A Pilot Trial of Image-Guided Adaptive Radiotherapy for Head and Neck Cancer - Full Text View

Sponsor:	M.D. Anderson Cancer Center
Collaborator:	National Cancer Institute (NCI)
Information provided by:	M.D. Anderson Cancer Center
ClinicalTrials.gov Identifier:	NCT00490282

Purpose

The goal of this clinical research study is to use computed tomography (CT) scans to measure and guide your radiation therapy. Researchers want to learn if the CT scans can be used to adapt radiation therapy to the changes in normal tissue and to the shrinking of the tumor that may occur as a reaction to radiation therapy. Researchers also want to see if magnetic resonance imaging (MRI) scanning can detect certain changes in the tumor any earlier than with standard tests.

Condition	Intervention
Head and Neck Cancer Oropharyngeal Cancer	Radiation: Intensity Modulated Radiation Therapy Radiation: Adaptive Radiotherapy

Study Type:	Interventional
Study Design:	Diagnostic, Non-Randomized, Open Label, Uncontrolled, Single Group Assignment
Official Title:	A Pilot Trial of Image-Guided Adaptive Radiotherapy for Head and Neck Cancer

Resource links provided by NLM:

MedlinePlus related topics: CT Scans Cancer Head and Neck Cancer MRI Scans Nuclear Scans

U.S. FDA Resources

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

Primary Outcome Measures:

Comparison of dosimetry with head and neck (H&N) adaptive radiotherapy (ART) planning relative to standard intensity-modulated radiation therapy (IMRT) planning [ Time Frame: Baseline by standard IMRT plan and adaptive dosing by ART plan evaluated at end of ART at week 6-7. ] [ Designated as safety issue: No ]

Secondary Outcome Measures:

To learn if the CT scans can be used to adapt radiation therapy to the changes in normal tissue and to the shrinking of the tumor that may occur as a reaction to radiation therapy [ Time Frame: 3 years ] [ Designated as safety issue: No ]
To see if magnetic resonance imaging (MRI) scanning can detect certain changes in the tumor any earlier than with standard tests. [ Time Frame: 3 years ] [ Designated as safety issue: No ]

Estimated Enrollment:	45
Study Start Date:	June 2007
Estimated Primary Completion Date:	June 2010 (Final data collection date for primary outcome measure)

Arms	Assigned Interventions
Image-Guided Adaptive Radiotherapy: Experimental Intensity Modulated Radiotherapy (IMRT) + Adaptive Radiotherapy (ART)	Radiation: Intensity Modulated Radiation Therapy IMRT Treatment Over 6-7 Weeks Radiation: Adaptive Radiotherapy ART Treatment Over 6-7 Weeks

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Eligibility

Ages Eligible for Study:	18 Years and older
Genders Eligible for Study:	Both
Accepts Healthy Volunteers:	No

Criteria

Inclusion Criteria:

Patients older than 18 years of age with histologically proven squamous cell carcinoma of the oropharynx, dispositioned to receive definitive radiotherapy for intact primary tumor.
Stage III, IVa, or IVb disease as defined by American Joint Committee on Cancer (AJCC) cancer staging criteria.
ECOG performance status 0-2.

Exclusion Criteria:

Patients who have undergone definitive resection of the primary tumor.
Prior cancer diagnosis, except appropriately treated localized epithelial skin cancer or cervical cancer.
Prior radiation therapy to the head and neck region.
Patients unable or unwilling to give written, informed consent or to undergo MRI imaging.
Women of childbearing potential (A woman of child-bearing potential is a sexually mature woman who has not undergone a hysterectomy or who has not been naturally postmenopausal for at least 24 consecutive months [i.e., who has had menses at any time in the preceding 24 consecutive months]) and male participants must practice effective contraception (oral, injectable, or implantable hormonal contraceptive; tubal ligation; intra-uterine device; barrier contraceptive with spermicide; or vasectomized partner) throughout the study
Patients unable to tolerate DW-MRI or DCE-MRI or having an estimated GFR < 60 ml/min/1.73m2.
Patients who have had prior chemotherapy.

Contacts and Locations

Please refer to this study by its ClinicalTrials.gov identifier: NCT00490282

Contacts

Contact: Adam Garden, MD, BA

713-562-2300

Locations

United States, Texas
U.T.M.D. Anderson Cancer Center	Recruiting
Houston, Texas, United States, 77030
Principal Investigator: Adam Garden, MD, BA

Sponsors and Collaborators

M.D. Anderson Cancer Center

National Cancer Institute (NCI)

Investigators

Principal Investigator:

Adam Garden, MD, BA

U.T.M.D. Anderson Cancer Center

More Information

Additional Information:

Related Info This link exits the ClinicalTrials.gov site

No publications provided

Responsible Party:	U.T.M.D. Anderson Cancer Center ( Adam Garden, MD, BA / Professor )
Study ID Numbers:	2006-0947
Study First Received:	June 21, 2007
Last Updated:	September 8, 2009
ClinicalTrials.gov Identifier:	NCT00490282 History of Changes
Health Authority:	United States: Institutional Review Board

Keywords provided by M.D. Anderson Cancer Center:

Head and Neck Cancer
Oropharyngeal Cancer
Adaptive Radiotherapy

Intensity Modulated Radiation Therapy
IMRT
ART

Additional relevant MeSH terms:

Neoplasms
Otorhinolaryngologic Diseases
Otorhinolaryngologic Neoplasms
Neoplasms by Site
Head and Neck Neoplasms

Pharyngeal Neoplasms
Stomatognathic Diseases
Pharyngeal Diseases
Oropharyngeal Neoplasms

ClinicalTrials.gov processed this record on November 30, 2009