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Phase II Study of Arginine/Omega-3 Fatty Acids/Nucleotides Oral Supplement (Oral IMPACT®) in Patients With Stage III or IV Epidermoid Head and Neck Cancer Undergoing Adjuvant Chemoradiotherapy

Alternate Title
Basic Trial Information
Objectives
Entry Criteria
Expected Enrollment
Outcomes
Outline
Trial Contact Information
Registry Information

Alternate Title

Arginine/Omega-3 Fatty Acids/Nucleotides Nutritional Supplement in Treating Patients With Stage III or Stage IV Head and Neck Cancer Undergoing Chemotherapy and Radiation Therapy

Basic Trial Information

Phase Type Status Age Sponsor Protocol IDs
Phase II Treatment Closed 18 and over Other CLCC-IMPACT-RT
INCA-RECF0286, IMPACT RT, NCT00559156

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.

Entry 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

Prior/Concurrent Therapy:

See Disease Characteristics

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

Expected Enrollment

Outcomes

Primary Outcome(s)

Effects of immunomodulator arginine/omega-3 fatty acids/nucleotides oral supplement (Oral IMPACT®) administered via percutaneous gastrostomy during adjuvant chemoradiotherapy

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.

Trial Contact Information

Trial Lead Organizations

Centre Regional de Lutte Contre le Cancer - Centre Val d'Aurelle

Pierre Senesse, MD, Protocol chair
Ph: 33-4-6761-3100

Registry Information

Official Title		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

Trial Start Date		2005-06-01

Registered in ClinicalTrials.gov		NCT00559156

Date Submitted to PDQ		2007-10-18

Information Last Verified		2007-11-14

Note: The purpose of most clinical trials listed in this database is to test new cancer treatments, or new methods of diagnosing, screening, or preventing cancer. Because all potentially harmful side effects are not known before a trial is conducted, dose and schedule modifications may be required for participants if they develop side effects from the treatment or test. The therapy or test described in this clinical trial is intended for use by clinical oncologists in carefully structured settings, and may not prove to be more effective than standard treatment. A responsible investigator associated with this clinical trial should be consulted before using this protocol.