Trial Outcomes & Findings for Stereotactic Body Radiation Therapy in Treating Patients With High Risk Locally Advanced Head and Neck Cancer (NCT NCT02388932)

Results Overview

Maximum tolerated dose of SBRT in this patient population determined by the dose escalation design with doses '40Gy' and '45Gy all in 5 fractions'.

Recruitment status

TERMINATED

Study phase

NA

Target enrollment

3 participants

Primary outcome timeframe

3 months

Results posted on

2019-01-24

Participant Flow

Participant milestones

Participant milestones
Measure	Treatment (SBRT) Participants undergo Stereotactic Body Radiation Therapy in 5 fractions at least 40 hours apart over 10-18 days. Three dose levels: 40Gy and 45Gy all in 5 fractions. Each initial dose level will have 6 participants allocated to them. All participants are assessed at their 3 month post SBRT visit for Dose-Limiting Toxicities (DLTs). If ≤1 participant experiences a DLT, participants will be enrolled at the next dose level. If ≥3 participants experience a DLT, further accrual will be permanently halted and the study stopped. If 2 participants experience a DLT, then an additional 6 participants will be enrolled at the same dose level. In this setting, if ≤ 3/12 participants have a DLT, participants will be enrolled at the next dose level. If ≥ 4/12 participants have a DLT, further accrual will be permanently halted and the study stopped and 35 Gy will not be recommended as safe. The dosing strategy for the 2nd (45Gy) cohort will be identical to the first.
Overall Study STARTED	3
Overall Study COMPLETED	2
Overall Study NOT COMPLETED	1

Reasons for withdrawal

Reasons for withdrawal
Measure	Treatment (SBRT) Participants undergo Stereotactic Body Radiation Therapy in 5 fractions at least 40 hours apart over 10-18 days. Three dose levels: 40Gy and 45Gy all in 5 fractions. Each initial dose level will have 6 participants allocated to them. All participants are assessed at their 3 month post SBRT visit for Dose-Limiting Toxicities (DLTs). If ≤1 participant experiences a DLT, participants will be enrolled at the next dose level. If ≥3 participants experience a DLT, further accrual will be permanently halted and the study stopped. If 2 participants experience a DLT, then an additional 6 participants will be enrolled at the same dose level. In this setting, if ≤ 3/12 participants have a DLT, participants will be enrolled at the next dose level. If ≥ 4/12 participants have a DLT, further accrual will be permanently halted and the study stopped and 35 Gy will not be recommended as safe. The dosing strategy for the 2nd (45Gy) cohort will be identical to the first.
Overall Study Death	1

Baseline Characteristics

Stereotactic Body Radiation Therapy in Treating Patients With High Risk Locally Advanced Head and Neck Cancer

Baseline characteristics by cohort

Baseline characteristics by cohort
Measure	Treatment (SBRT) n=3 Participants Participants undergo Stereotactic Body Radiation Therapy in 5 fractions at least 40 hours apart over 10-18 days. Three dose levels: 40Gy and 45Gy all in 5 fractions. Each initial dose level will have 6 participants allocated to them. All participants are assessed at their 3 month post SBRT visit for Dose-Limiting Toxicities (DLTs). If ≤1 participant experiences a DLT, participants will be enrolled at the next dose level. If ≥3 participants experience a DLT, further accrual will be permanently halted and the study stopped. If 2 participants experience a DLT, then an additional 6 participants will be enrolled at the same dose level. In this setting, if ≤ 3/12 participants have a DLT, participants will be enrolled at the next dose level. If ≥ 4/12 participants have a DLT, further accrual will be permanently halted and the study stopped and 35 Gy will not be recommended as safe. The dosing strategy for the 2nd (45Gy) cohort will be identical to the first.
Age, Continuous	84 years STANDARD_DEVIATION 14 • n=5 Participants
Sex: Female, Male Female	2 Participants n=5 Participants
Sex: Female, Male Male	1 Participants n=5 Participants
Ethnicity (NIH/OMB) Hispanic or Latino	0 Participants n=5 Participants
Ethnicity (NIH/OMB) Not Hispanic or Latino	3 Participants n=5 Participants
Ethnicity (NIH/OMB) Unknown or Not Reported	0 Participants n=5 Participants
Race (NIH/OMB) American Indian or Alaska Native	0 Participants n=5 Participants
Race (NIH/OMB) Asian	0 Participants n=5 Participants
Race (NIH/OMB) Native Hawaiian or Other Pacific Islander	0 Participants n=5 Participants
Race (NIH/OMB) Black or African American	0 Participants n=5 Participants
Race (NIH/OMB) White	3 Participants n=5 Participants
Race (NIH/OMB) More than one race	0 Participants n=5 Participants
Race (NIH/OMB) Unknown or Not Reported	0 Participants n=5 Participants
Region of Enrollment United States	3 participants n=5 Participants

PRIMARY outcome

Timeframe: 3 months

Population: Patients who received treatment. MTD was not able to be determined because only three patients enrolled and no DLTs were observed. A recommended MTD could only be made if enough patients had accrued to assess toxicities in the different dosage levels.

Maximum tolerated dose of SBRT in this patient population determined by the dose escalation design with doses '40Gy' and '45Gy all in 5 fractions'.

Outcome measures

Outcome data not reported

PRIMARY outcome

Timeframe: 3 months from start of treatment

Population: Participants who enrolled in study and were treated.

Number of patients with dose limiting toxicity events graded according to CTCAE Version 4.0

Outcome measures

Outcome measures
Measure	Treatment (SBRT) n=2 Participants Patients undergo Stereotactic Body Radiation Therapy in 5 fractions at least 40 hours apart over 10-18 days. Three dose levels: 40Gy and 45Gy all in 5 fractions. Each initial dose level will have 6 patients allocated to them. All patients are assessed at their 3 month post SBRT visit for Dose-Limiting Toxicities (DLTs). If ≤1 patient experiences a DLT, patients will be enrolled at the next dose level. If ≥3 patients experience a DLT, further accrual will be permanently halted and the study stopped. If 2 patients experience a DLT, then an additional 6 patients will be enrolled at the same dose level. In this setting, if ≤ 3/12 patients have a DLT, patients will be enrolled at the next dose level. If ≥ 4/12 patients have a DLT, further accrual will be permanently halted and the study stopped and 35 Gy will not be recommended as safe. The dosing strategy for the 2nd (45Gy) cohort will be identical to the first.
Incidence of Dose Limiting Toxicities (DLTs)	0 Participants

SECONDARY outcome

Timeframe: Up to 12 months

Population: Patients who went on study

Kaplan-Meier estimates will be used to plot overall survival - the number of patients alive at 12 months followup

Outcome measures

Outcome measures
Measure	Treatment (SBRT) n=3 Participants Patients undergo Stereotactic Body Radiation Therapy in 5 fractions at least 40 hours apart over 10-18 days. Three dose levels: 40Gy and 45Gy all in 5 fractions. Each initial dose level will have 6 patients allocated to them. All patients are assessed at their 3 month post SBRT visit for Dose-Limiting Toxicities (DLTs). If ≤1 patient experiences a DLT, patients will be enrolled at the next dose level. If ≥3 patients experience a DLT, further accrual will be permanently halted and the study stopped. If 2 patients experience a DLT, then an additional 6 patients will be enrolled at the same dose level. In this setting, if ≤ 3/12 patients have a DLT, patients will be enrolled at the next dose level. If ≥ 4/12 patients have a DLT, further accrual will be permanently halted and the study stopped and 35 Gy will not be recommended as safe. The dosing strategy for the 2nd (45Gy) cohort will be identical to the first.
Overall Survival	0 Participants

SECONDARY outcome

Timeframe: Up to 12 months

Population: No patients were alive at 12 months, so no analysis was done.

Kaplan-Meier estimates will be used to plot local progression free survival.

Outcome measures

Outcome data not reported

SECONDARY outcome

Timeframe: Up to 12 months

Population: There was insufficient patient accrual to perform additional statistical analysis.

Trend tests will be used to investigate the relationship between SBRT dose and response.

Outcome measures

Outcome data not reported

SECONDARY outcome

Timeframe: Up to 12 months

Population: Patients who were eligible for evaluation for SBRT-related morbidity incidence

Number of patients who experiences SBRT-related morbidity according to NCI CTCAE v 4.0

Outcome measures

Outcome measures
Measure	Treatment (SBRT) n=1 Participants Patients undergo Stereotactic Body Radiation Therapy in 5 fractions at least 40 hours apart over 10-18 days. Three dose levels: 40Gy and 45Gy all in 5 fractions. Each initial dose level will have 6 patients allocated to them. All patients are assessed at their 3 month post SBRT visit for Dose-Limiting Toxicities (DLTs). If ≤1 patient experiences a DLT, patients will be enrolled at the next dose level. If ≥3 patients experience a DLT, further accrual will be permanently halted and the study stopped. If 2 patients experience a DLT, then an additional 6 patients will be enrolled at the same dose level. In this setting, if ≤ 3/12 patients have a DLT, patients will be enrolled at the next dose level. If ≥ 4/12 patients have a DLT, further accrual will be permanently halted and the study stopped and 35 Gy will not be recommended as safe. The dosing strategy for the 2nd (45Gy) cohort will be identical to the first.
Incidence of SBRT Related Morbidity	1 Participants

SECONDARY outcome

Timeframe: Up to 12 months

Population: No patient was able to complete 3 month follow up to provide this QOL information

Repeated analysis of variance measures will be used to analyze the quality of life data.

Outcome measures

Outcome data not reported

Adverse Events

Treatment (SBRT)

Serious events: 0 serious events

Other events: 1 other events

Deaths: 3 deaths

Serious adverse events

Adverse event data not reported

Other adverse events

Other adverse events
Measure	Treatment (SBRT) n=3 participants at risk Patients undergo Stereotactic Body Radiation Therapy in 5 fractions at least 40 hours apart over 10-18 days. Stereotactic Body Radiation Therapy: Undergo SBRT Positron Emission Tomography: Undergo PET/CT Computed Tomography: Undergo PET/CT Quality-of-Life Assessment: Ancillary studies
General disorders pain	33.3% 1/3 • Number of events 1 • Adverse events were collected from start of treatment to end of study (over a period of approximately 6 months).
General disorders Fatigue	33.3% 1/3 • Number of events 1 • Adverse events were collected from start of treatment to end of study (over a period of approximately 6 months).

Additional Information

Shlomo Koyfman, MD

Cleveland Clinic, Case Comprehensive Cancer Center

Phone: 216-444-7552

Email: [email protected]

Results disclosure agreements

Principal investigator is a sponsor employee
Publication restrictions are in place