Trial Outcomes & Findings for Amifostine With IMRT for Submandibular and Sublingual Salivary Sparing During Head and Neck Cancer Treatment (NCT NCT00409331)

Results Overview

Primary endpoint is bilateral, 12-month Clinically Relevant Salivary Flow (CRSF) by the submandibular and sublingual salivary glands, collectively. Saliva production will be quantified using selective quantitative submandibular sialometry (total collection time of 5 minutes). A CRSF is equivalent to production of 0.05 mL of saliva post-radiation in a 5-minute collection period.

Recruitment status

TERMINATED

Study phase

PHASE2

Target enrollment

3 participants

Primary outcome timeframe

12 months

Results posted on

2012-08-07

Participant Flow

Recruitment Period: 06/12/07 through 01/14/08. All participants recruited at UT MD Anderson Cancer Center.

Study terminated due to slow accrual and change in sponsor. Three patients registered, two removed prior to study beginning as not eligible.

Participant milestones

Participant milestones
Measure	IMRT + Amifostine Intensity-Modulated Radiation Therapy (IMRT) 2.0 to 2.2 Gy delivered in 30 fractions + Amifostine 500 mg, 2 divided doses subcutaneously 30-60 minutes prior to IMRT.
Overall Study STARTED	1
Overall Study COMPLETED	0
Overall Study NOT COMPLETED	1

Reasons for withdrawal

Reasons for withdrawal
Measure	IMRT + Amifostine Intensity-Modulated Radiation Therapy (IMRT) 2.0 to 2.2 Gy delivered in 30 fractions + Amifostine 500 mg, 2 divided doses subcutaneously 30-60 minutes prior to IMRT.
Overall Study Physician Decision	1

Baseline Characteristics

Amifostine With IMRT for Submandibular and Sublingual Salivary Sparing During Head and Neck Cancer Treatment

Baseline characteristics by cohort

Baseline characteristics by cohort
Measure	IMRT + Amifostine n=1 Participants Intensity-Modulated Radiation Therapy (IMRT) 2.0 to 2.2 Gy delivered in 30 fractions + Amifostine 500 mg, 2 divided doses subcutaneously 30-60 minutes prior to IMRT.
Age Continuous	48 years n=5 Participants
Sex: Female, Male Female	0 Participants n=5 Participants
Sex: Female, Male Male	1 Participants n=5 Participants
Region of Enrollment United States	1 participants n=5 Participants

PRIMARY outcome

Timeframe: 12 months

Population: No analysis performed; study terminated early due to change in sponsor.

Primary endpoint is bilateral, 12-month Clinically Relevant Salivary Flow (CRSF) by the submandibular and sublingual salivary glands, collectively. Saliva production will be quantified using selective quantitative submandibular sialometry (total collection time of 5 minutes). A CRSF is equivalent to production of 0.05 mL of saliva post-radiation in a 5-minute collection period.

Outcome measures

Outcome data not reported

Adverse Events

IMRT + Amifostine

Serious events: 0 serious events

Other events: 0 other events

Deaths: 0 deaths

Serious adverse events

Adverse event data not reported

Other adverse events

Adverse event data not reported

Additional Information

Mark Chambers, DMD / Associate Professor

UT MD Anderson Cancer Center

Phone: 713-745-2672

Results disclosure agreements

Principal investigator is a sponsor employee
Publication restrictions are in place