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S9908, A Double-Blind, Placebo-Controlled Trial To Study The Efficacy And Safety Of L-Glutamine (In AES0014 Delivery Vehicle) Upon Radiation Therapy-Induced Oral Mucositis In Head and Neck Cancer Patients, Phase III


Phase 3
18 Years
90 Years
Not Enrolling
Both
Cancer-related Problem/Condition, Head and Neck Cancer, Pain

Thank you

Trial Information

S9908, A Double-Blind, Placebo-Controlled Trial To Study The Efficacy And Safety Of L-Glutamine (In AES0014 Delivery Vehicle) Upon Radiation Therapy-Induced Oral Mucositis In Head and Neck Cancer Patients, Phase III


OBJECTIVES:

- Compare the efficacy of L-glutamine vs placebo, in terms of maximum mucositis toxic
effects and worst reported mouth pain during and after high-dose radiotherapy, in
patients with newly diagnosed, previously untreated squamous cell cancer of the oral
cavity or oropharynx.

- Compare the duration of severe mucositis in patients treated with these regimens.

- Compare the radiotherapy delay in patients treated with these regimens.

- Compare weight loss in patients treated with these regimens.

- Compare the toxic effects of these two regimens in these patients.

- Compare patient-reported mouth pain success rate in patients treated with these
regimens.

- Determine the compliance of patients treated with this drug regimen.

OUTLINE: This is a randomized, double-blind, placebo-controlled, multicenter study. Patients
are stratified according to concurrent cisplatin or carboplatin (yes vs no), concurrent
fluorouracil (yes vs no), and presence of feeding tube (yes vs no). Patients are randomized
to 1 of 2 treatment arms.

- Arm I: Beginning 4 to 7 days prior to radiotherapy, patients receive oral L-glutamine 3
times daily for 60-80 days. Patients receive concurrent high-dose radiotherapy for
approximately 6 weeks.

- Arm II: Patients receive oral placebo and high-dose radiotherapy as in arm I. In both
arms, treatment continues in the absence of unacceptable toxicity.

Patients are followed for 2 weeks.

PROJECTED ACCRUAL: A total of 158 patients (79 per treatment arm) will be accrued for this
study within 2.5 years.

Inclusion Criteria


DISEASE CHARACTERISTICS:

- Newly diagnosed, previously untreated squamous cell cancer of the oral cavity or
oropharynx (T1-T4, any N, M0)

- Must be scheduled to receive high-dose radiotherapy

- Not concurrently receiving or planning to receive treatment on any other Southwest
Oncology Group protocol

PATIENT CHARACTERISTICS:

Age:

- 18 to 90

Performance status:

- Zubrod 0-2

Life expectancy:

- Not specified

Hematopoietic:

- Not specified

Hepatic:

- Not specified

Renal:

- Not specified

Other:

- No other malignancy within the past 5 years except adequately treated basal cell or
squamous cell skin cancer, carcinoma in situ of the cervix, or stage I or II cancer
currently in complete remission

- Not pregnant or nursing

- Fertile patients must use effective contraception

PRIOR CONCURRENT THERAPY:

Biologic therapy:

- Not specified

Chemotherapy:

- No prior chemotherapy

- Concurrent cisplatin, carboplatin, or fluorouracil allowed

- No other concurrent chemotherapy during study and for at least 3 weeks after study
radiotherapy

Endocrine therapy:

- Not specified

Radiotherapy:

- See Disease Characteristics

Surgery:

- Not specified

Other:

- No concurrent amifostine during and for 2 weeks after study radiotherapy

Type of Study:

Interventional

Study Design:

Allocation: Randomized, Masking: Double-Blind, Primary Purpose: Supportive Care

Principal Investigator

V. S. Klimberg, MD

Investigator Role:

Study Chair

Investigator Affiliation:

University of Arkansas

Authority:

United States: Federal Government

Study ID:

CDR0000068353

NCT ID:

NCT00006994

Start Date:

November 2001

Completion Date:

April 2006

Related Keywords:

  • Cancer-Related Problem/Condition
  • Head and Neck Cancer
  • Pain
  • oral complications of radiation therapy
  • pain
  • radiation toxicity
  • stage I squamous cell carcinoma of the lip and oral cavity
  • stage II squamous cell carcinoma of the lip and oral cavity
  • stage III squamous cell carcinoma of the lip and oral cavity
  • stage IV squamous cell carcinoma of the lip and oral cavity
  • stage I squamous cell carcinoma of the oropharynx
  • stage II squamous cell carcinoma of the oropharynx
  • stage III squamous cell carcinoma of the oropharynx
  • stage IV squamous cell carcinoma of the oropharynx
  • Head and Neck Neoplasms
  • Mouth Neoplasms
  • Mucositis

Name

Location

University of Texas - MD Anderson Cancer CenterHouston, Texas  77030-4009
University of Michigan Comprehensive Cancer CenterAnn Arbor, Michigan  48109-0752
Cardinal Bernardin Cancer Center at Loyola University Medical CenterMaywood, Illinois  60153-5500
Jonsson Comprehensive Cancer Center, UCLALos Angeles, California  90095-1781
MBCCOP - HawaiiHonolulu, Hawaii  96813
Barbara Ann Karmanos Cancer InstituteDetroit, Michigan  48201
University of Mississippi Medical CenterJackson, Mississippi  39216-4505
Arthur G. James Cancer Hospital - Ohio State UniversityColumbus, Ohio  43210
CCOP - Upstate CarolinaSpartanburg, South Carolina  29303
Tripler Army Medical CenterHonolulu, Hawaii  96859-5000
CCOP - WichitaWichita, Kansas  67214-3882
University of Texas Health Science Center at San AntonioSan Antonio, Texas  78284-7811
CCOP - Atlanta RegionalAtlanta, Georgia  30342-1701
CCOP - Kansas CityKansas City, Missouri  64131
CCOP - Southeast Cancer Control ConsortiumWinston-Salem, North Carolina  27104-4241
Veterans Affairs Medical Center - East OrangeEast Orange, New Jersey  07018-1095
CCOP - Michigan Cancer Research ConsortiumAnn Arbor, Michigan  48106
CCOP - DuluthDuluth, Minnesota  55805
NYU School of Medicine's Kaplan Comprehensive Cancer CenterNew York, New York  10016
Huntsman Cancer InstituteSalt Lake City, Utah  84112
Veterans Affairs Medical Center - Long BeachLong Beach, California  90822
Veterans Affairs Outpatient Clinic - MartinezMartinez, California  94553
CCOP - Bay Area Tumor InstituteOakland, California  94609-3305
CCOP - Santa Rosa Memorial HospitalSanta Rosa, California  95403
David Grant Medical CenterTravis Air Force Base, California  94535
CCOP - Central IllinoisSpringfield, Illinois  62526
Veterans Affairs Medical Center - LexingtonLexington, Kentucky  40511-1093
Veterans Affairs Medical Center - Ann ArborAnn Arbor, Michigan  48105
CCOP - Cancer Research for the OzarksSpringfield, Missouri  65807
CCOP - Montana Cancer ConsortiumBillings, Montana  59101
CCOP - ColumbusColumbus, Ohio  43206
Veterans Affairs Medical Center - DaytonDayton, Ohio  45428
CCOP - DaytonKettering, Ohio  45429
CCOP - GreenvilleGreenville, South Carolina  29615
Harrington Cancer CenterAmarillo, Texas  79106
University of Texas Medical BranchGalveston, Texas  77555-1329
CCOP - Western Regional, ArizonaPhoenix, Arizona  85006-2726
Chao Family Comprehensive Cancer Center at University of California Irvine Cancer CenterOrange, California  92868
University of Colorado Cancer Center at University of Colorado Health Sciences CenterDenver, Colorado  80010
MBCCOP - University of Illinois at ChicagoChicago, Illinois  60612
CCOP - Grand RapidsGrand Rapids, Michigan  49503
Keesler Medical Center - Keesler Air Force BaseKeesler AFB, Mississippi  39534-2576
MBCCOP - University of New Mexico HSCAlbuquerque, New Mexico  87131
Charles M. Barrett Cancer Center at University HospitalCincinnati, Ohio  45267-0526
CCOP - Columbia River Oncology ProgramPortland, Oregon  97225
CCOP - Scott and White HospitalTemple, Texas  76508
Cleveland Clinic Taussig Cancer CenterCleveland, Ohio  44195
MBCCOP - Gulf CoastMobile, Alabama  36688
Veterans Affairs Medical Center - Phoenix (Carl T. Hayden)Phoenix, Arizona  85012
Veterans Affairs Medical Center - TucsonTucson, Arizona  85723
Veterans Affairs Medical Center - Little Rock (McClellan)Little Rock, Arkansas  72205
Veterans Affairs Medical Center - West Los AngelesLos Angeles, California  90073
USC/Norris Comprehensive Cancer Center and HospitalLos Angeles, California  90033-0804
Veterans Affairs Medical Center - DenverDenver, Colorado  80220
Dwight David Eisenhower Army Medical CenterFort Gordon, Georgia  30905-5650
Veterans Affairs Medical Center - Chicago (Westside Hospital)Chicago, Illinois  60612
Veterans Affairs Medical Center - Hines (Hines Junior VA Hospital)Hines, Illinois  60141
Veterans Affairs Medical Center - WichitaWichita, Kansas  67218
MBCCOP - LSU Health Sciences CenterNew Orleans, Louisiana  70112
Louisiana State University Health Sciences Center - ShreveportShreveport, Louisiana  71130-3932
Veterans Affairs Medical Center - ShreveportShreveport, Louisiana  71130
Veterans Affairs Medical Center - DetroitDetroit, Michigan  48201-1932
Veterans Affairs Medical Center - JacksonJackson, Mississippi  39216
CCOP - St. Louis-Cape GirardeauSaint Louis, Missouri  63141
Veterans Affairs Medical Center - AlbuquerqueAlbuquerque, New Mexico  87108-5138
Veterans Affairs Medical Center - CincinnatiCincinnati, Ohio  45220-2288
Veterans Affairs Medical Center - PortlandPortland, Oregon  97207
Veterans Affairs Medical Center - CharlestonCharleston, South Carolina  29401-5799
Brooke Army Medical CenterFort Sam Houston, Texas  78234-6200
Veterans Affairs Medical Center - HoustonHouston, Texas  77030
Veterans Affairs Medical Center - San Antonio (Murphy)San Antonio, Texas  78284
Veterans Affairs Medical Center - TempleTemple, Texas  76504
Veterans Affairs Medical Center - Salt Lake CitySalt Lake City, Utah  84148
CCOP - Virginia Mason Research CenterSeattle, Washington  98101
Veterans Affairs Medical Center - SeattleSeattle, Washington  98108
CCOP - NorthwestTacoma, Washington  98405-0986
Madigan Army Medical CenterTacoma, Washington  98431-5048
Veterans Affairs Medical Center - New OrleansNew Orleans, Louisiana  70112
University of California Davis Cancer CenterSacramento, California  95817
City of Hope Comprehensive Cancer CenterDuarte, California  91010
UCSF Comprehensive Cancer CenterSan Francisco, California  94115
Danville Radiation Therapy CenterMemphis, Tennessee  38104
University of Tennessee Cancer InstituteMemphis, Tennessee  38103
Veterans Affairs Medical Center - AmarilloAmarillo, Texas  79106
Veterans Affairs Medical Center - DallasDallas, Texas  75216
CCOP - BeaumontRoyal Oak, Michigan  48073-6769
Arizona Cancer Center at University of Arizona Health Sciences CenterTucson, Arizona  85724
Arkansas Cancer Research Center at University of Arkansas for Medical SciencesLittle Rock, Arkansas  72205
Veterans Affairs Medical Center - Tampa (Haley)Tampa, Florida  33612
Kansas Masonic Cancer Research Institute at the University of Kansas Medical CenterKansas City, Kansas  66160-7353
Markey Cancer Center at University of Kentucky Chandler Medical CenterLexington, Kentucky  40536-0084
Tulane Cancer Center at Tulane University Hospital and ClinicNew Orleans, Louisiana  70112
Cancer Research Center at Boston Medical CenterBoston, Massachusetts  02118
Josephine Ford Cancer Center at Henry Ford HospitalDetroit, Michigan  48202
St. Louis University Hospital Cancer CenterSaint Louis, Missouri  63110
Herbert Irving Comprehensive Cancer Center at Columbia UniversityNew York, New York  10032
Veterans Affairs Medical Center - SalisburySalisbury, North Carolina  28144
Cancer Institute at Oregon Health and Science UniversityPortland, Oregon  97201-3098
Swedish Cancer Institute at Swedish Medical Center - First Hill CampusSeattle, Washington  98104
Oklahoma University Medical CenterOklahoma City, Oklahoma  73104
CCOP - Toledo Community HospitalToledo, Ohio  43623-3456
Hollings Cancer Center at Medical University of South CarolinaCharleston, South Carolina  29425
James P. Wilmot Cancer Center at University of Rochester Medical CenterRochester, New York  14642
MBCCOP - Howard University Cancer CenterWashington, District of Columbia  20060
Genesis Regional Cancer Center at Genesis Medical CenterDavenport, Iowa  52803
Providence Cancer Institute at Providence HospitalSouthfield, Michigan  48075