|
|
Home
Search
Study Topics
Glossary
|
 |
|
|
|
|
|
|
|
|
|
|
|
|
||||||||||||||||||||||||||||||||||||
| Sponsor: | Jonsson Comprehensive Cancer Center |
|---|---|
| Collaborator: |
National Cancer Institute (NCI) |
| Information provided by: | National Cancer Institute (NCI) |
| ClinicalTrials.gov Identifier: | NCT00022373 |
Purpose
RATIONALE: Iseganan hydrochloride may be effective in preventing or lessening oral mucositis in patients who are receiving radiation therapy for head and neck cancer. It is not yet known if iseganan hydrochloride is effective in preventing oral mucositis.
PURPOSE: Randomized phase III trial to determine the effectiveness of iseganan hydrochloride in preventing oral mucositis in patients who are receiving radiation therapy for head and neck cancer.
| Condition | Intervention | Phase |
|---|---|---|
|
Head and Neck Cancer Oral Complications of Radiation Therapy Radiation Toxicity |
Drug: iseganan HCl oral solution Procedure: management of therapy complications |
Phase III |
| Study Type: | Interventional |
| Study Design: | Primary Purpose: Supportive Care |
| Official Title: | A Multinational, Multicenter, Double-Blind, Placebo-Controlled, Randomized, Phase III Clinical Trial to Determine the Efficacy and Safety of IB-367 Rinse in Reducing the Severity of Oral Mucositis in Patients Receiving Radiotherapy for Head and Neck Malignancy |
| Study Start Date: | December 2000 |
OBJECTIVES: I. Compare the efficacy and safety of iseganan HCl oral solution vs placebo in patients undergoing radiotherapy with or without chemotherapy for head and neck cancer. II. Compare the effects of these treatments on mouth pain, ability to swallow, weight loss, and the distribution of oral mucositis in these patients.
OUTLINE: This is a randomized, double-blind, placebo-controlled, multicenter study. Patients are stratified according to radiotherapy (conventional fractionating radiotherapy vs hyperfractionating or concurrent boost radiotherapy) and concurrent chemotherapy (yes vs no). Patients are randomized to 1 of 3 arms. Arm I: Patients rinse with iseganan HCl oral solution 6 times daily. Treatment continues for the duration of the scheduled radiotherapy. Arm II: Patients rinse with oral placebo 6 times daily. Treatment continues for the duration of the scheduled radiotherapy. Arm III: Patients receive standard-of-care supportive treatment. Oral cavity pain, ability to swallow, and weight loss are assessed twice weekly and on follow-up days 28 and 56. Patients are followed on days 28 and 56.
PROJECTED ACCRUAL: A total of 504 patients (252 for arm I, 168 for arm II, and 84 for arm III) will be accrued for this study.
Eligibility| Ages Eligible for Study: | 18 Years and older |
| Genders Eligible for Study: | Both |
| Accepts Healthy Volunteers: | No |
DISEASE CHARACTERISTICS: Histologically confirmed malignancy of the head and neck, including cancer of the oral cavity, oropharynx, nasopharynx, hypopharynx, or salivary glands Undergoing or planning to undergo radiotherapy to the head and neck involving: Bilateral treatment with either conventional, hyperfractionated, or concurrent boost external beam radiotherapy Minimum total radiation dose of 60 Gy to at least 3 sites within the oral cavity Total scheduled administration of no more than 8 weeks No oral mucositis already present Ulceration related to head and neck malignancy or prior surgery allowed
PATIENT CHARACTERISTICS: Age: 18 and over Performance status: Not specified Life expectancy: Not specified Hematopoietic: Not specified Hepatic: Not specified Renal: Not specified Other: Must be able to orally rinse with study drug Not pregnant or nursing Negative pregnancy test Fertile patients must use effective contraception
PRIOR CONCURRENT THERAPY: Biologic therapy: Not specified Chemotherapy: Concurrent chemotherapy allowed Endocrine therapy: No concurrent topical corticosteroids to oral cavity Radiotherapy: See Disease Characteristics Surgery: See Disease Characteristics Other: At least 30 days since prior investigational agent for prevention and/or treatment of mucositis No prior participation in this study No concurrent topical anesthetics, such as lidocaine or dyclonine hydrochloride, within 30 minutes before or 15 minutes after study agent No concurrent oral rinses within 15 minutes of study agent
Contacts and Locations| United States, California | |
| Jonsson Comprehensive Cancer Center, UCLA | |
| Los Angeles, California, United States, 90095-1781 | |
| Study Chair: | Guy J. F. Juillard, MD | Jonsson Comprehensive Cancer Center |
More Information
| ClinicalTrials.gov Identifier: | NCT00022373 History of Changes |
| Other Study ID Numbers: | CDR0000068810, UCLA-0008049, IBP-PG-015, NCI-G01-2001 |
| Study First Received: | August 10, 2001 |
| Last Updated: | May 9, 2009 |
| Health Authority: | United States: Federal Government |
|
stage I nasopharyngeal cancer stage II nasopharyngeal cancer stage III nasopharyngeal cancer stage IV nasopharyngeal cancer stage I salivary gland cancer stage II salivary gland cancer stage III salivary gland cancer stage IV salivary gland cancer recurrent salivary gland cancer untreated metastatic squamous neck cancer with occult primary recurrent metastatic squamous neck cancer with occult primary stage I lip and oral cavity cancer stage II lip and oral cavity cancer |
stage III lip and oral cavity cancer stage IV lip and oral cavity cancer stage I hypopharyngeal cancer stage II hypopharyngeal cancer stage III hypopharyngeal cancer stage IV hypopharyngeal cancer stage I oropharyngeal cancer stage II oropharyngeal cancer stage III oropharyngeal cancer stage IV oropharyngeal cancer radiation toxicity oral complications of radiation therapy |
|
Head and Neck Neoplasms Stomatitis Radiation Injuries Mucositis Neoplasms by Site Neoplasms |
Mouth Diseases Stomatognathic Diseases Wounds and Injuries Gastroenteritis Gastrointestinal Diseases Digestive System Diseases |
