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

Head and Neck Cancer Clinical Trial

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

Clinical Trial Details — Status: Terminated

Administrative data

• NCT number: NCT00002735
• Other study ID #: CDR0000064634
• Secondary ID: SWOG-9451U10CA03
• Status: Terminated
• Phase: Phase 2
• First received: November 1, 1999
• Last updated: September 28, 2015
• Start date: April 1996
• Est. completion date: March 2005

Study information

• Verified date: September 2015
• Source: Southwest Oncology Group
• Contact: n/a
• Is FDA regulated: No
• Health authority: United States: Federal Government
• Study type: Interventional

Clinical Trial Summary

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.

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.

Recruitment information / eligibility

• Status: Terminated
• Enrollment: 68
• Est. completion date: March 2005
• Est. primary completion date: April 2004
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years to 120 Years

Eligibility

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

Study Design

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

Related Conditions & MeSH terms

• Head and Neck Cancer
• Head and Neck Neoplasms

Intervention

Drug:
• Induction chemotherapy
Cisplatin and 5-Fluorouracil
• cisplatin
Cisplatin 100 mg/m2 IV infusion over 90 minutes Day 1 every 21 days for 2 cycles.
• fluorouracil
5-Fluorouracil 1,000 mg/m2/day continuous IV infusion over 24 hours Days 1 through 5 every 21 days for 2 cycles.

Radiation:
• low-LET cobalt-60 gamma ray therapy
180 cGy per day, Days 1-5, every week for eight weeks

Locations

Country	Name	City	State
United States	University of Michigan Comprehensive Cancer Center	Ann Arbor	Michigan
United States	Veterans Affairs Medical Center - Ann Arbor	Ann Arbor	Michigan
United States	Veterans Affairs Medical Center - Brooklyn	Brooklyn	New York
United States	Cleveland Clinic Cancer Center	Cleveland	Ohio
United States	University of Colorado Cancer Center	Denver	Colorado
United States	Barbara Ann Karmanos Cancer Institute	Detroit	Michigan
United States	Henry Ford Hospital	Detroit	Michigan
United States	Veterans Affairs Medical Center - Detroit	Detroit	Michigan
United States	University of Texas Medical Branch	Galveston	Texas
United States	University of Kansas Medical Center	Kansas City	Kansas
United States	Veterans Affairs Medical Center - Kansas City	Kansas City	Missouri
United States	University of Arkansas for Medical Sciences	Little Rock	Arkansas
United States	USC/Norris Comprehensive Cancer Center	Los Angeles	California
United States	MBCCOP - LSU Medical Center	New Orleans	Louisiana
United States	Oklahoma Medical Research Foundation	Oklahoma City	Oklahoma
United States	Veterans Affairs Medical Center - Oklahoma City	Oklahoma City	Oklahoma
United States	CCOP - Scott and White Hospital	Temple	Texas
United States	Veterans Affairs Medical Center - Temple	Temple	Texas

Sponsors (2)

Lead Sponsor	Collaborator
Southwest Oncology Group	National Cancer Institute (NCI)

Country where clinical trial is conducted

United States, 

References & Publications (2)

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] Pr

Urba SG, Moon J, Giri PG, Adelstein DJ, Hanna E, Yoo GH, Leblanc M, Ensley JF, Schuller DE. Organ preservation for advanced resectable cancer of the base of tongue and hypopharynx: a Southwest Oncology Group Trial. J Clin Oncol. 2005 Jan 1;23(1):88-95. — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Complete response	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).	23 to 27 weeks after beginning treatment	No