Clinical Trials /

Image-Guided Stereotactic Radiosurgery (SRS) Boost for HPV-Oropharyngeal Cancer

NCT02703493

Description:

This is a Phase I study looking to evaluate the safety of dose escalated stereotactic radiotherapy (SRS) without exceeding the maximum tolerated dose in patients with high-risk human papilloma virus (HPV)- unassociated oropharyngeal squamous cancer.

Related Conditions:
  • Oropharyngeal Squamous Cell Carcinoma
Recruiting Status:

Active, not recruiting

Phase:

N/A

Trial Eligibility

Document

Image-Guided Stereotactic Radiosurgery (SRS) Boost for HPV-Oropharyngeal Cancer

Title

  • Brief Title: Image-Guided Stereotactic Radiosurgery (SRS) Boost for HPV-Oropharyngeal Cancer
  • Official Title: A Phase I Trial of IMRT With Dose-Escalated Image-Guided Stereotactic Radiosurgery (SRS) Boost for Human Papilloma Virus (HPV)- Unassociated Oropharyngeal Cancer
  • Clinical Trial IDs

    NCT ID: NCT02703493

    ORG ID: 09-309A

    Trial Conditions

    Cancer of the Oropharynx

    Trial Interventions

    Drug Synonyms Arms

    Trial Purpose

    This is a Phase I study looking to evaluate the safety of dose escalated stereotactic
    radiotherapy (SRS) without exceeding the maximum tolerated dose in patients with high-risk
    human papilloma virus (HPV)- unassociated oropharyngeal squamous cancer.

    Detailed Description

    Human Papilloma Virus (HPV) is frequently found within tumor cells removed from patients
    diagnosed with oropharynx cancer. Tumors which do not contain HPV virus (termed
    "HPV-Negative") are not cured as frequently by radiation therapy. Tumors which do contain
    HPV in patients who have a history of cigarette smoking also are not cured as frequently by
    radiation.

    One way to potentially overcome this challenge is to deliver a more intense dose of
    radiation treatment to the tumor. The standard way to deliver radiation, termed Intensity
    Modulated Radiotherapy (IMRT), can protect normal tissues near tumors to a certain degree
    but not completely. Stereotactic radiosurgery (SRS) is a technique which can deliver
    radiation more precisely.

    This trial will test the safety of treating HPV-unassociated oropharynx tumors to higher
    radiation doses wth SRS (termed a "boost") after a standard course of IMRT has been given.
    In addition, the investigators will look at whether magnetic resonance imaging (MRI)
    scanning can detect treatment response in oropharynx tumors earlier than with standard
    tests.

    Trial Arms

    Name Type Description Interventions
    Cohort 1 Experimental Patients will receive 6 weeks of Intensity-Modulated Radiation Therapy (IMRT) (standard of care) followed by the dose escalated stereotactic radiosurgery (SRS Boost). Cohort 1 will receive 8 Gy in a single fraction, cohort 2 will receive 10 Gy in a single fraction and cohort 3 will receive 10 Gy split into two fractions.

    Eligibility Criteria

    Inclusion Criteria:

    - Patients older than 18 years of age with histologically proven squamous cell
    carcinoma of the oropharynx

    - HPV-negative disease status by routine p16 immunohistochemical (IHC) staining or in
    situ hybridization (ISH) of biopsied tumor tissue or >10 pack-year cigarette smoking
    history

    - Stage T1-4, N0-3 disease, as defined by American Joint Committee on Cancer (AJCC)
    criteria

    - Eastern Cooperative Oncology Group (ECOG) (Zubrod) Performance Status 0-2.

    Exclusion Criteria:

    - Patients who have undergone resection of primary disease

    - Patients who have received induction chemotherapy for their oropharynx cancer
    diagnosis

    - Prior cancer diagnosis within 5 years, except appropriately treated localized
    epithelial skin cancer or cervical cancer

    - Prior radiation therapy to the head and neck region

    - Women of childbearing potential (a woman of child-bearing potential is a sexually
    mature woman who has not undergone a hysterectomy or who has not been naturally
    postmenopausal for at least 24 consecutive months [i.e., who has had menses at any
    time in the preceding 24 months]) and male participants must practice effective
    contraception (oral, injectable, or implantable hormonal contraceptive; tubal
    ligation; intra-uterine device; barrier contraceptive with spermicide; or
    vasectomized partner) throughout the study

    - Patient unable to tolerate MRI or having an estimated Glomerular Filtration Rate
    (GFR) <60 ml/min/1.73 m2.

    - Severe, active co-morbidity, defined as follows:

    - Unstable angina and/or congestive heart failure requiring hospitalization within the
    last 6 months

    - Transmural myocardial infarction within the last 6 months

    - Acute bacterial or fungal infection requiring intravenous antibiotics at the time of
    registration

    - Chronic Obstructive Pulmonary Disease exacerbation or other respiratory illness
    requiring hospitalization or precluding study therapy within 30 days before
    registration

    - Hepatic insufficiency resulting in clinical jaundice and/or coagulation defects;
    note, however, that laboratory tests for liver function and coagulation parameters
    are not required for entry into this protocol

    - Acquired Immune Deficiency Syndrome (AIDS) based upon current Centers for Disease
    Control (CDC) definition; note, however, that HIV testing is not required for entry
    into this protocol. The need to exclude patients with AIDS from this protocol is
    necessary because the treatments involved in this protocol may be significantly
    immunosuppressive. Protocol-specific requirements may also exclude immuno-compromised
    patients

    - History or treatment with potent immunosuppressive drugs for such conditions as organ
    transplant, severe rheumatoid arthritis, etc. within the past 6 months.

    Minimum Eligible Age: 18 Years

    Maximum Eligible Age: N/A

    Eligible Gender: Both

    Primary Outcome Measures

    Safety and dose-limiting toxicity of dose escalated stereotactic radiotherapy in patients with high-risk oropharyngeal squamous cancer using (CTCAE), version 4.03

    Secondary Outcome Measures

    Disease response using Revised RECIST guideline (version 1.1)

    Trial Keywords