Trial Outcomes & Findings for Nab-paclitaxel and Carboplatin Followed by Response-Based Local Therapy in Treating Patients With Stage III or IV HPV-Related Oropharyngeal Cancer (NCT NCT02258659)

Last Updated: 2024-09-24

Results Overview

If all patients are followed for two years, the PFS rate and confidence interval will be determined based on the exact binomial distribution. Otherwise, PFS will be estimated using the Kaplan-Meier method and a (large-sample) one-sided 90% confidence interval will be derived for the PFS rate at two years to test the non-inferiority hypothesis. Median PFS will be estimated as described in Brookmeyer and Crowley.

Recruitment status

COMPLETED

Study phase

PHASE2

Target enrollment

62 participants

Primary outcome timeframe

Time from enrollment until disease progression or death from any cause, assessed at 2 years

Results posted on

2024-09-24

Participant Flow

Participant milestones

Participant milestones
Measure	Single Arm Radiation therapy alone, combination chemotherapy with low-dose radiation therapy, or combination chemotherapy with high-dose radiation
Overall Study STARTED	62
Overall Study COMPLETED	61
Overall Study NOT COMPLETED	1

Reasons for withdrawal

Reasons for withdrawal
Measure	Single Arm Radiation therapy alone, combination chemotherapy with low-dose radiation therapy, or combination chemotherapy with high-dose radiation
Overall Study Withdrawal by Subject	1

Baseline Characteristics

Nab-paclitaxel and Carboplatin Followed by Response-Based Local Therapy in Treating Patients With Stage III or IV HPV-Related Oropharyngeal Cancer

Baseline characteristics by cohort

Baseline characteristics by cohort
Measure	Single Arm n=62 Participants Radiation therapy alone, combination chemotherapy with low-dose radiation therapy, or combination chemotherapy with high-dose radiation
Age, Continuous	60 years n=5 Participants
Sex: Female, Male Female	3 Participants n=5 Participants
Sex: Female, Male Male	59 Participants n=5 Participants
Race (NIH/OMB) American Indian or Alaska Native	0 Participants n=5 Participants
Race (NIH/OMB) Asian	2 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	4 Participants n=5 Participants
Race (NIH/OMB) White	56 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

PRIMARY outcome

Timeframe: Time from enrollment until disease progression or death from any cause, assessed at 2 years

Outcome measures

Outcome measures
Measure	Single Arm n=62 Participants Radiation therapy alone, combination chemotherapy with low-dose radiation therapy, or combination chemotherapy with high-dose radiation
Progression-Free Survival (PFS), Evaluated Using RECIST Version (v) 1.1	94.5 percentage of participants Interval 88.0 to 96.0

SECONDARY outcome

Timeframe: Up to 8 weeks after completion of CRT

Population: Ten missing values

Pathologic response rates will be determined and 95% confidence intervals obtained using the exact binomial distribution.

Outcome measures

Outcome measures
Measure	Single Arm n=52 Participants Radiation therapy alone, combination chemotherapy with low-dose radiation therapy, or combination chemotherapy with high-dose radiation
Rate of Pathologic Complete Response (PCR) on Post Treatment Biopsy/Surgery, Evaluated Using RECIST v1.1	90 percentage of participants Interval 79.0 to 97.0

SECONDARY outcome

Timeframe: Up to 5 years

Population: one missing value

Clinical response rates will be determined and 95% confidence intervals obtained using the exact binomial distribution.

Outcome measures

Outcome measures
Measure	Single Arm n=61 Participants Radiation therapy alone, combination chemotherapy with low-dose radiation therapy, or combination chemotherapy with high-dose radiation
Clinical Complete Response by Computerized Tomography (CT) & Magnetic Resonance Imaging (MRI) Only complete response	13 percentage of participants Interval 5.8 to 24.0
Clinical Complete Response by Computerized Tomography (CT) & Magnetic Resonance Imaging (MRI) Only Partial Response	80 percentage of participants Interval 68.0 to 89.0
Clinical Complete Response by Computerized Tomography (CT) & Magnetic Resonance Imaging (MRI) Only Stable Disease	13 percentage of participants Interval 5.8 to 24.0

SECONDARY outcome

Timeframe: From the date of registration to the date of death or date of last patient contact if censored, assessed up to 5 years

Overall survival rate

Outcome measures

Outcome measures
Measure	Single Arm n=62 Participants Radiation therapy alone, combination chemotherapy with low-dose radiation therapy, or combination chemotherapy with high-dose radiation
Overall Survival	87 percentage of participants Interval 66.0 to 95.0

SECONDARY outcome

Timeframe: Up to 5 years

Overall Cancer-specific survival rate. Patients dying from non-cancer related causes will be censored at the time of death.

Outcome measures

Outcome measures
Measure	Single Arm n=62 Participants Radiation therapy alone, combination chemotherapy with low-dose radiation therapy, or combination chemotherapy with high-dose radiation
Cancer-specific Survival	95 percentage of participants Interval 85.0 to 98.0

SECONDARY outcome

Timeframe: Up to 5 years

Toxicity rates will be summarized by type of toxicity, grade, and attribution. The incidence of acute (mucositis, xerostomia, anorexia, weight loss, dermatitis and G-tube placement) toxicities will be estimated along with 95% confidence intervals. Toxicity criteria of the Common Toxicity Criteria (CTC) and the Radiation Therapy Oncology Group (RTOG) will be used to determine grades. General CTC grade definitions: 0 = No adverse event or within normal limits; 1 = Mild adverse event; 2 = Moderate adverse event; 3 = Severe and undesirable adverse event; 4 = Life-threatening or disabling adverse event; 5 = Death related to adverse event. For Mucous, 3 = Confluent fibrinous, mucositis / may include severe pain requiring narcotic; 4 = Ulceration, hemorrhage or necrosis. For neutropenia, 3 = Neutrophils 0.5 - \< 1.0; 4 = Neutrophils \< 0.5 or sepsis.

Outcome measures

Outcome measures
Measure	Single Arm n=62 Participants Radiation therapy alone, combination chemotherapy with low-dose radiation therapy, or combination chemotherapy with high-dose radiation
Rates of Acute Toxicity, Determined by Incidence of Mucositis, Xerostomia, Anorexia, Weight Loss, Dermatitis and G-tube Placement Grade 3+ mucositis	35 participants
Rates of Acute Toxicity, Determined by Incidence of Mucositis, Xerostomia, Anorexia, Weight Loss, Dermatitis and G-tube Placement grade 3+ Anorexia	5 participants
Rates of Acute Toxicity, Determined by Incidence of Mucositis, Xerostomia, Anorexia, Weight Loss, Dermatitis and G-tube Placement Grade 3+ dermatitis	12 participants
Rates of Acute Toxicity, Determined by Incidence of Mucositis, Xerostomia, Anorexia, Weight Loss, Dermatitis and G-tube Placement grade 3+ neutropenia	29 participants

SECONDARY outcome

Timeframe: Up to 5 years

Toxicity rates will be summarized by type of toxicity, grade, and attribution. The incidence of late-term (xerostomia, dental decay, osteroradionecrosis, G-tube dependency, speech abnormalities, tracheostomy placement and dysphagia) toxicities will be estimated along with 95% confidence intervals.

Outcome measures

Outcome measures
Measure	Single Arm n=62 Participants Radiation therapy alone, combination chemotherapy with low-dose radiation therapy, or combination chemotherapy with high-dose radiation
Rates of Late Toxicity, Determined by Incidence of Xerostomia, Dental Decay, Osteroradionecrosis, G-tube Dependency, Tracheostomy Placement and Dysphagia G-tube dependence	18 participants
Rates of Late Toxicity, Determined by Incidence of Xerostomia, Dental Decay, Osteroradionecrosis, G-tube Dependency, Tracheostomy Placement and Dysphagia Dysphagia	18 participants

OTHER_PRE_SPECIFIED outcome

Timeframe: Up to 3 months post-treatment

Population: zero analyzed because no data was collected

Results of pathology/histologic review of post induction biopsy specimens will be descriptive and summarize in tabular format.

Outcome measures

Outcome data not reported

OTHER_PRE_SPECIFIED outcome

Timeframe: Up to 3 months post-treatment

Population: zero analyzed because no data was collected

Results of pathology/histologic review of post induction biopsy specimens will be descriptive and summarize in tabular format.

Outcome measures

Outcome data not reported

OTHER_PRE_SPECIFIED outcome

Timeframe: Baseline to up to 2 months after radiation therapy

Population: zero analyzed because no data was collected

Changes in reactive T cells over time will be assessed using mixed effects models and simple paired t-tests.

Outcome measures

Outcome data not reported

Adverse Events

Single Arm

Serious events: 5 serious events

Other events: 60 other events

Deaths: 5 deaths

Serious adverse events

Serious adverse events
Measure	Single Arm n=62 participants at risk Radiation therapy alone, combination chemotherapy with low-dose radiation therapy, or combination chemotherapy with high-dose radiation
Gastrointestinal disorders Abdominal pain	1.6% 1/62 • up to 5 years
Metabolism and nutrition disorders Anorexia	1.6% 1/62 • up to 5 years
Respiratory, thoracic and mediastinal disorders Aspiration	1.6% 1/62 • up to 5 years
Gastrointestinal disorders Constipation	1.6% 1/62 • up to 5 years
Gastrointestinal disorders Diarrhea	1.6% 1/62 • up to 5 years
General disorders Edema limbs	1.6% 1/62 • up to 5 years
General disorders Fatigue	1.6% 1/62 • up to 5 years
General disorders Fever	3.2% 2/62 • up to 5 years
Investigations Neutrophil count decreased	1.6% 1/62 • up to 5 years
Respiratory, thoracic and mediastinal disorders Productive cough	1.6% 1/62 • up to 5 years

Other adverse events

Other adverse events
Measure	Single Arm n=62 participants at risk Radiation therapy alone, combination chemotherapy with low-dose radiation therapy, or combination chemotherapy with high-dose radiation
Renal and urinary disorders Acute kidney injury	6.5% 4/62 • up to 5 years
Gastrointestinal disorders Abdominal pain	17.7% 11/62 • up to 5 years
Investigations Alanine aminotransferase increased	21.0% 13/62 • up to 5 years
Skin and subcutaneous tissue disorders Alopecia	9.7% 6/62 • up to 5 years
Blood and lymphatic system disorders Anemia	38.7% 24/62 • up to 5 years
Metabolism and nutrition disorders Anorexia	77.4% 48/62 • up to 5 years
Psychiatric disorders Anxiety	19.4% 12/62 • up to 5 years
Investigations Aspartate aminotransferase increased	14.5% 9/62 • up to 5 years
Cardiac disorders Atrial fibrillation	6.5% 4/62 • up to 5 years
Eye disorders Blurred vision	6.5% 4/62 • up to 5 years
Musculoskeletal and connective tissue disorders Bone pain	12.9% 8/62 • up to 5 years
Gastrointestinal disorders Constipation	82.3% 51/62 • up to 5 years
Respiratory, thoracic and mediastinal disorders Cough	25.8% 16/62 • up to 5 years
Injury, poisoning and procedural complications Dermatitis radiation	72.6% 45/62 • up to 5 years
Gastrointestinal disorders Diarrhea	48.4% 30/62 • up to 5 years
Nervous system disorders Dizziness	8.1% 5/62 • up to 5 years
Gastrointestinal disorders Dry mouth	71.0% 44/62 • up to 5 years
Nervous system disorders Dysgeusia	83.9% 52/62 • up to 5 years
Gastrointestinal disorders Dysphagia	29.0% 18/62 • up to 5 years
Ear and labyrinth disorders Ear pain	6.5% 4/62 • up to 5 years
General disorders Edema limbs	17.7% 11/62 • up to 5 years
Respiratory, thoracic and mediastinal disorders Epistaxis	24.2% 15/62 • up to 5 years
Gastrointestinal disorders Esophageal pain	16.1% 10/62 • up to 5 years
Eye disorders Eye disorders - Other, specify	6.5% 4/62 • up to 5 years
General disorders Fatigue	96.8% 60/62 • up to 5 years
General disorders Fever	30.6% 19/62 • up to 5 years
Gastrointestinal disorders Gastroesophageal reflux disease	9.7% 6/62 • up to 5 years
Nervous system disorders Headache	14.5% 9/62 • up to 5 years
Respiratory, thoracic and mediastinal disorders Hoarseness	8.1% 5/62 • up to 5 years
Metabolism and nutrition disorders Hypokalemia	6.5% 4/62 • up to 5 years
Injury, poisoning and procedural complications Injury, poisoning and procedural complication	6.5% 4/62 • up to 5 years
Psychiatric disorders Insomnia	16.1% 10/62 • up to 5 years
Vascular disorders Lymphedema	14.5% 9/62 • up to 5 years
Infections and infestations Mucosal infection	9.7% 6/62 • up to 5 years
Gastrointestinal disorders Mucositis oral	90.3% 56/62 • up to 5 years
Musculoskeletal and connective tissue disorders Myalgia	12.9% 8/62 • up to 5 years
Respiratory, thoracic and mediastinal disorders Nasal congestion	14.5% 9/62 • up to 5 years
Gastrointestinal disorders Nausea	90.3% 56/62 • up to 5 years
General disorders Neck edema	6.5% 4/62 • up to 5 years
Investigations Neutrophil count decreased	58.1% 36/62 • up to 5 years
Gastrointestinal disorders Oral pain	33.9% 21/62 • up to 5 years
General disorders Pain	30.6% 19/62 • up to 5 years
Musculoskeletal and connective tissue disorders Pain in extremity	8.1% 5/62 • up to 5 years
Skin and subcutaneous tissue disorders Palmar-plantar erythrodysesthesia syndrome	24.2% 15/62 • up to 5 years
Nervous system disorders Peripheral sensory neuropathy	50.0% 31/62 • up to 5 years
Respiratory, thoracic and mediastinal disorders Pharyngolaryngeal pain	21.0% 13/62 • up to 5 years
Investigations Platelet count decreased	58.1% 36/62 • up to 5 years
Respiratory, thoracic and mediastinal disorders Postnasal drip	6.5% 4/62 • up to 5 years
Skin and subcutaneous tissue disorders Pruritus	27.4% 17/62 • up to 5 years
Skin and subcutaneous tissue disorders Skin and subcutaneous tissue disorder	8.1% 5/62 • up to 5 years
Skin and subcutaneous tissue disorders Skin ulceration	11.3% 7/62 • up to 5 years
Respiratory, thoracic and mediastinal disorders Sore throat	9.7% 6/62 • up to 5 years
Vascular disorders Thromboembolic event	9.7% 6/62 • up to 5 years
Gastrointestinal disorders Vomiting	38.7% 24/62 • up to 5 years
Investigations Weight loss	40.3% 25/62 • up to 5 years
Investigations White blood cell decreased	22.6% 14/62 • up to 5 years

Additional Information

Dr. Everett Vokes

University of Chicago

Phone: 773-702-9306

Email: [email protected]

Results disclosure agreements

Principal investigator is a sponsor employee
Publication restrictions are in place