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Randomized Phase II Study of DCE-MRI-based Dose Escalation for Poor-prognosis and Neck Cancer

NCT02031250

Description:

This study aims to improve locoregional control of poor prognosis Head and Neck Cancer (HNC) patients by selectively escalating the radiotherapy dose to subvolumes of tumor likely to be resistant to standard Radiation Therapy (RT) using DCE-MRI (Dynamic Contrast Enhanced Magnetic Resonance Imaging). Standard doses of radiotherapy to the rest of the tissues and surrounding normal tissues will be maintained.

Related Conditions:
  • Head and Neck Squamous Cell Carcinoma
  • Nasopharyngeal Squamous Cell Carcinoma
  • Oropharyngeal Squamous Cell Carcinoma
Recruiting Status:

Recruiting

Phase:

Phase 2

Trial Eligibility

Document

Randomized Phase II Study of DCE-MRI-based Dose Escalation for Poor-prognosis and Neck Cancer

Title

  • Brief Title: Randomized Phase II Study of DCE-MRI-based Dose Escalation for Poor-prognosis and Neck Cancer
  • Official Title: Randomized Phase II Study of DCE-MRI-based Dose Escalation for Poor-prognosis and Neck Cancer
  • Clinical Trial IDs

    NCT ID: NCT02031250

    ORG ID: UMCC 2013.062

    NCI ID: HUM00074305

    Trial Conditions

    Squamous Cell Carcinoma of the Head and Neck

    Trial Interventions

    Drug Synonyms Arms
    Cisplatin Control Arm, Boost Arm
    Carboplatin Control Arm, Boost Arm

    Trial Purpose

    This study aims to improve locoregional control of poor prognosis Head and Neck Cancer (HNC)
    patients by selectively escalating the radiotherapy dose to subvolumes of tumor likely to be
    resistant to standard Radiation Therapy (RT) using DCE-MRI (Dynamic Contrast Enhanced
    Magnetic Resonance Imaging). Standard doses of radiotherapy to the rest of the tissues and
    surrounding normal tissues will be maintained.

    Detailed Description

    Trial Arms

    Name Type Description Interventions
    Control Arm Active Comparator Standard chemotherapy (Cisplatin or Carboplatin) and IMRT (Intensity-Modulated Radiation Therapy) Cisplatin, Carboplatin
    Boost Arm Experimental Boost radiation to hypoperfused volumes in addition to standard chemotherapy (Cisplatin or Carboplatin) and IMRT (Intensity-Modulated Radiation Therapy) Cisplatin, Carboplatin

    Eligibility Criteria

    Inclusion Criteria:

    - Patients must have pathologicallyconfirmed, previously untreated, nonmetastatic
    locally/regionally advanced squamous cell carcinoma of the head and neck, stage
    III/IV, referred for definitive chemoRT, and meet one of the following six criteria:

    1. Primary tumor and/or metastatic lymph nodes are: unresectable, resection is
    considered by the treating surgeon or patient to result in unacceptable
    functional or oncological results, patient refuses surgery, or surgery is not
    possible due to comorbidities.

    2. HPV() (Human Papillomavirus) or p16(-) locally/regionally advanced (T34 or
    N23) oropharyngeal cancer.

    3. HPV(+) or p16(+) locally/regionally advanced (T4 or N3) oropharyngeal cancer
    with >10 pack year smoking history.

    4. Locally advanced, bulky (>6 cc*) T3 or T4 laryngeal or hypopharyngeal cancer in
    patients who decline surgery.

    5. Stage III/IV oral cavity or paranasal sinus cancers in patients who refuse
    surgery or are unfit for surgery.

    6. Locally/regionally advanced (stage T34 and/or N3) nasopharyngeal cancer which
    is EBV () (EpsteinBarr Virus).

    - KPS (Karnofsky Performance Status: A measure of general well being and activities of
    daily living; scores range from 0 to 100 where 100 represents perfect health) >70
    (see Appendix A) within two weeks of enrollment.

    - Pretreatment laboratory criteria within four weeks of enrollment:

    - WBC (White Blood Cell) > 3500/ul, granulocyte > 1500/ul.

    - Platelet count > 100,000/ul.

    - Total Bilirubin < 1.5 X ULN.

    - AST (Aspartate Aminotransferase) and ALT (Alanine Aminotransferase) < 2.5 X ULN.

    - Estimated Creatinine clearance >30cc/min.

    - Patients must be able to receive protocol chemotherapy in the judgment of the
    treating Medical Oncologist.

    - Patients are adults (Age >18).

    - All patients must be informed of the investigational nature of this study and given
    written informed consent in accordance with institutional and federal guidelines.

    Exclusion Criteria:

    - EBV (+) Nasopharyngeal Carcinoma.

    - Prior head and neck radiation.

    - Documented evidence of distant metastases.

    - Patients with active infection.

    - Pregnant women.

    - Patients should have no contraindications to having a contrast enhanced MRI scan.
    These contraindications will be assessed at the time of enrollment using the
    guidelines set up and in clinical use by the Institutional Standard Practice.

    Minimum Eligible Age: 18 Years

    Maximum Eligible Age: N/A

    Eligible Gender: Both

    Primary Outcome Measures

    Disease Free Survival (DSF) time

    Secondary Outcome Measures

    Local-regional control rate

    Proportion of patients in which hypoperfused subvolumes overlap with recurrence volumes

    Number of patients with adverse events

    Correlation coefficient between continuous dose and perfusion summary measures

    Trial Keywords