Radiation Therapy With or Without Chemotherapy in Reducing Mouth Dryness in Patients With Nasopharyngeal Cancer

PHASE2CompletedINTERVENTIONAL
Enrollment

68

Participants

Timeline

Start Date

February 28, 2003

Primary Completion Date

February 28, 2007

Study Completion Date

December 31, 2016

Conditions
Head and Neck CancerOral Complications of Radiation TherapyRadiation Toxicity
Interventions
DRUG

cisplatin

100 mg/m\^2 intravenously on days 1, 22, and 43 and 80 mg/m\^2 intravenously on days 71, 99, and 127

DRUG

fluorouracil

1000 mg/m\^2/day as 96-hour continuous infusion on days 71-74, 99-102, and 127-130

RADIATION

Intensity modulated radiation therapy

The gross tumor and lymph node metastasis, Planning Target Volume (PTV) 70 (Clinical Target Volume \[CTV\] 70 with a 5 mm margin) will receive 70 Gy in 33 fractions at 2.12 Gy per fraction. Treatment will be delivered once daily, 5 fractions per week, over 6 weeks and 3 days.

Trial Locations (17)

19096

CCOP - MainLine Health, Wynnewood

19107

Kimmel Cancer Center at Thomas Jefferson University - Philadelphia, Philadelphia

30501

Northeast Georgia Medical Center, Gainesville

35294

Comprehensive Cancer Center at University of Alabama at Birmingham, Birmingham

44304

Akron City Hospital, Akron

53226

Medical College of Wisconsin Cancer Center, Milwaukee

55905

Mayo Clinic Cancer Center, Rochester

63110

Siteman Cancer Center at Barnes-Jewish Hospital, St Louis

77030

M.D. Anderson Cancer Center at University of Texas, Houston

78236

Wilford Hall Medical Center, Lackland Air Force Base

84403

McKay-Dee Hospital Center, Ogden

87102

Albuquerque Regional Medical Center at Lovelace Sandia Health System, Albuquerque

94115

UCSF Comprehensive Cancer Center, San Francisco

95616

University of California Davis Cancer Center, Davis

95815

Radiological Associates of Sacramento Medical Group, Incorporated, Sacramento

07740

Monmouth Medical Center, Long Branch

19111-2497

Fox Chase-Temple Cancer Center, Philadelphia

All Listed Sponsors
collaborator

National Cancer Institute (NCI)

NIH

lead

Radiation Therapy Oncology Group

NETWORK

NCT00057785 - Radiation Therapy With or Without Chemotherapy in Reducing Mouth Dryness in Patients With Nasopharyngeal Cancer | Biotech Hunter | Biotech Hunter