Know Cancer

or
forgot password

Induction Chemotherapy Followed By Chemoradiation For Organ Preservation In Patients With Advanced Resectable Cancer Of The Hypopharynx And Base Of Tongue, Phase II


Phase 2
18 Years
N/A
Not Enrolling
Both
Head and Neck Cancer

Thank you

Trial Information

Induction Chemotherapy Followed By Chemoradiation For Organ Preservation In Patients With Advanced Resectable Cancer Of The Hypopharynx And Base Of Tongue, Phase II


OBJECTIVES: I. Determine the complete histologic response rate (which represents the rate of
organ preservation) to induction with cisplatin/fluorouracil followed by radiotherapy plus
cisplatin in patients with selected stage III/IV cancer of the hypopharynx or base of the
tongue. II. Evaluate the feasibility of accruing and treating patients with this regimen in
a multi-institutional setting. III. Determine the overall complete response rate in these
patients.

OUTLINE: This is a multicenter study. Patients are stratified according to center and tumor
site (hypopharynx vs base of tongue). Base of tongue stratum closed as of November 15, 1998.
Regimen A: Patients receive cisplatin IV over 90 minutes on days 1 and 22 and fluorouracil
IV over 120 minutes on days 1-5 and 22-26. Patients with measurable neck nodes discontinue
therapy if disease has progressed by day 22. All patients who achieve complete or partial
response at day 43 proceed to regimen B. All others proceed to resection followed by
radiotherapy (off study). Regimen B (begins within 3-4 weeks of start of second induction
course): Patients receive cisplatin IV over 90 minutes every 3 weeks for 3 courses.
Concurrently, patients receive radiotherapy 5 days a week for 5.6 weeks. Patients are
reassessed at 8-12 weeks after radiotherapy. Patients who are disease free are observed.
Other patients undergo surgical resection of nodes and/or primary tumor. Patients are
followed every 4-6 weeks for 1 year, every 2 months for 1 year, every 4 months for 2 years,
every 6 months for 1 year, then annually thereafter.

PROJECTED ACCRUAL: Up to 70 patients (35/tumor site) will be accrued for this study over 3.5
years.

Inclusion Criteria


DISEASE CHARACTERISTICS: Histologically confirmed squamous cell carcinoma of the
hypopharynx or base of the tongue that is newly diagnosed and considered resectable For
hypopharyngeal cancer, total laryngectomy would be required surgery Disease staged by
clinical exam, endoscopy, and CT or MRI Stage III that is T2-3 N0-1 M0 Stage IV that is
T2-3 N2-3 M0 Measurable or evaluable disease other than pleural effusion, ascites, or
disease documented by indirect evidence Closed to patients with cancer of the base of
tongue as of 11/15/1998

PATIENT CHARACTERISTICS: Age: Adult Performance status: SWOG 0 or 1 Hematopoietic: WBC at
least 3,000/mm3 Absolute neutrophil count at least 1,500/mm3 Platelet count at least
100,000/mm3 Hepatic: Bilirubin no greater than 2 times normal AST or ALT no greater than 3
times normal Renal: Creatinine no greater than 2 times normal Creatinine clearance at
least 60 mL/min Magnesium normal (supplementation allowed) Other: Average hearing loss in
both ears no greater than 40 dB in 50-2,000 Hz range No second malignancy within 5 years
except: Adequately treated nonmelanomatous skin cancer Carcinoma in situ of the cervix
Stage I/II cancer (other than head/neck) in complete remission Not pregnant or nursing
Effective contraception required of fertile patients

PRIOR CONCURRENT THERAPY: No prior therapy

Type of Study:

Interventional

Study Design:

Endpoint Classification: Efficacy Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment

Outcome Measure:

Complete response

Outcome Description:

Complete disappearance of all measurable and evaluable disease. No new lesions, No disease related symptoms. No evidence of non-evaluable disease, including normalization of markers and other abnormal lab values. Specifically, the rate of organ preservation (no surgery required at the primary tumor site).

Outcome Time Frame:

23 to 27 weeks after beginning treatment

Safety Issue:

No

Principal Investigator

Susan G. Urba, MD

Investigator Role:

Study Chair

Investigator Affiliation:

University of Michigan Cancer Center

Authority:

United States: Federal Government

Study ID:

CDR0000064634

NCT ID:

NCT00002735

Start Date:

April 1996

Completion Date:

March 2005

Related Keywords:

  • Head and Neck Cancer
  • stage III squamous cell carcinoma of the oropharynx
  • stage IV squamous cell carcinoma of the oropharynx
  • stage III squamous cell carcinoma of the hypopharynx
  • stage IV squamous cell carcinoma of the hypopharynx
  • Head and Neck Neoplasms

Name

Location

University of Michigan Comprehensive Cancer CenterAnn Arbor, Michigan  48109-0752
USC/Norris Comprehensive Cancer CenterLos Angeles, California  90033-0800
University of Colorado Cancer CenterDenver, Colorado  80262
Barbara Ann Karmanos Cancer InstituteDetroit, Michigan  48201
Cleveland Clinic Cancer CenterCleveland, Ohio  44195
MBCCOP - LSU Medical CenterNew Orleans, Louisiana  70112
Henry Ford HospitalDetroit, Michigan  48202
Veterans Affairs Medical Center - Ann ArborAnn Arbor, Michigan  48105
University of Texas Medical BranchGalveston, Texas  77555-1329
CCOP - Scott and White HospitalTemple, Texas  76508
University of Arkansas for Medical SciencesLittle Rock, Arkansas  72205
University of Kansas Medical CenterKansas City, Kansas  66160-7353
Veterans Affairs Medical Center - DetroitDetroit, Michigan  48201-1932
Veterans Affairs Medical Center - Kansas CityKansas City, Missouri  64128
Oklahoma Medical Research FoundationOklahoma City, Oklahoma  73104
Veterans Affairs Medical Center - Oklahoma CityOklahoma City, Oklahoma  73104
Veterans Affairs Medical Center - TempleTemple, Texas  76504
Veterans Affairs Medical Center - BrooklynBrooklyn, New York  11209