Trial Outcomes & Findings for Paclitaxel, Carboplatin and Radiotherapy as Induction Therapy in Locally Advanced Head and Neck Cancer (NCT NCT00176254)

Last Updated: 2023-05-16

Results Overview

Per Response Evaluation Criteria In Solid Tumors Criteria (RECIST v1.0) for target lesions and assessed by MRI: Complete Response (CR), Disappearance of all target lesions; Partial Response (PR), \>=30% decrease in the sum of the longest diameter of target lesions; Overall Response (OR) = CR + PR

Recruitment status

COMPLETED

Study phase

PHASE2

Target enrollment

40 participants

Primary outcome timeframe

assessed pre-study and once between days 36-57

Results posted on

2023-05-16

Participant Flow

Dates of Recruitment: July 2000-May 2002. All patients were recruited from University of Kentucky Markey Cancer Center

Participant milestones

Participant milestones
Measure	Treatment Arm: Induction LDFRT and Chemotherapy Carboplatin : AUC of 6 will be given intravenously over 30 minutes on days 1 and 22 Paclitaxel : 225 mg/m\^2 intravenously over three hours on Days 1 and 22 Radiotherapy : 80 cGy on Day 1 \& 2 and 22 \& 23 of chemotherapy
Overall Study STARTED	40
Overall Study COMPLETED	39
Overall Study NOT COMPLETED	1

Reasons for withdrawal

Reasons for withdrawal
Measure	Treatment Arm: Induction LDFRT and Chemotherapy Carboplatin : AUC of 6 will be given intravenously over 30 minutes on days 1 and 22 Paclitaxel : 225 mg/m\^2 intravenously over three hours on Days 1 and 22 Radiotherapy : 80 cGy on Day 1 \& 2 and 22 \& 23 of chemotherapy
Overall Study Lost to Follow-up	1

Baseline Characteristics

Paclitaxel, Carboplatin and Radiotherapy as Induction Therapy in Locally Advanced Head and Neck Cancer

Baseline characteristics by cohort

Baseline characteristics by cohort
Measure	Treatment Arm: Induction LDFRT and Chemotherapy n=40 Participants Carboplatin : AUC of 6 will be given intravenously over 30 minutes on days 1 and 22 Paclitaxel : 225 mg/m2 intravenously over three hours on Days 1 and 22 Radiotherapy : 80 cGy on Day 1 \& 2 and 22 \& 23 of chemotherapy
Age, Continuous	54 Years n=5 Participants
Sex: Female, Male Female	8 Participants n=5 Participants
Sex: Female, Male Male	32 Participants n=5 Participants
Region of Enrollment United States	40 participants n=5 Participants

PRIMARY outcome

Timeframe: assessed pre-study and once between days 36-57

Outcome measures

Outcome measures
Measure	Treatment Arm: Induction LDFRT and Chemotherapy n=39 Participants Carboplatin : AUC of 6 will be given intravenously over 30 minutes on days 1 and 22 Paclitaxel : 225 mg/m2 intravenously over three hours on Days 1 and 22 Radiotherapy : 80 cGy on Day 1 \& 2 and 22 \& 23 of chemotherapy
Response Rate to Induction Chemotherapy Prior to Definitive Therapy (Surgery or Radiation)	32 participants Interval 0.66 to 0.92

SECONDARY outcome

Timeframe: assessed starting on day 1 through study day 58 or until toxicity resolves

Population: Intent to Treat

Outcome measures

Outcome measures
Measure	Treatment Arm: Induction LDFRT and Chemotherapy n=40 Participants Carboplatin : AUC of 6 will be given intravenously over 30 minutes on days 1 and 22 Paclitaxel : 225 mg/m2 intravenously over three hours on Days 1 and 22 Radiotherapy : 80 cGy on Day 1 \& 2 and 22 \& 23 of chemotherapy
Frequency of Severe (>/= Grade 3) Toxicities	36 adverse events

SECONDARY outcome

Timeframe: 5 years post study

Outcome measures

Outcome measures
Measure	Treatment Arm: Induction LDFRT and Chemotherapy n=39 Participants Carboplatin : AUC of 6 will be given intravenously over 30 minutes on days 1 and 22 Paclitaxel : 225 mg/m2 intravenously over three hours on Days 1 and 22 Radiotherapy : 80 cGy on Day 1 \& 2 and 22 \& 23 of chemotherapy
5 Year Overall Survival Rates	24 participants 0.0779

SECONDARY outcome

Timeframe: 5 years

Outcome is calculated from the time of enrollment to the time of death due to disease under study or survival to 5 years without death from disease under study, whichever occurs first.The 5-year rates of disease-specific survival were calculated using the Kaplan-Meier method.

Outcome measures

Outcome measures
Measure	Treatment Arm: Induction LDFRT and Chemotherapy n=39 Participants Carboplatin : AUC of 6 will be given intravenously over 30 minutes on days 1 and 22 Paclitaxel : 225 mg/m2 intravenously over three hours on Days 1 and 22 Radiotherapy : 80 cGy on Day 1 \& 2 and 22 \& 23 of chemotherapy
5 Year Disease-specific Survival	26 participants

SECONDARY outcome

Timeframe: 5 years

Progression is defined using Response Evaluation Criteria In Solid Tumors Criteria (RECIST v1.0), as a 20% increase in the sum of the longest diameter of target lesions, or a measurable increase in a non-target lesion, or the appearance of new lesions

Outcome measures

Outcome measures
Measure	Treatment Arm: Induction LDFRT and Chemotherapy n=39 Participants Carboplatin : AUC of 6 will be given intravenously over 30 minutes on days 1 and 22 Paclitaxel : 225 mg/m2 intravenously over three hours on Days 1 and 22 Radiotherapy : 80 cGy on Day 1 \& 2 and 22 \& 23 of chemotherapy
5 Year Progression Free Survival	23 participants

Adverse Events

Treatment Arm: Induction LDFRT and Chemotherapy

Serious events: 16 serious events

Other events: 35 other events

Deaths: 0 deaths

Serious adverse events

Serious adverse events
Measure	Treatment Arm: Induction LDFRT and Chemotherapy n=40 participants at risk Carboplatin : AUC of 6 will be given intravenously over 30 minutes on days 1 and 22 Paclitaxel : 225 mg/m2 intravenously over three hours on Days 1 and 22 Radiotherapy : 80 cGy on Day 1 \& 2 and 22 \& 23 of chemotherapy
Infections and infestations Neutropenia	37.5% 15/40
Infections and infestations Infection/Fever	2.5% 1/40

Other adverse events

Other adverse events
Measure	Treatment Arm: Induction LDFRT and Chemotherapy n=40 participants at risk Carboplatin : AUC of 6 will be given intravenously over 30 minutes on days 1 and 22 Paclitaxel : 225 mg/m2 intravenously over three hours on Days 1 and 22 Radiotherapy : 80 cGy on Day 1 \& 2 and 22 \& 23 of chemotherapy
Infections and infestations Neutropenia	25.0% 10/40
General disorders Anemia	30.0% 12/40
Blood and lymphatic system disorders Thrombocytopenia	7.5% 3/40
Infections and infestations Infection/Fever	30.0% 12/40
General disorders Arthralgias/myalgias	52.5% 21/40
General disorders Nausea	42.5% 17/40
General disorders Alopecia	70.0% 28/40
Gastrointestinal disorders GI	10.0% 4/40
General disorders Mucositis	12.5% 5/40
Nervous system disorders Neuromotor	7.5% 3/40
General disorders Fatigue	10.0% 4/40
General disorders Dysuria	10.0% 4/40
Skin and subcutaneous tissue disorders Dermatologic	7.5% 3/40
General disorders Pulmonary	5.0% 2/40
General disorders Weight Loss	5.0% 2/40

Additional Information

Dr. Emily Van Meter/Assistant Professor, Division of Cancer Biostatistics

University of Kentucky

Phone: 859-323-3076

Email: [email protected]

Results disclosure agreements

Principal investigator is a sponsor employee
Publication restrictions are in place