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Study Summary
No. 2003-0962:.......Bladder; Breast; Colorectal; Esophageal; Gastric; Gastrointestinal; Genitourinary; Gynecology; Liver; Lung; Lymphoma; Prostate; Small Bowel......James D. Cox......Radiation Oncology
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Study Summary Title
Study Summary
Number:
2003-0962
Study Title:Assessing the Magnitude and Potential Impact of Respiration-Induced Three-Dimensional Motion of Tumors and Normal Tissues Using Four-Dimensional CT Technology
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Physician New Patient Referral
Name:James D. CoxPatients Call:800-392-1611 (in U.S.A.) 713-792-6161 (outside U.S.A.)
Dept:Radiation OncologyReferring MD
Call:
800-392-1611 (in U.S.A.) 713-792-6161 (outside U.S.A.)
Phone:713-563-2300
Contact us about clinical trials
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General Information
Disease Group:Bladder
Breast
Colorectal
Esophageal
Gastric
Gastrointestinal
Genitourinary
Gynecology
Liver
Lung
Lymphoma
Prostate
Small Bowel
Supported By:N/A
Phase of Study:N/AReturn
Visit:
CT scans will be acquired during a patient's course of radiation therapy, so no
additional visits to MDACC will be necessary.
Treatment
Agents:
NoneHome Care:n/a
Treatment Loc:Only at MDACC
Estimated
Length of Stay
in Houston:
n/a
Description/
Intervention:
The goal of this clinical research study is to collect accurate and reliable
information as to how tumors as well as the organs surrounding tumors move
while breathing.
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Study Objectives / Outcomes
Primary Objectives:
    1. To collect accurate and reliable respiration-induced anatomic structure motion data using four-dimensional (4-D) imaging technology.
    2. To analyze these data to study respiration-induced variations and patterns in variations of positions, shapes and volumes of tumors and normal anatomic structures in the thorax and abdomen over a breathing cycle, from one breathing cycle to the next, day-to-day and over the course of radiotherapy.
    3. To assess dosimetric and potential clinical consequences of respiratory motion in the current practice of radiotherapy through preclinical treatment simulation (treatment planning) studies.
    4. To quantify the potential consequences of explicitly accounting for respiration-induced motion on dose distributions and outcome (tumor control probabilities and normal tissue complication probabilities) through preclinical treatment simulation studies.

Secondary Objectives:
    1. To investigate the feasibility of using patient training to regulate patient breathing and improve the quality of images and to stratify patients for their eligibility for respiratory-correlated imaging and radiotherapy and for the implementation of various strategies for mitigation of respiratory-induced motion.
    2. To assess the degree of correlation of the marker (or internal anatomic structure such as diaphragm) being tracked as surrogate of breathing with the motion of structures and the intra-fraction and inter-fraction reproducibility of such correlation.
    3. To quantify the effects of radiation therapy on the patterns of respiratory-induced motion of structures through preclinical treatment simulation studies.
    4. To compare various strategies for either accounting for or mitigating respiration-induced motion in the planning and delivery of radiation therapy.
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Study Status Information
Study Activation / Registration Date:11/16/2004
IRB Review and Approval Date:02/18/2004
Study Type:Not Applicable
Recruitment Status:Closed
Projected Accrual:210
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Enrollment Eligibility
If you do not meet the enrollment eligibility, there may be other treatment options for you. Please Contact the Referral Office for more information.

Inclusion Criteria:1) Patients with pathological diagnosis of cancer in the thorax or abdomen.

2) Patients must be planned to have radiation therapy delivered over at least 4 weeks (a minimum standard duration of curative radiotherapy).

3) Patients must be able to lie flat for the duration of the CT image acquisition sessions.

Exclusion Criteria:1) Patients who are neither able to breathe nor hold breath in a regular and reproducible manner will be removed from the study as being ineligible. Breathing or breath-holding regularity determination will be based on respiration traces acquired with the RPM system.

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Links
Registration Number: NCT00415675
Study Information on Clinical Trials Registry (clinicaltrials.gov)

Other Links:
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Results


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