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

NCT00002735 | Terminated Phase 2 DMC

• 3 other identifiers: CDR0000064634SWOG-9451U10CA032102
• Study Type: interventional
• Target: 68
• Locations: 1 country
• Sites: 18

Brief 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.

Conditions

Head and Neck Cancer

Keywords

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

Outcome Measures

Primary Outcomes (1)

• 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

Study Arms (1)

Treatment arm

EXPERIMENTAL

induction chemotherapy followed by chemoradiation

Drug: Induction chemotherapy; Drug: cisplatin; Drug: fluorouracil; Radiation: low-LET cobalt-60 gamma ray therapy

Interventions

Induction chemotherapy DRUG

Cisplatin and 5-Fluorouracil

Also known as: platinol, 5-FU

Treatment arm

cisplatin DRUG

Cisplatin 100 mg/m2 IV infusion over 90 minutes Day 1 every 21 days for 2 cycles.

Also known as: platinol

Treatment arm

fluorouracil DRUG

5-Fluorouracil 1,000 mg/m2/day continuous IV infusion over 24 hours Days 1 through 5 every 21 days for 2 cycles.

Also known as: 5-FU

Treatment arm

low-LET cobalt-60 gamma ray therapy RADIATION

180 cGy per day, Days 1-5, every week for eight weeks

Also known as: RT

Treatment arm

Eligibility Criteria

• Age: 18 Years - 120 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

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

Contact the study team to discuss eligibility requirements. They can help determine if this study is right for you.

Sponsors & Collaborators

• SWOG Cancer Research Network: lead
• National Cancer Institute (NCI): collaborator

Study Sites (18)

University of Arkansas for Medical Sciences

Little Rock, Arkansas, 72205, United States

Location

USC/Norris Comprehensive Cancer Center

Los Angeles, California, 90033-0800, United States

Location

University of Colorado Cancer Center

Denver, Colorado, 80262, United States

Location

University of Kansas Medical Center

Kansas City, Kansas, 66160-7357, United States

Location

MBCCOP - LSU Medical Center

New Orleans, Louisiana, 70112, United States

Location

Veterans Affairs Medical Center - Ann Arbor

Ann Arbor, Michigan, 48105, United States

Location

University of Michigan Comprehensive Cancer Center

Ann Arbor, Michigan, 48109-0752, United States

Location

Veterans Affairs Medical Center - Detroit

Detroit, Michigan, 48201-1932, United States

Location

Barbara Ann Karmanos Cancer Institute

Detroit, Michigan, 48201, United States

Location

Henry Ford Hospital

Detroit, Michigan, 48202, United States

Location

Veterans Affairs Medical Center - Kansas City

Kansas City, Missouri, 64128, United States

Location

Veterans Affairs Medical Center - Brooklyn

Brooklyn, New York, 11209, United States

Location

Cleveland Clinic Cancer Center

Cleveland, Ohio, 44195, United States

Location

Oklahoma Medical Research Foundation

Oklahoma City, Oklahoma, 73104, United States

Location

Veterans Affairs Medical Center - Oklahoma City

Oklahoma City, Oklahoma, 73104, United States

Location

University of Texas Medical Branch

Galveston, Texas, 77555-1329, United States

Location

Veterans Affairs Medical Center - Temple

Temple, Texas, 76504, United States

Location

CCOP - Scott and White Hospital

Temple, Texas, 76508, United States

Location

Related Publications (2)

• 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. doi: 10.1200/JCO.2005.04.017.

  PMID: 15625363 RESULT

• 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.

  RESULT

MeSH Terms

Conditions

Head and Neck Neoplasms; Squamous Cell Carcinoma of Head and Neck

Interventions

Induction Chemotherapy; Cisplatin; Fluorouracil

Condition Hierarchy (Ancestors)

Neoplasms by Site; Neoplasms; Carcinoma, Squamous Cell; Carcinoma; Neoplasms, Glandular and Epithelial; Neoplasms by Histologic Type

Intervention Hierarchy (Ancestors)

Drug Therapy; Therapeutics; Remission Induction; Chlorine Compounds; Inorganic Chemicals; Nitrogen Compounds; Platinum Compounds; Uracil; Pyrimidinones; Pyrimidines; Heterocyclic Compounds, 1-Ring; Heterocyclic Compounds

Study Officials

• Susan G. Urba, MD

  University of Michigan Rogel Cancer Center

  STUDY CHAIR

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: NETWORK
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: November 1, 1999
• First Posted: September 1, 2004
• Study Start: April 1, 1996
• Primary Completion: April 1, 2004
• Study Completion: March 1, 2005
• Last Updated: September 30, 2015

Record last verified: 2015-09

Locations

US (18)