MDACC Study Summary 2006-0947

Study Summary
No. 2006-0947:.......Head And Neck......Adam Garden......Radiation Oncology

Study Summary Title



Study Summary Number:	2006-0947

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

Physician

New Patient Referral



Name:	Adam Garden	Patients Call:	800-392-1611 (in U.S.A.) 713-792-6161 (outside U.S.A.)

Dept:	Radiation Oncology	Referring 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

General Information



Disease Group:	Head And Neck	Supported By:	N/A

Phase of Study:	N/A	Return Visit:	ART MRI at 12-14 weeks, routine surveillance appointments at 22-24 weeks and routine surveillance appointments every 3-4 months until 24 months post-ART.

Treatment Agents:	Radiation	Home 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 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.

Study Objectives / Outcomes

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.

Study Status Information



Study Activation / Registration Date:	06/20/2007

IRB Review and Approval Date:	06/20/2007

Study Type:	Other

Recruitment Status:	Closed

Projected Accrual:	N/A

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 older than 18 years of age with histologically proven squamous cell carcinoma of the oropharynx, dispositioned to receive definitive radiotherapy for intact primary tumor.

2) Stage III, IVa, or IVb disease as defined by American Joint Committee on Cancer (AJCC) cancer staging criteria.

3) ECOG performance status 0-2.

Exclusion Criteria:

1) Patients who have undergone definitive resection of the primary tumor.

2) Prior cancer diagnosis, except appropriately treated localized epithelial skin cancer or cervical cancer.

3) Prior radiation therapy to the head and neck region.

4) Patients unable or unwilling to give written, informed consent or to undergo MRI imaging.

5) 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

6) Patients unable to tolerate DW-MRI or DCE-MRI or having an estimated GFR < 60 ml/min/1.73m2.

7) Patients who have had prior chemotherapy.

Links

Registration Number: NCT00490282
Study Information on Clinical Trials Registry (clinicaltrials.gov)