Trial Outcomes & Findings for Ph II Long Term/Low Dose Xeloda in Head and Neck Squamous Cell Carcinoma After Surgery, Radiation & or Chemo (NCT NCT00258310)

NCT ID: NCT00258310

Last Updated: 2023-03-10

Results Overview

Compliance is defined as taking at least 80% of the prescribed dose for one year.

• Recruitment status: COMPLETED
• Study phase: PHASE2
• Target enrollment: 35 participants
• Primary outcome timeframe: within 365 days
• Results posted on: 2023-03-10

Participant Flow

Participant milestones

Measure	Capecitabine Capecitabine 1000mg/day for one year capecitabine adjuvant therapy
Overall Study STARTED	35
Overall Study COMPLETED	35
Overall Study NOT COMPLETED	0

Reasons for withdrawal

Withdrawal data not reported

Baseline Characteristics

Ph II Long Term/Low Dose Xeloda in Head and Neck Squamous Cell Carcinoma After Surgery, Radiation & or Chemo

Baseline characteristics by cohort

Measure	Capecitabine n=35 Participants Capecitabine 1000mg/day for one year capecitabine adjuvant therapy
Age, Continuous	58 years n=5 Participants
Sex: Female, Male Female	7 Participants n=5 Participants
Sex: Female, Male Male	28 Participants n=5 Participants
Region of Enrollment United States	35 participants n=5 Participants

PRIMARY outcome

Timeframe: within 365 days

Compliance is defined as taking at least 80% of the prescribed dose for one year.

Outcome measures

Measure	Capecitabine n=35 Participants Capecitabine 1000mg/day for one year capecitabine adjuvant therapy
Compliance With Treatment .	74 percentage of participants Interval 59.0 to 90.0

SECONDARY outcome

Timeframe: Within 3 years of end of study.

Population: All enrolled participants

Time to recurrence or death

Outcome measures

Measure	Capecitabine n=34 Participants Capecitabine 1000mg/day for one year capecitabine adjuvant therapy
Recurrence-free Survival	NA months Median was not reached due to insufficient number of participants with events

SECONDARY outcome

Timeframe: Within 3 years of end of study

Population: Entire study population

Estimated time from study entry to death from any cause

Outcome measures

Measure	Capecitabine n=33 Participants Capecitabine 1000mg/day for one year capecitabine adjuvant therapy
Overall Survival	NA months Neither the median nor the 95% confidence interval can be calculated because there were too few deaths.

SECONDARY outcome

Timeframe: Within 3 years of end of study

Population: Entire study population

Outcome measures

Measure	Capecitabine n=35 Participants Capecitabine 1000mg/day for one year capecitabine adjuvant therapy
Incidence of Second Primary Tumors	3 Participants

Adverse Events

Capcitabine

Serious events: 2 serious events

Other events: 3 other events

Deaths: 0 deaths

Serious adverse events

Measure	Capcitabine n=35 participants at risk Capecitabine 1000mg/day for one year adjuvant therapy
Cardiac disorders Respiratory Failure	2.9% 1/35 • Number of events 1
General disorders Hand Foot Syndrome	5.7% 2/35 • Number of events 2

Other adverse events

Measure	Capcitabine n=35 participants at risk Capecitabine 1000mg/day for one year adjuvant therapy
Gastrointestinal disorders Nausea/vomiting	8.6% 3/35 • Number of events 3

Additional Information

George Yoo, M.D.

Barbara Ann Karmanos Institute

Phone: (313) 576-9782

Email: yoog@karmanos.org

Results disclosure agreements

• Principal investigator is a sponsor employee
• Publication restrictions are in place