Randomized, Double-Blind, Placebo-Controlled, Multi-Center Phase II Trial of Selenomethionine as a Modulator of Efficacy and Toxicity of Chemoradiation in Locally-Advanced Squamous Cell Carcinoma of the Head and Neck
18 Years
N/A
Both
Chemotherapeutic Agent Toxicity, Head and Neck Cancer, Mucositis, Radiation Toxicity, Xerostomia
Trial Information
Randomized, Double-Blind, Placebo-Controlled, Multi-Center Phase II Trial of Selenomethionine as a Modulator of Efficacy and Toxicity of Chemoradiation in Locally-Advanced Squamous Cell Carcinoma of the Head and Neck
OBJECTIVES:
Primary
- Assess whether selenomethionine (SLM) reduces the incidence of grade 3 or 4 mucositis
in patients with locally advanced squamous cell carcinoma of the head and neck treated
with concurrent cisplatin and radiotherapy over 7 weeks.
Secondary
- Assess the impact of SLM on tumor complete response rate, relapse-free survival,
overall survival, and quality of life of these patients.
- Assess whether SLM reduces the incidence and severity of treatment-related toxicities,
including xerostomia, renal impairment, and myelosuppression in these patients.
- Assess whether SLM improves chemoradiotherapy dose delivery in these patients.
- Determine the safety of SLM in these patients.
OUTLINE: This is a multicenter study. Patients are randomized to 1 of 2 treatment arms.
- Arm I: Patients receive oral placebo twice daily in week 1 and then once daily in weeks
2-11. Patients also receive cisplatin IV over 3 hours once in weeks 2, 5, and 8 and
undergo radiotherapy 5 days a week in weeks 2-8.
- Arm II: Patients receive oral selenomethionine twice daily in week 1 and then once
daily in weeks 2-11. Patients also receive cisplatin and radiotherapy as in arm I.
Patients complete quality-of-life questionnaires at baseline and then periodically
thereafter.
After completion of study therapy, patients are followed up periodically.
Inclusion Criteria
DISEASE CHARACTERISTICS:
- Histologically confirmed squamous cell carcinoma (SCC) of the head and neck,
including any of the following sites:
- Oral cavity
- Oropharynx
- Hypopharynx
- Larynx
- Nasopharynx
- Paranasal sinuses
- Locally advanced disease
- Stage III, IVa, or IVb disease
- No non-regional metastatic disease (stage IVc)
- Appropriate candidate for concurrent cisplatin and radiotherapy as definitive
treatment
- Patients who receive induction chemotherapy as part of a definitive treatment
program that will include concurrent cisplatin and radiotherapy are eligible
PATIENT CHARACTERISTICS:
- ECOG performance status 0-2
- ANC ≥ 2,000/mm^3
- Platelet count ≥ 100,000/mm^3
- Hemoglobin ≥ 10 g/dL
- Serum creatinine ≤ 1.5 mg/dL (133 μmol/L) OR creatinine clearance ≥ 50 mL/min
- Not pregnant or nursing
- Negative pregnancy test
- Fertile patients must use effective contraception
- Able to tolerate oral medications OR has a feeding tube in place
- Willing and able to comply with study procedures
- No other malignancy within the past 5 years except for adequately treated basal cell
or squamous cell carcinoma of the skin or cervical intra-epithelial neoplasia
- No known hepatitis C or HIV positivity
- No symptomatic peripheral neuropathy ≥ NCI-CTCAE grade 2
- No history of hypersensitivity to platinum drugs
- No concurrent uncontrolled illness including, but not limited to, any of the
following:
- Ongoing or active infection
- Symptomatic congestive heart failure
- Unstable angina pectoris
- Clinically significant cardiac arrhythmia
- Psychiatric illness or social situation that would limit compliance with study
requirements
- No evidence of any other significant medical disorder or laboratory finding that, in
the opinion of the investigator, would compromise the patient's safety during the
study
PRIOR CONCURRENT THERAPY:
- See Disease Characteristics
- No prior definitive surgery for SCC of the head and neck
- No prior radiotherapy for SCC of the head and neck
- No prior radiotherapy that would compromise delivery of a radical dose to SCC of the
head and neck
- No concurrent amifostine for prophylaxis against radiation-induced xerostomia
- No concurrent selenium supplements > 100 μg/day
- No other concurrent chemotherapy
- No concurrent hormonal therapy, except steroids for adrenal failure or septic shock,
hormones for non-disease-related conditions (e.g., insulin for diabetes or
L-thyroxine for hypothyroidism), or glucocorticosteroids as antiemetics
Type of Study:
Interventional
Study Design:
Allocation: Randomized, Intervention Model: Parallel Assignment, Masking: Double Blind (Subject, Investigator), Primary Purpose: Supportive Care
Outcome Measure:
Incidence of ≥ grade 3 mucositis
Outcome Time Frame:
1 year
Safety Issue:
Yes
Principal Investigator
Anurag Singh, MD
Investigator Role:
Principal Investigator
Investigator Affiliation:
Roswell Park Cancer Institute
Authority:
United States: Food and Drug Administration
Study ID:
CDR0000647812
NCT ID:
NCT00935038
Start Date:
June 2009
Completion Date:
Related Keywords:
- Chemotherapeutic Agent Toxicity
- Head and Neck Cancer
- Mucositis
- Radiation Toxicity
- Xerostomia
- mucositis
- xerostomia
- chemotherapeutic agent toxicity
- radiation toxicity
- stage III squamous cell carcinoma of the hypopharynx
- stage IV squamous cell carcinoma of the hypopharynx
- stage III squamous cell carcinoma of the larynx
- stage IV squamous cell carcinoma of the larynx
- stage III squamous cell carcinoma of the lip and oral cavity
- stage IV squamous cell carcinoma of the lip and oral cavity
- stage III squamous cell carcinoma of the nasopharynx
- stage IV squamous cell carcinoma of the nasopharynx
- stage III squamous cell carcinoma of the oropharynx
- stage IV squamous cell carcinoma of the oropharynx
- stage III squamous cell carcinoma of the paranasal sinus and nasal cavity
- stage IV squamous cell carcinoma of the paranasal sinus and nasal cavity
- Carcinoma, Squamous Cell
- Head and Neck Neoplasms
- Xerostomia
- Radiation Injuries
- Mucositis
Name | Location |
|---|---|
| Roswell Park Cancer Institute | Buffalo, New York 14263 |
