Patients undergo radiation therapy once daily for weeks.

Patients receive hydroxyurea PO BID on days 0-5, fluorouracil IV continuously on days 1-5, and paclitaxel IV over 60 minutes on day 1. Patients also receive low-dose radiation therapy BID on days 1-5. Treatment repeats every 14 days for 3 courses in the absence of disease progression or unacceptable toxicity.

Patients receive hydroxyurea PO BID on days 0-5, fluorouracil IV continuously on days 1-5, and paclitaxel IV over 60 minutes on day 1. Patients also receive standard-dose radiation therapy BID on days 1-5. Treatment repeats every 14 days for up to 5 courses in the absence of disease progression or unacceptable toxicity.*
*NOTE: At the discretion of the PI, patients may receive cisplatin IV over 1-3 hours every 3 weeks during radiation therapy instead of paclitaxel and undergo daily radiation therapy.

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

paclitaxel albumin-stabilized nanoparticle formulation

carboplatin

radiation therapy

paclitaxel

fluorouracil

hydroxyurea

cisplatin

laboratory biomarker analysis

quality-of-life assessment

University of Chicago

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

An Exploratory Pilot Study of Nab-paclitaxel Based Induction Chemotherapy Followed by Response-Stratified Locoregional Therapy for Patients With Stage III and IV HPV-Related Oropharyngeal Cancer - the OPTIMA HPV Trial

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.

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

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

Kaplan-Meier curves will be generated. In addition, cumulative incidence curves will be derived for the competing risks of cancer and non-cancer death.

Kaplan-Meier curves will be generated. Patients dying from non-cancer related causes will be censored at the time of death. In addition, cumulative incidence curves will be derived for the competing risks of cancer and non-cancer death.

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 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.

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

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

oropharyngeal neoplasms/альбуміны

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

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