimensional Conformal Radiation Therapy Versus Intensity Modulated Radiation Therapy - Full Text View

Sponsor:	M.D. Anderson Cancer Center
Information provided by:	M.D. Anderson Cancer Center
ClinicalTrials.gov Identifier:	NCT00520702

Purpose

Primary Objective:

Developing Common Toxicity Criteria (CTC) 3.0 grade > 3 treatment related pneumonitis (TRP) or
Developing local-regional recurrence among patients treated with 3D conformal radiation therapy (CRT) (Arm 1) or intensity modulated radiation therapy (IMRT) (Arm 2).

Secondary Objectives:

To assess and compare the time to develop CTC 3.0 grade > 3 radiation esophagitis in patients with non-small cell lung cancer (NSCLC) treated in arm 1 and arm 2.
To investigate the association of inflammatory cytokines with the time to the development of radiation pneumonitis and outcomes to concurrent chemoradiation between arm 1 and arm 2.
To investigate the association of relevant pharmacogenetics, biomarkers, and gene polymorphisms with the time to the development of radiation pneumonitis and treatment outcomes to concurrent chemoradiation between arm 1 and arm 2.
To evaluate image guided adaptive radiation therapy (IGART) using weekly computed tomography (CT) on rail or cone beam CT in the assessment of tumor response and impact on treatment planning and delivery.
To compare overall survival, progression-free survival, median survival time, in arm 1 and arm 2.
To evaluate the role of functional image of fluorodeoxyglucose-positron emission tomography (FDG-PET) in assessing and predicting the time to the development of TRP and tumor response.
To measure and compare symptom burden over time of the treatment using MD Anderson Symptom Inventory (MDASI)-Lung in the 2 arms.
To determine the impact of comorbid conditions on survival.

Condition	Intervention	Phase
Lung Cancer	Procedure: Intensity Modulated Radiation Therapy Procedure: 3-Dimensional Conformal Radiation Therapy	Phase II

Study Type:	Interventional
Study Design:	Diagnostic, Randomized, Open Label, Uncontrolled, Parallel Assignment, Efficacy Study
Official Title:	A Randomized Trial to Compare Time to Common Toxicity Criteria for Adverse Effect (CTC AEC) 3.0 Grade. 3 Treatment Related Pneumonitis (TRP) in Patients With Locally Advanced Non-Small Cell Lung Carcinoma (NSCLC) Receiving Concurrent Chemoradiation Radiation Treated With 3-Dimensional Conformal Radiation Therapy (3D CRT, ARM 1) Versus Intensity Modulated Radiation Therapy (IMRT, ARM 2) Using 4-Dimensional CT Planning and Image Guided Adaptive Radiation Therapy (IGART)

Resource links provided by NLM:

MedlinePlus related topics: Cancer Lung Cancer Pneumonia

U.S. FDA Resources

Further study details as provided by M.D. Anderson Cancer Center:

Primary Outcome Measures:

To compare intensity-modulated radiation therapy (IMRT) with three-dimensional conformal radiation therapy (3D CRT) in the ability to decrease the risk of treatment-related pneumonitis (TRP). [ Time Frame: 3 Years ] [ Designated as safety issue: No ]

Estimated Enrollment:	168
Study Start Date:	August 2007
Estimated Primary Completion Date:	August 2010 (Final data collection date for primary outcome measure)

Arms	Assigned Interventions
3D CRT: Active Comparator 3-Dimensional Conformal Radiation Therapy (3D CRT)	Procedure: 3-Dimensional Conformal Radiation Therapy 66 Gy in 33 Daily Fractions at 2 Gy per fraction.
IMRT: Active Comparator Intensity-Modulated Radiation Therapy (IMRT)	Procedure: Intensity Modulated Radiation Therapy 66 Gy in 33 Daily Fractions at 2 Gy per fraction.

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Eligibility

Ages Eligible for Study:	18 Years to 80 Years
Genders Eligible for Study:	Both
Accepts Healthy Volunteers:	No

Criteria

Inclusion Criteria:

Pathologically proven diagnosis of unresected loco-regionally advanced non-small cell lung cancer without evidence of hematogenous metastases, Stages IIB-IIIB without contralateral hilar nodal disease.
Patient is suitable for concurrent chemoradiation therapy per treating physician's assessment (kps >/= 70, weight loss < 10% in three months prior to diagnosis).
Patients with Stage IV NSCLC with solitary metastasis (brain, one side of adrenal gland, or one site of bone), who have clinical indication of concurrent chemoradiation to the primary disease in the lung are eligible.
Patients who received induction chemotherapy and then referred for concurrent chemoradiation are eligible.
Patients who had local regional recurrence after surgical resection and who are suitable for definitive concurrent chemoradiation are eligible.
Measurable disease by chest x-ray and/or contrast-enhanced CT, and/or PET scan
FEV 1> 1000 cc
Pre-chemoradiation FDG-PET within 10 weeks prior to randomization. This PET/CT is a standard procedure for staging. It is strongly encouraged to have this PET/CT performed at the same time for 4-D CT simulation using the 4-D PET/CT scanner at the department of radiation oncology.
Patient will undergo routine standard pretreatment evaluations as decided by treating physician, which usually include magnetic resonance imaging (MRI) or CT of the brain, contrast CT scan of the thorax and upper abdomen, pulmonary functional test, single-photon emission computerized tomography (SPECT), liver function tests (LFT), blood chemistry, renal functional test, complete blood count.
Age > 18, < 80 years
Patient must sign study specific informed consent prior to study entry.

Exclusion Criteria:

Evidence of small cell histology
Prior radiotherapy to the region of the study cancer that would result in overlap of radiation therapy fields
Pregnant women are ineligible as the treatment involves unforeseeable risks to the participant and to the embryo or fetus. Patients with childbearing potential must practice appropriate contraception.
Patient has enrolled in a clinical trial that specifically does not allow IMRT treatment

Contacts and Locations

Please refer to this study by its ClinicalTrials.gov identifier: NCT00520702

Locations

United States, Texas
U.T.M.D. Anderson Cancer Center
Houston, Texas, United States, 77030

Sponsors and Collaborators

M.D. Anderson Cancer Center

Investigators

Principal Investigator:

Zhongxing Liao, MD

U.T.M.D. Anderson Cancer Center

More Information

Additional Information:

MD Anderson Cancer Center This link exits the ClinicalTrials.gov site

No publications provided

Responsible Party:	U.T.M.D. Anderson Cancer Center ( Zhongxing Liao, MD/Associate Professor )
Study ID Numbers:	2006-0222
Study First Received:	August 22, 2007
Last Updated:	June 26, 2009
ClinicalTrials.gov Identifier:	NCT00520702 History of Changes
Health Authority:	United States: Institutional Review Board

Keywords provided by M.D. Anderson Cancer Center:

Non-Small Cell Lung Cancer
Lung Cancer
3-Dimensional Conformal Radiation Therapy
Intensity Modulated Radiation Therapy
3D CRT

IMRT
NSCLC
TRP
Treatment related pneumonitis

Additional relevant MeSH terms:

Thoracic Neoplasms
Respiratory Tract Neoplasms
Neoplasms
Neoplasms by Site
Neoplasms by Histologic Type
Respiratory Tract Diseases

Lung Neoplasms
Lung Diseases
Carcinoma, Non-Small-Cell Lung
Neoplasms, Glandular and Epithelial
Carcinoma

ClinicalTrials.gov processed this record on November 22, 2009