Trial Outcomes & Findings for Induction Chemo Then Concurrent Chemoradiotherapy With Cetuximab in Locally Advanced Head and Neck Squamous Cell Cancer (NCT NCT01326923)

Results Overview

Disappearance of all target lesions. Any pathological lymph nodes (whether target or non-target) must have reduction in short axis to \<10 mm.

Recruitment status

TERMINATED

Study phase

PHASE2

Target enrollment

7 participants

Primary outcome timeframe

Analysis at Week 26

Results posted on

2020-10-09

Participant Flow

Participant milestones

Participant milestones
Measure	Single Arm Single arm Phase II Study Induction Chemo then Concurrent Chemoradiotherapy with Cetuximab in Locally Advanced Head and Neck Squamous Cell Cancer Cetuximab: Single arm phase II study of chemotherapy
Overall Study STARTED	7
Overall Study COMPLETED	7
Overall Study NOT COMPLETED	0

Reasons for withdrawal

Withdrawal data not reported

Baseline Characteristics

Race and Ethnicity were not collected from any participant.

Baseline characteristics by cohort

Baseline characteristics by cohort
Measure	Single Arm n=7 Participants Single arm Phase II Study Induction Chemo then Concurrent Chemoradiotherapy with Cetuximab in Locally Advanced Head and Neck Squamous Cell Cancer Cetuximab: Single arm phase II study of chemotherapy
Age, Categorical <=18 years	0 Participants n=7 Participants
Age, Categorical Between 18 and 65 years	7 Participants n=7 Participants
Age, Categorical >=65 years	0 Participants n=7 Participants
Age, Continuous	48 years n=7 Participants
Sex: Female, Male Female	2 Participants n=7 Participants
Sex: Female, Male Male	5 Participants n=7 Participants
Region of Enrollment United States	7 Participants n=7 Participants

PRIMARY outcome

Timeframe: Analysis at Week 26

Population: The Principal Investigator left the institution. Despite exhausting all efforts to contact the Responsible Party and study team members to retrieve the collected data, or to have them enter the data, efforts were unsuccessful, and no data are available to be reported

Disappearance of all target lesions. Any pathological lymph nodes (whether target or non-target) must have reduction in short axis to \<10 mm.

Outcome measures

Outcome data not reported

SECONDARY outcome

Timeframe: Analysis at Week 26

Population: The Principal Investigator left the institution. Despite exhausting all efforts to contact the Responsible Party and study team members to retrieve the collected data, or to have them enter the data, efforts were unsuccessful, and no data are available to be reported

Improvement in progression free survival (PFS)in locally advanced stage III and IV head and neck cancer patients with sequential (ICT) followed by Concurrent chemo-radiotherapy (CR) using monoclonal antibody Cetuximab as compared to historical controls.

Outcome measures

Outcome data not reported

Adverse Events

Single Arm

Serious events: 2 serious events

Other events: 0 other events

Deaths: 0 deaths

Serious adverse events

Serious adverse events
Measure	Single Arm n=7 participants at risk Single arm Phase II Study Induction Chemo then Concurrent Chemoradiotherapy with Cetuximab in Locally Advanced Head and Neck Squamous Cell Cancer Cetuximab: Single arm phase II study of chemotherapy
Infections and infestations shingles	14.3% 1/7 • Number of events 1
Gastrointestinal disorders hospitalizations	14.3% 1/7 • Number of events 2

Other adverse events

Adverse event data not reported

Additional Information

J.K. Miller

LSU Health Shreveport

Phone: 318 8131406

Email: [email protected]

Results disclosure agreements

Principal investigator is a sponsor employee
Publication restrictions are in place