TerminatedPhase 3

Palifermin in Lessening Oral Mucositis in Patients Undergoing Radiation Therapy and Chemotherapy for Locally Advanced Head and Neck Cancer

Stopped: Due to positive preliminary results from other palifermin studies.

United States21 participantsStarted 2006-07

Plain-language summary

RATIONALE: Growth factors, such as palifermin, may lessen the severity of mucositis, or mouth sores, in patients receiving radiation therapy and chemotherapy for head and neck cancer. It is not yet known whether palifermin is more effective than a placebo in lessening mucositis in patients receiving radiation therapy and chemotherapy for head and neck cancer. PURPOSE: This randomized phase III trial is studying palifermin to see how well it works compared to a placebo in lessening oral mucositis in patients undergoing radiation therapy and chemotherapy for locally advanced head and neck cancer.

Who can participate

Age range18 Years

SexALL

See this in plain English?

AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.

Inclusion criteria

✓. Pathologically (histologically or cytologically) proven (from primary lesion and/or lymph nodes) diagnosis of squamous cell carcinoma of the oral cavity, oropharynx, hypopharynx, or larynx;
✓. Patients must have at least 2 mucosal sites of the oral cavity/oropharynx mucosa assessable by visual transoral inspection that will receive at least 66 Gy;
✓2.1 Patients with tumors of the larynx or hypolarynx are eligible only if it is anticipated that the 2 index sites in the oral cavity/oropharynx mucosa will receive at least 66 Gy;
✓. Patients must be able to be evaluated for the primary endpoint; therefore, patients must be able to eat at least soft solids and not require a feeding tube for nutrition or hydration at study entry.
✓. Selected Stage III (excluding T1N1MO) or IVA-B (AJCC, 6th edition) at study entry, including no distant metastases, based upon the following minimum diagnostic workup:
✓. Zubrod Performance Status 0-1;
✓. Age \> 18;
✓. Adequate bone marrow function, defined as follows:

Exclusion criteria

What they're measuring

Duration of Oral Mucositis as Measured in Terms of Days

Timeframe: Twice-weekly from start of treatment up to 15 weeks after the start of treatment.

Trial details

NCT IDNCT00360971

SponsorRadiation Therapy Oncology Group

Sponsor typeNETWORK

Study typeINTERVENTIONAL

Primary completion2008-05

Results submitted2014-04-16

View on ClinicalTrials.gov More Head and Neck Cancer trials