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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


Phase 3
18 Years
N/A
Open (Enrolling)
Both
Head and Neck Cancer, Oral Complications of Radiation Therapy, Radiation Toxicity

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Trial Information

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


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.

Inclusion Criteria


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

Type of Study:

Interventional

Study Design:

Primary Purpose: Supportive Care

Principal Investigator

Guy J. F. Juillard, MD

Investigator Role:

Study Chair

Investigator Affiliation:

Jonsson Comprehensive Cancer Center

Authority:

United States: Federal Government

Study ID:

CDR0000068810

NCT ID:

NCT00022373

Start Date:

December 2000

Completion Date:

Related Keywords:

  • Head and Neck Cancer
  • Oral Complications of Radiation Therapy
  • Radiation Toxicity
  • 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

Name

Location

Jonsson Comprehensive Cancer Center, UCLALos Angeles, California  90095-1781