Phase 2 Study Assessing the Impact of Parenteral Administration of the Immunomodulater Oral IMPACT® for Postoperative Radiochemotherapy in Patients With Carcinoma of the Head and Neck
18 Years
N/A
Both
Head and Neck Cancer
Trial Information
Phase 2 Study Assessing the Impact of Parenteral Administration of the Immunomodulater Oral IMPACT® for Postoperative Radiochemotherapy in Patients With Carcinoma of the Head and Neck
OBJECTIVES:
- Assess the effects of immunomodulator arginine/omega-3 fatty acids/nucleotides oral
supplement (Oral IMPACT®) administered via percutaneous gastrostomy during adjuvant
chemoradiotherapy in patients with stage III or IV epidermoid head and neck cancer.
OUTLINE: This is a multicenter study.
Patients undergo radiotherapy 5 days a week for 6½ weeks. Patients receive cisplatin IV
during weeks 1, 4, and 7 of radiotherapy. Patients also receive arginine/omega-3 fatty
acids/nucleotides oral supplement (Oral IMPACT®) via percutaneous gastrostomy tube 3 times
daily for 5 days before each chemotherapy treatment.
Inclusion Criteria
DISEASE CHARACTERISTICS:
- Diagnosis of head and neck cancer meeting the following criteria:
- Epidermoid carcinoma
- Stage III or IV disease
- Must have percutaneous gastrostomy tube in place
- Must have undergone prior surgery for head and neck cancer within the past 6-8 weeks
- No cerebral metastases
PATIENT CHARACTERISTICS:
- WHO performance status (PS) 0-2 OR Karnofsky PS 60-100%
- Life expectancy > 3 months
- WBC > 4,000/mm³
- ANC > 2,000/mm³
- Platelet count > 100,000/mm³
- PTT ≥ 50%
- Creatinine < 130 μmol/L
- Not pregnant or nursing
- Fertile patients must use effective contraception
- No severe sepsis
- No requirement for parenteral nutrition
- No pre-existing digestive pathology that results in bowel obstruction, nausea,
vomiting, and/or abdominal pain > grade 1
PRIOR CONCURRENT THERAPY:
- See Disease Characteristics
Type of Study:
Interventional
Study Design:
Allocation: Non-Randomized, Primary Purpose: Treatment
Outcome Measure:
Effects of immunomodulator arginine/omega-3 fatty acids/nucleotides oral supplement (Oral IMPACT®) administered via percutaneous gastrostomy during adjuvant chemoradiotherapy
Safety Issue:
No
Principal Investigator
Pierre Senesse, MD
Investigator Role:
Study Chair
Investigator Affiliation:
Centre Val d'Aurelle - Paul Lamarque
Authority:
United States: Federal Government
Study ID:
CDR0000574125
NCT ID:
NCT00559156
Start Date:
June 2005
Completion Date:
Related Keywords:
- Head and Neck Cancer
- recurrent squamous cell carcinoma of the hypopharynx
- 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
- recurrent squamous cell carcinoma of the larynx
- recurrent squamous cell carcinoma of the lip and oral cavity
- stage III squamous cell carcinoma of the lip and oral cavity
- stage IV squamous cell carcinoma of the lip and oral cavity
- metastatic squamous neck cancer with occult primary squamous cell carcinoma
- recurrent metastatic squamous neck cancer with occult primary
- recurrent squamous cell carcinoma of the nasopharynx
- stage III squamous cell carcinoma of the nasopharynx
- stage IV squamous cell carcinoma of the nasopharynx
- recurrent squamous cell carcinoma of the oropharynx
- stage III squamous cell carcinoma of the oropharynx
- stage IV squamous cell carcinoma of the oropharynx
- recurrent squamous cell carcinoma of the paranasal sinus and nasal cavity
- stage III squamous cell carcinoma of the paranasal sinus and nasal cavity
- stage IV squamous cell carcinoma of the paranasal sinus and nasal cavity
- recurrent salivary gland cancer
- salivary gland squamous cell carcinoma
- stage III salivary gland cancer
- stage IV salivary gland cancer
- Head and Neck Neoplasms
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