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Carboplatin

Patients randomized to receive a reduced (5600 cGy) dose radiotherapy with weekly Carboplatin

Patients randomized to receive a standard (7000 cGy) dose radiotherapy with carboplatin

Reduced Dose Radiation (5600 cGy) dose radiotherapy

Reduced Dose Radiation

Standard Dose Radiation (7000 cGy) dose radiotherapy

Standard Dose Radiation

Marshall Posner, M.D.

This trial aims to directly compare a reduced radiation dose to the standard of care in HPVOPC for non-inferiority, thus allowing for direct comparison of outcomes between the two groups. The study hypothesis is that LRC and PFS at 3 years for reduced dose CRT are non-inferior to standard dose CRT.

This is a randomized Phase III study comparing two doses of definitive radiation therapy given with induction and concurrent chemotherapy in HPV-positive oropharynx, unknown primary or nasopharynx cancer. Eligible, consented and registered patients will receive three cycles of Docetaxel Cisplatin and 5-FU (TPF) induction chemotherapy. After 3 cycles, the patients will be assessed for clinical, radiographic and pathologic response to TPF. Patients with a clinical or radiographic CR or PR will be randomized on the second phase of this study, where patients will undergo a 2:1 randomization to reduced (5600 cGy) or standard (7000 cGy) dose radiotherapy with weekly Carboplatin. Patients not meeting the response criteria will be treated with standard dose CRT. Patients not completing 3 cycles TPF for reasons of toxicity, progressive disease, choice, or other medical necessity will be treated with standard dose CRT or surgery depending on their primary site and overall medical condition and followed for survival. Toxicity will be assessed by Symptom scores, QOL and SAE monitoring. The primary end point of the trial is equivalent local regional control and PFS at 3 years. Patients will be followed for 5 years.

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

The Quarterback Trial: A Randomized Phase III Clinical Trial Comparing Reduced and Standard Radiation Therapy Doses for Locally Advanced HPV Positive Oropharynx Cancer

randomized trial should not be shared until trial is over.

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.

The Biodesign Institute

Arizona State University

Icahn School of Medicine at Mount Sinai

Director, Head and Neck Medical Oncology

Adverse Events were not collected for the pre-randomization phase. Adverse events assessed for participants who were randomized.

Participants received three cycles of Docetaxel, Cisplatin and 5-RU (TPF)

Pre-Randomization

After TPF induction chemotherapy patients randomized to receive a reduced (5600 cGy) dose radiotherapy with weekly Carboplatin

Reduced Dose Radiation: Reduced Dose Radiation (5600 cGy) dose radiotherapy

Carboplatin: Day 1, every 7 days ( + 2 days)

After TPF induction chemotherapy patients randomized to receive a standard (7000 cGy) dose radiotherapy with carboplatin

Standard Dose Radiation: Standard Dose Radiation (7000 cGy) dose radiotherapy

Carboplatin: Day 1, every 7 days ( + 2 days)

Total

Age, Continuous

Sex: Female, Male

Ethnicity (NIH/OMB)

Race (NIH/OMB)

Base of Tongue (BOT)

Tonsil

Tumor Site

HPV 16

Other than HPV 16

HPV Status

Never smoker

<10 pack-years

10-20 pack-years

Smoking Status

Dr. Marshall R Posner

at 3 years

at 5 years

Number of Participants With Progression Free Survival (PFS)

Number of Participants With Local-regional Control

Number of Participants With Overall Survival at 5 Years

Number of Participants With Acute Toxicity of Chemoradiotherapy (CRT)

Biomarkers Predictive of Failure

Overall Survival at 15 Years

Of the 20 participants, 3 had progression of disease, and 2 were excluded due to insufficient survey compliance.

Study title	NCT ID	Conditions	Interventions	Eligibility	Organization
The Quarterback Trial: Reduced Dose Radiotherapy for HPV+ Oropharynx Cancer	NCT01706939	Squamous Cell C...	Reduced Dose Ra... Standard Dose R... Carboplatin	18 Years -	Icahn School of Medicine at Mount Sinai
The Quarterback Trial: Reduced Dose Radiotherapy for HPV+ Oropharynx Cancer	NCT01706939	Squamous Cell C...	Reduced Dose Ra... Standard Dose R... Carboplatin	18 Years -	Icahn School of Medicine at Mount Sinai
The Quarterback Trial: Reduced Dose Radiotherapy for HPV+ Oropharynx Cancer	NCT01706939	Squamous Cell C...	Reduced Dose Ra... Standard Dose R... Carboplatin	18 Years -	Icahn School of Medicine at Mount Sinai

Spots Global Cancer Trial Database for reduced dose radiation