Radiation Therapy and Docetaxel in Treating Patients With HPV-Related Oropharyngeal Cancer

NCT01932697 | Completed Phase 2 Results DMC

• 3 other identifiers: MC1273NCI-2013-0165212-005272
• Study Type: interventional
• Target: 81
• Locations: 1 country
• Sites: 2

Brief Summary

This phase II trial studies how well radiation therapy and docetaxel work in treating patients with human papillomavirus (HPV)-related oropharyngeal cancer. Radiation therapy uses high-energy x-rays to kill tumor cells. Drugs used in chemotherapy, such as docetaxel, work in different ways to stop the growth of tumor cells, either by killing the cells, by stopping them from dividing, or by stopping them from spreading. Giving radiation therapy with docetaxel my kill more tumor cells.

Conditions

Stage I Oropharyngeal Squamous Cell Carcinoma; Human Papillomavirus Infection; Stage II Oropharyngeal Squamous Cell Carcinoma; Stage III Oropharyngeal Squamous Cell Carcinoma; Stage IVA Oropharyngeal Squamous Cell Carcinoma; Stage IVB Oropharyngeal Squamous Cell Carcinoma

Outcome Measures

Primary Outcomes (1)

• 2-year Loco-regional Tumor Control (LRC) Rate

  The 2-year loco-regional tumor control (LRC) rate (percentage) is defined as the percentage of patients with no local/regional recurrence or death 2 years after study registration.

  2 years

Secondary Outcomes (8)

• Incidence of Grade 3 or Higher Mucositis Oral

  4 months post-hyperfractionated radiation therapy

• 2-year Overall Survival (OS) Rate

  2 years

• 2-year Progression-free Survival (PFS)

  From registration to the first of either disease recurrence or death, assessed up to 2 years

• 2-year Distant Metastasis-free Survival Rate

  2 years

• Change From Mean Baseline Score to Mean Score at 12 Months Post-RT in Swallow Function as Measured by the Pharyngeal Total Modified Barium Swallow Impairment Profile.

  12 months

Other Outcomes (2)

• Changes in Transforming Growth Factor (TGF)-beta1 Levels

  Baseline to 1 week post-radiation

• E6/E7 Messenger Ribonucleic Acid (mRNA) of HPV16, Assessed on a Chromogenic RNA in Situ Hybridization (ISH) Assay Called RNAscope

  Baseline

Study Arms (1)

Treatment (docetaxel, hyperfractionated IMRT)

EXPERIMENTAL

Patients receive docetaxel IV over 1 hour on days 1 and 8 and undergo hyperfractionated IMRT BID 5 days a week on days 1-12 for a total of 20 fractions.

Drug: Docetaxel; Radiation: Hyperfractionation; Radiation: Intensity-Modulated Radiation Therapy; Other: Laboratory Biomarker Analysis; Other: Quality-of-Life Assessment

Interventions

Docetaxel DRUG

Given IV

Also known as: Docecad, RP56976, Taxotere, Taxotere Injection Concentrate

Treatment (docetaxel, hyperfractionated IMRT)

Hyperfractionation RADIATION

Undergo hyperfractionated IMRT

Also known as: Hyperfractionated Radiation, Hyperfractionated Radiation Therapy, superfractionated radiation therapy

Treatment (docetaxel, hyperfractionated IMRT)

Intensity-Modulated Radiation Therapy RADIATION

Undergo hyperfractionated IMRT

Also known as: IMRT, Intensity Modulated RT, Intensity-Modulated Radiotherapy

Treatment (docetaxel, hyperfractionated IMRT)

Laboratory Biomarker Analysis OTHER

Correlative studies

Treatment (docetaxel, hyperfractionated IMRT)

Quality-of-Life Assessment OTHER

Ancillary studies

Also known as: Quality of Life Assessment

Treatment (docetaxel, hyperfractionated IMRT)

Eligibility Criteria

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

You may qualify if:

• PRE-REGISTRATION
• Provide written informed consent
• Submission of research blood draw to be stored until after surgical resection of the primary tumor and confirmation of human papilloma virus (HPV) positivity (Mayo Clinic Rochester patients only)
• Patients with oropharynx carcinoma with a smoking history of ˂ 10 pack-year or equivalent 10 year history of tobacco product use and no recent history (within last 5 years) of tobacco use
• REGISTRATION
• Histological confirmation of HPV+ squamous cell carcinoma of the oropharynx; HPV positivity will be defined as positive staining for p16 on immunohistochemistry (IHC)
• Gross total surgical resection with curative intent of the primary tumor and at least unilateral neck dissection within 7 weeks of registration
• Eastern Cooperative Oncology Group (ECOG) performance status (PS) 0 or 1
• Smoking history \< 10 pack years or equivalent 10 year history of tobacco product use
• Absence of distant metastases on standard diagnostic work-up =\< 10 weeks prior to registration; (chest computed tomography \[CT\], chest x-ray \[CXR\], positron emission tomography \[PET\]/CT, etc.)
• Must have one of the following risk factors:
• Lymph node \> 3 cm
• or more positive lymph nodes
• Perineural invasion
• Lymphovascular space invasion

You may not qualify if:

• Any significant tobacco history within the past five years
• Any of the following:
• Pregnant women
• Nursing women
• Men or women of childbearing potential who are unwilling to employ adequate contraception
• Co-morbid systemic illnesses or other severe concurrent disease which, in the judgment of the investigator, would make the patient inappropriate for entry into this study or interfere significantly with the proper assessment of safety and toxicity of the prescribed regimens
• Immunocompromised patients and patients known to be human immunodeficiency virus (HIV) positive
• Uncontrolled intercurrent illness including, but not limited to, ongoing or active infection, symptomatic congestive heart failure, unstable angina pectoris, cardiac arrhythmia, or psychiatric illness/social situations that would limit compliance with study requirements
• Receiving any other investigational agent which would be considered as a treatment for the primary neoplasm
• Other active malignancy =\< 5 years prior to registration; EXCEPTIONS: non-melanotic skin cancer or carcinoma-in-situ of the cervix; NOTE: if there is a history or prior malignancy, they must not be receiving other specific treatment for their cancer
• History of myocardial infarction =\< 180 days prior to registration, or congestive heart failure requiring use of ongoing maintenance therapy for life-threatening ventricular arrhythmias
• Prior history of radiation therapy to the affected site
• History of connective tissue disorders such as rheumatoid arthritis, lupus, or Sjogren's disease
• Presence of any of the following risk factors after surgery:
• Any positive surgical margin

Sponsors & Collaborators

• Mayo Clinic: lead

Study Sites (2)

Mayo Clinic in Arizona

Scottsdale, Arizona, 85259, United States

Location

Mayo Clinic

Rochester, Minnesota, 55905, United States

Location

Related Publications (1)

• Ma DJ, Price KA, Moore EJ, Patel SH, Hinni ML, Garcia JJ, Graner DE, Foster NR, Ginos B, Neben-Wittich M, Garces YI, Chintakuntlawar AV, Price DL, Olsen KD, Van Abel KM, Kasperbauer JL, Janus JR, Waddle M, Miller R, Shiraishi S, Foote RL. Phase II Evaluation of Aggressive Dose De-Escalation for Adjuvant Chemoradiotherapy in Human Papillomavirus-Associated Oropharynx Squamous Cell Carcinoma. J Clin Oncol. 2019 Aug 1;37(22):1909-1918. doi: 10.1200/JCO.19.00463. Epub 2019 Jun 4.

  PMID: 31163012 DERIVED

MeSH Terms

Conditions

Papillomavirus Infections; Squamous Cell Carcinoma of Head and Neck

Interventions

Docetaxel; Radiotherapy, Intensity-Modulated

Condition Hierarchy (Ancestors)

Sexually Transmitted Diseases, Viral; Sexually Transmitted Diseases; Communicable Diseases; Infections; DNA Virus Infections; Virus Diseases; Tumor Virus Infections; Genital Diseases; Urogenital Diseases; Disease Attributes; Pathologic Processes; Pathological Conditions, Signs and Symptoms; Carcinoma, Squamous Cell; Carcinoma; Neoplasms, Glandular and Epithelial; Neoplasms by Histologic Type; Neoplasms; Head and Neck Neoplasms; Neoplasms by Site

Intervention Hierarchy (Ancestors)

Taxoids; Cyclodecanes; Cycloparaffins; Hydrocarbons, Alicyclic; Hydrocarbons, Cyclic; Hydrocarbons; Organic Chemicals; Diterpenes; Terpenes; Radiotherapy, Conformal; Radiotherapy, Computer-Assisted; Radiotherapy; Therapeutics

Results Point of Contact

• Title: Daniel J. Ma, M.D.
• Organization: Mayo Clinic

Ma.Daniel@mayo.edu

507/284-3261

Study Officials

• Daniel Ma

  Mayo Clinic

  PRINCIPAL INVESTIGATOR

Publication Agreements

• PI is Sponsor Employee: Yes

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: August 27, 2013
• First Posted: August 30, 2013
• Study Start: September 4, 2013
• Primary Completion: October 20, 2016
• Study Completion: December 28, 2021
• Last Updated: February 10, 2026
• Results First Posted: September 18, 2019

Record last verified: 2023-09

Locations

US (2)