SWOG-9451, Combination Chemo & RT For Patients With Stage III/Stage IV Cancer of the Hypopharynx or Tongue

This study has been terminated.
(Terminated due to poor accrual.)
Sponsor:
Collaborator:
Information provided by (Responsible Party):
Southwest Oncology Group
ClinicalTrials.gov Identifier:
NCT00002735
First received: November 1, 1999
Last updated: June 13, 2012
Last verified: June 2012
  Purpose

RATIONALE: Drugs used in chemotherapy use different ways to stop tumor cells from dividing so they stop growing or die. Radiation therapy uses high-energy x-rays to damage tumor cells. Combining more than one chemotherapy drug with radiation therapy may kill more tumor cells.

PURPOSE: Phase II trial to study the effectiveness of combination chemotherapy and radiation therapy in treating patients with stage III or stage IV cancer of the hypopharynx or tongue.


Condition Intervention Phase
Head and Neck Cancer
Drug: Induction chemotherapy
Drug: cisplatin
Drug: fluorouracil
Radiation: low-LET cobalt-60 gamma ray therapy
Phase 2

Study Type: Interventional
Study Design: Endpoint Classification: Efficacy Study
Intervention Model: Single Group Assignment
Masking: Open Label
Primary Purpose: Treatment
Official Title: Induction Chemotherapy Followed By Chemoradiation For Organ Preservation In Patients With Advanced Resectable Cancer Of The Hypopharynx And Base Of Tongue, Phase II

Resource links provided by NLM:


Further study details as provided by Southwest Oncology Group:

Primary Outcome Measures:
  • Complete response [ Time Frame: 23 to 27 weeks after beginning treatment ] [ Designated as safety issue: No ]
    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).


Enrollment: 68
Study Start Date: April 1996
Study Completion Date: March 2005
Primary Completion Date: April 2004 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: Treatment arm
induction chemotherapy followed by chemoradiation
Drug: Induction chemotherapy
Cisplatin and 5-Fluorouracil
Other Names:
  • platinol
  • 5-FU
Drug: cisplatin
Cisplatin 100 mg/m2 IV infusion over 90 minutes Day 1 every 21 days for 2 cycles.
Other Name: platinol
Drug: fluorouracil
5-Fluorouracil 1,000 mg/m2/day continuous IV infusion over 24 hours Days 1 through 5 every 21 days for 2 cycles.
Other Name: 5-FU
Radiation: low-LET cobalt-60 gamma ray therapy
180 cGy per day, Days 1-5, every week for eight weeks
Other Name: RT

Detailed Description:

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.

  Eligibility

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
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

  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT00002735

Locations
United States, Arkansas
University of Arkansas for Medical Sciences
Little Rock, Arkansas, United States, 72205
United States, California
USC/Norris Comprehensive Cancer Center
Los Angeles, California, United States, 90033-0800
United States, Colorado
University of Colorado Cancer Center
Denver, Colorado, United States, 80262
United States, Kansas
University of Kansas Medical Center
Kansas City, Kansas, United States, 66160-7357
United States, Louisiana
MBCCOP - LSU Medical Center
New Orleans, Louisiana, United States, 70112
United States, Michigan
University of Michigan Comprehensive Cancer Center
Ann Arbor, Michigan, United States, 48109-0752
Veterans Affairs Medical Center - Ann Arbor
Ann Arbor, Michigan, United States, 48105
Barbara Ann Karmanos Cancer Institute
Detroit, Michigan, United States, 48201
Henry Ford Hospital
Detroit, Michigan, United States, 48202
Veterans Affairs Medical Center - Detroit
Detroit, Michigan, United States, 48201-1932
United States, Missouri
Veterans Affairs Medical Center - Kansas City
Kansas City, Missouri, United States, 64128
United States, New York
Veterans Affairs Medical Center - Brooklyn
Brooklyn, New York, United States, 11209
United States, Ohio
Cleveland Clinic Cancer Center
Cleveland, Ohio, United States, 44195
United States, Oklahoma
Oklahoma Medical Research Foundation
Oklahoma City, Oklahoma, United States, 73104
Veterans Affairs Medical Center - Oklahoma City
Oklahoma City, Oklahoma, United States, 73104
United States, Texas
University of Texas Medical Branch
Galveston, Texas, United States, 77555-1329
CCOP - Scott and White Hospital
Temple, Texas, United States, 76508
Veterans Affairs Medical Center - Temple
Temple, Texas, United States, 76504
Sponsors and Collaborators
Southwest Oncology Group
Investigators
Study Chair: Susan G. Urba, MD University of Michigan Cancer Center
  More Information

Publications:
Urba S, Moon J, LeBlanc M, et al.: Induction chemotherapy followed by chemoradiation for organ preservation in patients (pts) with advanced resectable cancer of the base of tongue (BOT) and hypopharynx (HP): a Southwest Oncology Group trial. [Abstract] Proceedings of the American Society of Clinical Oncology 21: A-919, 2002.

Responsible Party: Southwest Oncology Group
ClinicalTrials.gov Identifier: NCT00002735     History of Changes
Other Study ID Numbers: CDR0000064634, SWOG-9451, U10CA032102
Study First Received: November 1, 1999
Last Updated: June 13, 2012
Health Authority: United States: Federal Government

Keywords provided by Southwest Oncology Group:
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

Additional relevant MeSH terms:
Head and Neck Neoplasms
Neoplasms by Site
Neoplasms
Cisplatin
Fluorouracil
Antineoplastic Agents
Therapeutic Uses
Pharmacologic Actions
Radiation-Sensitizing Agents
Antimetabolites
Molecular Mechanisms of Pharmacological Action
Antimetabolites, Antineoplastic
Immunosuppressive Agents
Immunologic Factors
Physiological Effects of Drugs

ClinicalTrials.gov processed this record on October 01, 2014