Trial · NCT02258659

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

NCT02258659, Phase 2, Completed, University of Chicago; results first posted 2021-01-08

3 sourcestrials-2026-11-12-0.5.0

Cite this record

ConductScience Library. Nab-paclitaxel and Carboplatin Followed by Response-Based Local Therapy in Treating Patients With Stage III or IV HPV-Related Oropharyngeal Cancer. Trials, record NCT02258659. Release trials-2026-11-12-0.5.0, 12 Nov 2026. https://conductscience.org/library/trials/NCT02258659

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Trial

As registered on ClinicalTrials.gov, in the graph's capture of the registry.

Title: Nab-paclitaxel and Carboplatin Followed by Response-Based Local Therapy in Treating Patients With Stage III or IV HPV-Related Oropharyngeal Cancer
NCT number: NCT02258659
Status: Completed
Phases: Phase 2
Enrollment: 62 participants, actual
Lead sponsor: University of Chicago
Conditions: Human Papilloma Virus Infection, Stage III Squamous Cell Carcinoma of the Oropharynx, Stage IVA Squamous Cell Carcinoma of the Oropharynx, Stage IVB Squamous Cell Carcinoma of the Oropharynx
Interventions: paclitaxel albumin-stabilized nanoparticle formulation, carboplatin, radiation therapy, paclitaxel, fluorouracil, hydroxyurea, cisplatin, laboratory biomarker analysis, quality-of-life assessment
First posted: 2014-10-07
Last updated: 2024-09-24
Results first posted: 2021-01-08

Source ClinicalTrials.gov

Registered outcomes10

Each outcome the trial registered, primary first, in ClinicalTrials.gov's words.

List	Outcome	Time frame	Description
Primary	Progression-Free Survival (PFS), Evaluated Using RECIST Version (v) 1.1	Time from enrollment until disease progression or death from any cause, assessed at 2 years	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.
Secondary	Rate of Pathologic Complete Response (PCR) on Post Treatment Biopsy/Surgery, Evaluated Using RECIST v1.1	Up to 8 weeks after completion of CRT	Pathologic response rates will be determined and 95% confidence intervals obtained using the exact binomial distribution.
Secondary	Clinical Complete Response by Computerized Tomography (CT) & Magnetic Resonance Imaging (MRI) Only	Up to 5 years	Clinical response rates will be determined and 95% confidence intervals obtained using the exact binomial distribution.
Secondary	Overall Survival	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
Secondary	Cancer-specific Survival	Up to 5 years	Overall Cancer-specific survival rate. Patients dying from non-cancer related causes will be censored at the time of death.
Secondary	Rates of Acute Toxicity, Determined by Incidence of Mucositis, Xerostomia, Anorexia, Weight Loss, Dermatitis and G-tube Placement	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.
Secondary	Rates of Late Toxicity, Determined by Incidence of Xerostomia, Dental Decay, Osteroradionecrosis, G-tube Dependency, Tracheostomy Placement and Dysphagia	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.
Other	Histologic Appearance of Post-induction Tumor Tissue	Up to 3 months post-treatment	Results of pathology/histologic review of post induction biopsy specimens will be descriptive and summarize in tabular format.
Other	Histologic Appearance of Post-CRT Tumor Tissue	Up to 3 months post-treatment	Results of pathology/histologic review of post induction biopsy specimens will be descriptive and summarize in tabular format.
Other	Changes in Reactive T Cells	Baseline to up to 2 months after radiation therapy	Changes in reactive T cells over time will be assessed using mixed effects models and simple paired t-tests.

Source ClinicalTrials.gov

Outcomes10

Each outcome the trial posted results for, in ClinicalTrials.gov's words.

Type	Outcome	Time frame	Population	Units	Measured as
PRIMARY	Progression-Free Survival (PFS), Evaluated Using RECIST Version (v) 1.1	Time from enrollment until disease progression or death from any cause, assessed at 2 years		percentage of participants	NUMBER
SECONDARY	Rate of Pathologic Complete Response (PCR) on Post Treatment Biopsy/Surgery, Evaluated Using RECIST v1.1	Up to 8 weeks after completion of CRT	Ten missing values	percentage of participants	NUMBER
SECONDARY	Clinical Complete Response by Computerized Tomography (CT) & Magnetic Resonance Imaging (MRI) Only	Up to 5 years	one missing value	percentage of participants	NUMBER
SECONDARY	Overall Survival	From the date of registration to the date of death or date of last patient contact if censored, assessed up to 5 years		percentage of participants	NUMBER
SECONDARY	Cancer-specific Survival	Up to 5 years		percentage of participants	NUMBER
SECONDARY	Rates of Acute Toxicity, Determined by Incidence of Mucositis, Xerostomia, Anorexia, Weight Loss, Dermatitis and G-tube Placement	Up to 5 years		participants	NUMBER
SECONDARY	Rates of Late Toxicity, Determined by Incidence of Xerostomia, Dental Decay, Osteroradionecrosis, G-tube Dependency, Tracheostomy Placement and Dysphagia	Up to 5 years		participants	NUMBER
OTHER_PRE_SPECIFIED	Histologic Appearance of Post-induction Tumor Tissue	Up to 3 months post-treatment	zero analyzed because no data was collected
OTHER_PRE_SPECIFIED	Histologic Appearance of Post-CRT Tumor Tissue	Up to 3 months post-treatment	zero analyzed because no data was collected
OTHER_PRE_SPECIFIED	Changes in Reactive T Cells	Baseline to up to 2 months after radiation therapy	zero analyzed because no data was collected

Source ClinicalTrials.gov

Results by group13

Each measurement the trial posted, group by group, in the words and numbers it posted.

Outcome	Group	Category	Value	Spread	Units
Progression-Free Survival (PFS), Evaluated Using RECIST Version (v) 1.1	Single Arm		94.5	90% Confidence Interval 88 to 96	percentage of participants
Rate of Pathologic Complete Response (PCR) on Post Treatment Biopsy/Surgery, Evaluated Using RECIST v1.1	Single Arm		90	95% Confidence Interval 79 to 97	percentage of participants
Clinical Complete Response by Computerized Tomography (CT) & Magnetic Resonance Imaging (MRI) Only	Single Arm	complete response	13	95% Confidence Interval 5.8 to 24	percentage of participants
Clinical Complete Response by Computerized Tomography (CT) & Magnetic Resonance Imaging (MRI) Only	Single Arm	Partial Response	80	95% Confidence Interval 68 to 89	percentage of participants
Clinical Complete Response by Computerized Tomography (CT) & Magnetic Resonance Imaging (MRI) Only	Single Arm	Stable Disease	13	95% Confidence Interval 5.8 to 24	percentage of participants
Overall Survival	Single Arm		87	95% Confidence Interval 66 to 95	percentage of participants
Cancer-specific Survival	Single Arm		95	95% Confidence Interval 85 to 98	percentage of participants
Rates of Acute Toxicity, Determined by Incidence of Mucositis, Xerostomia, Anorexia, Weight Loss, Dermatitis and G-tube Placement	Single Arm	Grade 3+ mucositis	35		participants
Rates of Acute Toxicity, Determined by Incidence of Mucositis, Xerostomia, Anorexia, Weight Loss, Dermatitis and G-tube Placement	Single Arm	Grade 3+ dermatitis	12		participants
Rates of Acute Toxicity, Determined by Incidence of Mucositis, Xerostomia, Anorexia, Weight Loss, Dermatitis and G-tube Placement	Single Arm	grade 3+ neutropenia	29		participants

1 to 10 of 13Source ClinicalTrials.gov

See all 13 results by group

Participant flow3

How many started, completed or left each group, period by period.

Period	Milestone	Group	Participants
Overall Study	STARTED	Single Arm	62
Overall Study	COMPLETED	Single Arm	61
Overall Study	NOT COMPLETED	Single Arm	1

Source ClinicalTrials.gov

Adverse events66

Each adverse event the trial posted, group by group: the participants affected out of those at risk.

Type	Event	Organ system	Group	Affected	At risk
other	Acute kidney injury	Renal and urinary disorders	Single Arm	4	62
other	Abdominal pain	Gastrointestinal disorders	Single Arm	11	62
other	Alanine aminotransferase increased	Investigations	Single Arm	13	62
other	Alopecia	Skin and subcutaneous tissue disorders	Single Arm	6	62
other	Anemia	Blood and lymphatic system disorders	Single Arm	24	62
other	Anorexia	Metabolism and nutrition disorders	Single Arm	48	62
other	Anxiety	Psychiatric disorders	Single Arm	12	62
other	Aspartate aminotransferase increased	Investigations	Single Arm	9	62
other	Atrial fibrillation	Cardiac disorders	Single Arm	4	62
other	Blurred vision	Eye disorders	Single Arm	4	62

1 to 10 of 66Source ClinicalTrials.gov

See all 66 adverse events

Adverse event totals3

The totals the trial posted for each group.

Total	Group	Affected	At risk
Total, all-cause mortality	Single Arm	5	62
Total, other adverse events	Single Arm	60	62
Total, serious adverse events	Single Arm	5	62

Source ClinicalTrials.gov

Papers1

The papers the trial lists on ClinicalTrials.gov.

PMID	Listed as
30481287	DERIVED

Source PubMed

Grants1

The grants NIH RePORTER links to the trial, newest funded first: NIH's, and some of AHRQ's, CDC's, FDA's and VA's. Each shows its title, principal investigators, organization and funder in its newest year.

Project	Title	Principal investigators	Organization	Funder	Fiscal years
P30CA014599	Cancer Center Support Grant	ODUNSI, KUNLE	UNIVERSITY OF CHICAGO	NATIONAL CANCER INSTITUTE	1985 to 2025

Source NIH RePORTER

Trial comparisons0

Comparisons of the trial's two groups, calculated by ConductScience from the counts it posted.

None in this release.

Tests0

The ConductCognition tests this trial's registered outcomes name, as ScienceGraph matched them in trial-tests-2026-11-12-0.2.1.

None in this release.

Data dates

The day each source was copied for this release.

ClinicalTrials.gov: 2026-11-12; ClinicalTrials.gov
Results, from AACT: 2026-03-23; AACT
NIH grant links: 2026-11-13; NIH RePORTER

Sources 3

ClinicalTrials.gov's posted results, through CTTI's AACTFreely available. Acknowledgement requested
ClinicalTrials.govNo license stated
NIH RePORTER's clinical studies and project filesPublic domain

Each source's terms

ClinicalTrials.gov's posted results, through CTTI's AACTClinicalTrials.gov data via Aggregate Analysis of ClinicalTrials.gov (AACT), CTTI. CTTI makes its materials freely available and requests acknowledgement. https://aact.ctti-clinicaltrials.org/documentation/299
ClinicalTrials.govnone stated
NIH RePORTER's clinical studies and project filesPublic domain (NIH RePORTER)

ClinicalTrials.gov's data carry an international copyright outside the United States: https://clinicaltrials.gov/about-site/terms-conditions.

For software

Read this trial from software.

The record and each of its lists are JSON, twenty rows a page. No key.

GET https://conductscience.org/api/trials/v1/NCT02258659

GET https://conductscience.org/api/trials/v1/NCT02258659/events?page=2

API reference For AI assistants