Trial Outcomes & Findings for The Quarterback Trial: Reduced Dose Radiotherapy for HPV+ Oropharynx Cancer (NCT NCT01706939)

23 participants were assessed and started in pre-randomization induction phase. Participants were not randomized until after they completed the pre-randomization phase and TPF induction.

The Quarterback Trial: Reduced Dose Radiotherapy for HPV+ Oropharynx Cancer

Progression free survival (PFS) at 5 years in patients with advanced HPV related oropharynx cancer, nasopharynx cancer or unknown primary treated with reduced or standard dose radiation.

Local-regional control (LRC) at 3 years in patients with advanced HPV related oropharynx cancer or unknown primary treated with reduced or standard dose radiation.

Overall Survival (OS) 5 years treated with reduced or standard dose CRT.

Number of participants with acute toxicity treated with reduced or standard dose CRT.

To determine biomarkers predictive of failure with either reduced or standard dose radiotherapy.

MDADI is a questionnaire of 20 questions and contains a global subscale, and three other categories of questions (emotional, functional, and physical). The scores are summed and a mean score is calculated. This mean score was multiplied by 20 to obtain a score, with a range of 0 (extremely low functioning) to 100 (high functioning). Thus, a higher MDADI score represented better day-to-day functioning and better QOL.

MD Anderson Symptom Inventory Symptom Inventory and Severity (MDASI-HN SI and SS) MDASI Head and Neck is a site-specific MDASI module which includes the core MDASI 13 symptom severity items (SS) and 6 symptom interference items (SI), alongside 9 items relevant to head and neck cancer. The scores are summed and a mean score is calculated on a scale of 0 (low severity or interference) to 10 (high severity or complete interference). In order to calculate the mean score, a majority of the subscale's items must have been completed. A lower or negative score reflects a better quality of life compared to baseline.

XQ is a nine questions survey developed specifically for xerostomia symptoms. The scores are summed and a mean score is calculated on a scale of 0 (low xerostomia interference) to 10 (high xerostomia interference). A lower or negative score reflects a better quality of life compared to baseline.

The EORTC Head and Neck module was specifically designed and validated for head and neck cancer patients. This 35-item questionnaire contains 7 symptom scales (pain, swallowing, senses, speech, social eating, social contact, and sexuality), 6 single-item scales (difficulties of teeth, mouth opening, dry mouth, sticky saliva, coughing, and feeling ill), and 5 items about the additional use of pain medicine, nutritional supplements, and feeding tube and changes in body weight. All items were transformed to scales from 0 to 100, and divided into respective sub-scores of global health (GHS), functional (FS), and symptom scale (SS). Subscales from 0-100. A high score on global health and functional scale represents a better level of functioning, whereas a high score on a symptom scale and head and neck module indicates more severe symptoms.