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

This study is currently recruiting participants.

Verified by M.D. Anderson Cancer Center, March 2009

First Received: June 21, 2007 Last Updated: March 13, 2009 History of Changes

Sponsors and Collaborators:	M.D. Anderson Cancer Center National Cancer Institute (NCI)
Information provided by:	M.D. Anderson Cancer Center
ClinicalTrials.gov Identifier:	NCT00490282

Purpose

Primary Objectives:

To demonstrate improved normal tissue sparing dosimetry with head and neck (H&N) adaptive radiotherapy (ART) planning relative to standard intensity-modulated radiation therapy (IMRT) planning in 30 locally advanced oropharyngeal cancer patients.

Secondary Objectives:

To document improved acute toxicity outcomes with ART.
To document pilot evidence that serial functional MRI imaging will predict disease response.

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: Cancer Head and Neck Cancer Nuclear Scans Radiation Therapy

U.S. FDA Resources

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

Primary Outcome Measures:

To use computed tomography (CT) scans to measure and guide radiation therapy. [ Time Frame: 3 years ] [ 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:	30
Study Start Date:	June 2007
Estimated Primary Completion Date:	June 2010 (Final data collection date for primary outcome measure)

Arms	Assigned Interventions
1: Experimental Intensity Modulated Radiotherapy + Adaptive Radiotherapy	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: David Schwartz, MD

713-562-2300

Locations

United States, Texas
U.T.M.D. Anderson Cancer Center	Recruiting
Houston, Texas, United States, 77030
Principal Investigator: David Schwartz, MD

Sponsors and Collaborators

M.D. Anderson Cancer Center

National Cancer Institute (NCI)

Investigators

Principal Investigator:

David Schwartz, MD

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 ( David Schwartz, MD/Assistant Professor )
Study ID Numbers:	2006-0947
Study First Received:	June 21, 2007
Last Updated:	March 13, 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

Study placed in the following topic categories:

Otorhinolaryngologic Diseases
Otorhinolaryngologic Neoplasms
Head and Neck Neoplasms
Pharyngeal Neoplasms

Stomatognathic Diseases
Pharyngeal Diseases
Oropharyngeal Neoplasms

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 July 06, 2009