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

NCT01706939 | Active Not Recruiting Phase 3 Results DMC FDA Drug

• 1 other identifier: GCO 12-1050
• Study Type: interventional
• Target: 23
• Locations: 1 country
• Sites: 1

Brief Summary

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.

Conditions

Squamous Cell Carcinomas

Keywords

Reduced radiotherapy; Randomization, Phase III; Reduced radiation therapy; head and neck; oropharynx; unknown primary (cervical lymph nodes); nasopharynx primary; HPV; p16

Outcome Measures

Primary Outcomes (1)

• Number of Participants With Progression Free Survival (PFS)

  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.

  at 3 and 5 years

Secondary Outcomes (9)

• Number of Participants With Local-regional Control

  at 3 years

• Number of Participants With Overall Survival at 5 Years

  at 5 years

• Number of Participants With Acute Toxicity of Chemoradiotherapy (CRT)

  at 5 years

• Biomarkers Predictive of Failure

  at 5 years

• Overall Survival at 15 Years

  at 15 years

Study Arms (2)

Reduced Dose Radiation

EXPERIMENTAL

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

Radiation: Reduced Dose Radiation; Drug: Carboplatin

Standard Dose Radiation

ACTIVE COMPARATOR

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

Radiation: Standard Dose Radiation; Drug: Carboplatin

Interventions

Reduced Dose Radiation RADIATION

Reduced Dose Radiation (5600 cGy) dose radiotherapy

Reduced Dose Radiation

Standard Dose Radiation RADIATION

Standard Dose Radiation (7000 cGy) dose radiotherapy

Standard Dose Radiation

Carboplatin DRUG

Day 1, every 7 days ( + 2 days)

Reduced Dose Radiation; Standard Dose Radiation

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Participants must have histologically or cytologically confirmed squamous cell carcinoma of the oropharynx, unknown primary, or nasopharynx that is HPV positive as determined by PCR and p16 positive as determined by IHC. Tissue from the primary site must be available for biomarker studies. PCR and IHC must be performed in the central laboratory (Zhang, MSSM)
• Stage 3 or 4 disease without evidence of distant metastases.
• At least one clinically evaluable or uni- or bi-dimensionally measurable lesion by RECIST 1.1 criteria.
• Age \> 18 years.
• No previous surgery, radiation therapy or chemotherapy for SSCHN (other than biopsy or tonsillectomy) is allowed at time of study entry.
• ECOG performance status of 0 or 1.
• No active alcohol addiction (as assessed by medical caregiver and defined as at least 6 months without activity).
• Participants must have adequate bone marrow, hepatic and renal functions as defined in the protocol.
• Ability to understand and the willingness to sign a written informed consent document.
• Patients with Gilbert's Disease and absent hepatic pathology by history and clinical assessment maybe treated on study with bilirubins \> the ULN for the institution if other liver function studies are within the normal range

You may not qualify if:

• Pregnant or breast feeding women, or women and men of childbearing potential not willing to use adequate contraception while on treatment and for at least 3 months thereafter.
• Previous or current malignancies at other sites, with the exception of adequately treated in situ carcinoma of the cervix, basal or squamous cell carcinoma of the skin, thyroid cancer, or other cancer curatively treated by surgery and with no current evidence of disease for at least 5 years.
• Symptomatic peripheral neuropathy ≥ grade 2 by NCI Common Terminology Criteria (NCI-CTC) version 4.
• Symptomatic altered hearing \> grade 2 by NCI-CTCv4 criteria.
• Other serious illnesses or medical conditions including but not limited to:
• Unstable cardiac disease despite treatment, myocardial infarction within 6 months prior to study entry
• History of significant neurologic or psychiatric disorders including dementia or seizures
• Active clinically significant uncontrolled infection
• Active peptic ulcer disease defined as unhealed or clinically active
• Hypercalcemia
• Active drug addiction including alcohol, cocaine or intravenous drug use defined as occurring within the 6 months preceding diagnosis
• Chronic Obstructive Pulmonary Disease, defined as being associated with a hospitalization for pneumonia or respiratory decompensation within 12 months of diagnosis. This does not include obstruction from tumor
• Autoimmune disease requiring therapy, prior organ transplant, or HIV infection
• Interstitial lung disease
• Hepatitis C (test required)

Sponsors & Collaborators

• Icahn School of Medicine at Mount Sinai: lead
• Biodesign Institute: collaborator
• Arizona State University: collaborator

Study Sites (1)

Icahn School of Medicine at Mount Sinai

New York, New York, 10029, United States

Location

Related Publications (36)

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MeSH Terms

Conditions

Carcinoma, Squamous Cell

Interventions

Radiation; Carboplatin

Condition Hierarchy (Ancestors)

Carcinoma; Neoplasms, Glandular and Epithelial; Neoplasms by Histologic Type; Neoplasms; Neoplasms, Squamous Cell

Intervention Hierarchy (Ancestors)

Physical Phenomena; Coordination Complexes; Organic Chemicals

Results Point of Contact

• Title: Dr. Marshall R Posner
• Organization: Icahn School of Medicine at Mount Sinai

marshall.posner@mssm.edu

(212) 659-5461

Study Officials

• Krzysztof Misiukiewicz, M.D.

  Icahn School of Medicine at Mount Sinai

  PRINCIPAL INVESTIGATOR

Publication Agreements

• PI is Sponsor Employee: Yes

Study Design

• Study Type: interventional
• Phase: phase 3
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Associate Professor

Study Record Dates

• First Submitted: September 14, 2012
• First Posted: October 15, 2012
• Study Start: September 1, 2012
• Primary Completion: April 1, 2020
• Study Completion (Estimated): May 1, 2035
• Last Updated: April 9, 2026
• Results First Posted: September 1, 2022

Record last verified: 2026-03

Locations

US (1)