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A Phase III Randomized Trial Comparing Single Agent Cisplatin With the Combination of 5-Fluorouracil and Cisplatin, Concurrent With Radiation Therapy in Stage III and IV Squamous Cell Head and Neck Cancer


Phase 3
18 Years
N/A
Open (Enrolling)
Both
Head and Neck Cancer

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Trial Information

A Phase III Randomized Trial Comparing Single Agent Cisplatin With the Combination of 5-Fluorouracil and Cisplatin, Concurrent With Radiation Therapy in Stage III and IV Squamous Cell Head and Neck Cancer


OBJECTIVES:

- To compare the relapse-free survival of patients treated with radiotherapy and
cisplatin with vs without fluorouracil.

- To compare the overall survival, local control without surgery, and patterns of failure
in patients treated with these regimens.

- To compare the acute and long-term toxicity of these regimens in these patients.

- To compare the quality of life of patients treated with these regimens.

- To prospectively collect biopsy material, mucosal scrapings, and serum in an effort to
generate hypotheses for future correlative studies.

OUTLINE: This is a multicenter study. Patients are stratified according to radiotherapy
schedule (once daily vs twice daily) and radiotherapy planning (2D vs 3D vs
intensity-modulated radiotherapy). Patients are randomized to 1 of 2 treatment arms.

- Arm I: Patients undergo full-dose radiotherapy once or twice daily 5 days a week for up
to 7 weeks and receive cisplatin IV over 1 hour on days 1, 22, and 43 of radiotherapy.

- Arm II: Patients undergo radiotherapy as in arm I and receive fluorouracil IV and
cisplatin IV continuously on days 1-4 and 22-25 of radiotherapy.

Patients with biopsy-verified residual disease at the primary site or local recurrence after
achieving a complete response to chemoradiotherapy may undergo salvage surgery 12 weeks
after the completion of chemoradiotherapy.

Patients complete questionnaires periodically to assess late toxicity and quality of life.

After completion of study treatment, patients are followed periodically.

Inclusion Criteria


DISEASE CHARACTERISTICS:

- Histologically confirmed squamous cell carcinoma of the oral cavity, oropharynx,
larynx, or hypopharynx

- No histologic diagnosis other than squamous cell carcinoma

- A primary site must be identified

- Must have locoregionally confined stage III (excluding T1-2, N1) or stage IV disease

- No evidence of nodal disease below the clavicles or distant hematogenous
metastases (M0)

- No stage IVC disease (stage IVB disease allowed)

- Deemed appropriate for definitive non-operative management with curative intent

- Resectable disease is not required

- No primary cancer of the nasopharynx, paranasal sinus, or salivary gland

PATIENT CHARACTERISTICS:

- ECOG performance status 0-1

- WBC > 3,500/mm³

- Platelet count > 100,000/mm³

- Serum creatinine < 2.0 mg/dL

- Alkaline phosphatase < 2 times normal

- AST < 2 times normal

- Bilirubin ≤ 2.0 mg/dL

- Serum calcium normal

- Not pregnant or nursing

- Negative pregnancy test

- Fertile patients must use effective contraception

- No unstable or uncontrolled angina

- No clinically apparent jaundice

- No active infection

- No history of any other malignancy (except squamous cell or basal cell skin cancer or
cervical carcinoma in situ), unless the patient has been continuously disease-free
for at least 5 years

- Not a poor compliance risk

- Able to withstand the rigors of intensive treatment

- Available for and compliant with adequate long-term follow-up

PRIOR CONCURRENT THERAPY:

- No prior definitive surgery or radiotherapy for this malignancy

- No prior chemotherapy, immunotherapy, or epidermal growth factor receptor inhibitors
for any disease Patients who have had previous definitive surgery, or radiation
therapy for this malignancy, and patients who have had any previous chemotherapy,
immunotherapy, or EGF receptor inhibition for any disease are ineligible.

Exclusion Criteria Patients with primary cancers of the nasopharynx, paranasal sinus or
salivary gland are ineligible.

Patients with unstable or uncontrolled angina, clinically apparent jaundice, or active
infection are ineligible.

Patients with a history of any other malignancy (except squamous or basal cell skin cancer
or cervical carcinoma in-situ) are ineligible, unless the patient has been continuously
disease-free for at least 5 years.

Patients with any histologic diagnosis other than squamous cell carcinoma are ineligible.

Patients who might be a poor-compliance risk are ineligible.

Pregnant or breastfeeding women are ineligible. Women/men of reproductive potential must
be willing to practice acceptable methods of birth control to prevent pregnancy.

Type of Study:

Interventional

Study Design:

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

Outcome Measure:

Clinical Response-complete disappearance of detectable tumor

Outcome Description:

Twelve weeks after completing chemoradiotherapy, a formal evaluation for response will be made, to include a careful evaluation by the head and neck surgeon, medical and radiation oncologists, and, as appropriate, a radiologic and an endoscopic examination. Patients will be considered to have achieved either a clinical complete response (i.e. complete disappearance of all clinically and radiologically detectable tumor) or to have clinical persistent disease.

Outcome Time Frame:

at 12 weeks after completing chemoradiotherapy

Safety Issue:

No

Principal Investigator

David J. Adelstein, MD

Investigator Role:

Principal Investigator

Investigator Affiliation:

Cleveland Clinic Taussig Cancer Institute, Case Comprehensive Cancer Center

Authority:

United States: Food and Drug Administration

Study ID:

CASE3307

NCT ID:

NCT00608205

Start Date:

January 2008

Completion Date:

Related Keywords:

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

Name

Location

Case Medical Center, University Hospitals Seidman Cancer Center, Case Comprehensive Cancer CenterCleveland, Ohio  44106-5065
Cleveland Clinic Taussig Cancer Institute, Case Comprehensive Cancer CenterCleveland, Ohio  44195