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A Phase III Trial for Locally Recurrent, Previously Irradiated Head and Neck Cancer: Concurrent Re-Irradiation and Chemotherapy Versus Chemotherapy Alone

Phase 3
18 Years
Not Enrolling
Head and Neck Cancer

Thank you

Trial Information

A Phase III Trial for Locally Recurrent, Previously Irradiated Head and Neck Cancer: Concurrent Re-Irradiation and Chemotherapy Versus Chemotherapy Alone



- Compare overall survival of patients with previously irradiated unresectable locally
recurrent squamous cell carcinoma of the head and neck treated with radiotherapy,
cisplatin, and paclitaxel vs cisplatin-based chemotherapy alone.


- Compare progression-free survival of patients treated with these regimens.

- Compare the toxicity of these regimens in these patients.

- Compare quality of life, functional/performance status, and quality-adjusted survival
of patients treated with these regimens.

OUTLINE: This is a randomized, multicenter study. Patients are randomized to 1 of 2
treatment arms.

- Arm I: Patients undergo radiotherapy twice daily and receive paclitaxel IV over 1 hour
and cisplatin IV over 30 minutes once daily on days 1-5, 15-19, 29-33, and 43-47.
Patients also receive filgrastim (G-CSF) subcutaneously once daily on days 6-13, 20-27,
34-41, and 48-55.

- Arm II: Patients receive 1 of the following cisplatin-based* regimens at the discretion
of the treating physician:

- Regimen 1: Patients receive cisplatin* IV over 1-2 hours on day 1 and fluorouracil
IV continuously over 96 hours on days 1-4.

- Regimen 2: Patients receive cisplatin* IV over 1-2 hours and paclitaxel IV over 3
hours on day 1.

- Regimen 3: Patients receive cisplatin* IV over 1-2 hours and docetaxel IV over 1
hour on day 1.

NOTE: *Carboplatin may be substituted for cisplatin in patients with creatinine clearance <
50 mL/min or in patients who experience grade 2 or 3 neurotoxicity.

For all regimens, treatment repeats every 21 days for at least 6 courses in the absence of
disease progression or unacceptable toxicity. Patients achieving complete response (CR)
receive 2 additional courses beyond documentation of CR.

Quality of life is assessed at baseline and then at 3, 6, 12, 24, and 36 months.

After completion of study treatment, patients are followed every 3 months for 2 years, every
6 months for 3 years, and then annually thereafter.

PROJECTED ACCRUAL: A total of 240 patients (120 per treatment arm) will be accrued for this
study within 5½ years.

Inclusion Criteria


- Histologically* or cytologically* confirmed squamous cell carcinoma (SCC) of the oral
cavity, oropharynx, hypopharynx, or larynx, including any of the following histologic

- Spindle cell carcinoma

- Poorly differentiated keratin-positive carcinoma

- Lymphoepithelioma NOTE: *Biopsy or primary tumor and/or fine needle aspiration
of the metastatic lymph node required

- Original or second primary tumor

- Recurrent neck metastases with unknown primary allowed

- Locally recurrent disease

- Measurable disease

- Unresectable disease

- Attempted surgical resection allowed provided surgery was performed ≥ 3 months
ago, wound is completely healed, and there is no sign of carotid exposure

- Must have had prior radiotherapy for SCC of the head and neck with > 75% of the
present tumor volume in areas irradiated at doses ≥ 45 Gy but ≤ 75 Gy

- Able to successfully re-irradiate the area of the gross tumor volume without
exceeding lifetime spinal cord dose of 54 Gy as determined by physical
examination and CT scan and/or MRI performed within the past 8 weeks

- First recurrence occurred > 6 months after completion of radiotherapy

- More than 1 recurrence allowed provided the above criteria for first
recurrence has been met

- No primary tumor of the nasopharynx or salivary gland

- No distant metastases by history or physical examination, chest CT scan, and CT scan
or MRI of the tumor site

- Patients with equivocal pulmonary nodules are eligible provided the nodules are
< 1 cm, can be safely biopsied, or are negative by positron emission tomography

- No circumferential tumor involvement of the carotid sheath by imaging unless
prophylactic carotid stent is placed



- 18 and over

Performance status

- Zubrod 0-1

Life expectancy

- Not specified


- Absolute neutrophil count ≥ 1,800/mm³

- Platelet count ≥ 100,000/mm³

- Hemoglobin ≥ 8.0 g/dL (transfusion or other intervention allowed)


- AST or ALT < 2 times upper limit of normal (ULN)

- Bilirubin < 1.5 mg/dL

- No hepatic insufficiency resulting in clinical jaundice and/or coagulation defects


- Creatinine clearance > 50 mL/min

- Calcium < 11.5 mg/dL


- No New York Heart Association class III or IV heart disease

- No other symptomatic or uncontrolled cardiac disease


- No chronic obstructive pulmonary disease exacerbation

- No other respiratory illness requiring hospitalization within the past 6 months or
that would preclude study therapy



- No prior allergic reaction to E. coli-derived products

- No acute bacterial or fungal infection requiring IV antibiotics


- Not pregnant or nursing

- Negative pregnancy test

- Fertile patients must use effective contraception during and for 30 days after
completion of study treatment

- No other invasive malignancy within the past 3 years except nonmelanoma skin cancer,
carcinoma in situ of the breast, oral cavity, or cervix

- No pre-existing peripheral sensory neuropathy > grade 2

- No other severe active co-morbidity


Biologic therapy

- Not specified


- At least 6 months since prior chemotherapy

- No prior systemic chemotherapy for recurrent SCC of the head and neck

- Prior neoadjuvant, adjuvant, and/or concurrent chemotherapy and radiotherapy for
initial SCC of the head and neck allowed

Endocrine therapy

- Not specified


- See Disease Characteristics

- See Chemotherapy

- At least 6 months since prior radiotherapy


- See Disease Characteristics


- Prior cyclooxygenase-2 inhibitor or retinoids for chemoprevention allowed

- At least 6 months since prior epidermal growth factor receptor (EGFR) inhibitors or
other targeted agents

- No prior EGFR inhibitors or other targeted agents for recurrent SCC of the head and

- No concurrent cimetidine or allopurinol (for patients on arm II, regimen 1)

Type of Study:


Study Design:

Allocation: Randomized, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Treatment

Outcome Measure:

Overall Survival

Outcome Time Frame:

Date of death or last follow-up

Safety Issue:


Principal Investigator

Stuart J. Wong, MD

Investigator Role:

Principal Investigator

Investigator Affiliation:

Medical College of Wisconsin


United States: Federal Government

Study ID:




Start Date:

April 2005

Completion Date:

Related Keywords:

  • Head and Neck Cancer
  • recurrent squamous cell carcinoma of the hypopharynx
  • recurrent squamous cell carcinoma of the larynx
  • recurrent squamous cell carcinoma of the lip and oral cavity
  • recurrent squamous cell carcinoma of the oropharynx
  • recurrent metastatic squamous neck cancer with occult primary
  • recurrent lymphoepithelioma of the oropharynx
  • Head and Neck Neoplasms



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