MDACC Study Summary RTOG-0225

Study Summary
No. RTOG-0225:.......Head And Neck......Adam Garden......Radiation Oncology

Study Summary Title



Study Summary Number:	RTOG-0225

Study Title:	A PHASE II STUDY OF INTENSITY MODULATED RADIATION THERAPY (IMRT) +/- CHEMOTHERAPY FOR NASOPHARYNGEAL 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:	713-792-3400 Contact us about clinical trials

General Information



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

Phase of Study:	Phase II	Return Visit:	Every 3 months for 2 years, then every 6 months for 3 years and once annual afterwards.

Treatment Agents:	5-FU Cisplatin Radiation	Home Care:	none

Treatment Loc:	Independent Multicenter Arrangements

Estimated Length of Stay in Houston:	outpatient therapy


Description/ Intervention:	The goal of this clinical research study is to learn if the use of advanced radiation therapy delivery techniques given with or without chemotherapy can spare normal tissue, including salivary glands, from radiation damage in patients with head and neck cancer. The safety of the advanced radiation therapy delivery techniques will also be studied.

Study Objectives / Outcomes

To determine the transportability of IMRT to a multi-institutional setting.

To estimate the rate of late xerostomia (defined as one year) associated with this regimen.

To test the hypothesis that a potential reduction of radiation side effects on salivary flow using IMRT
will increase patient compliance to combined therapy without compromising local-regional control.

To estimate the rates of local-regional control, distant metastasis, disease-free and overall survival.

To assess other acute and late toxicities of this regimen.

To evaluate chemotherapy compliance with this regimen.

Study Status Information



Study Activation / Registration Date:	07/25/2003

IRB Review and Approval Date:	07/02/2003

Study Type:	Therapeutic

Recruitment Status:	Closed

Projected Accrual:	64

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) Confirmed histopathologic diagnosis of nasopharyngeal squamous cell carcinoma, types WHO I-III, Stage I-IVB, requiring primary irradiation

2) No head and neck surgery of the primary tumor or lymph nodes except for incisional or excisional biopsies

3) Zubrod performance status 0-1

4) WBC > 4,000/ml, platelets > 100,000/ml; serum creatinine < 1.6 mg/dl or 24 hr. calculated creatinine clearance > 60 ml/min

5) Nutritional and general physical condition must be considered compatible with the proposed radio-therapeutic treatment

6) Signed study-specific consent form prior to study entry

7) Patients must be greater than or equal to 18 years of age to be eligible for this study.

Exclusion Criteria:

1) Stage IVC.

2) Evidence of distant metastases.

3) Previous irradiation for head and neck tumor < 6 months prior to study entry.

4) Prior chemotherapy < 6 months prior to study entry.

5) Patient is on other experimental therapeutic cancer treatment.

6) Other malignancy except non-melanoma skin cancer or a carcinoma not of head and neck origin and controlled at least 5 years.

7) Active untreated infection.

8) Major medical or psychiatric illness, which in the investigators' opinions, would interfere with either the completion of therapy and follow-up or with full and complete understanding of the risks and potential complications of the therapy.

9) Pregnant women who are node positive or Stage > T2b because of the embryotoxic effects of chemotherapy.

Links

Registration Number: NCT00057785
Study Information on Clinical Trials Registry (clinicaltrials.gov)