Clinical trial NCT02031250: 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
Study type: INTERVENTIONAL
Overall status: ACTIVE_NOT_RECRUITING
Phase: PHASE2
Conditions: Squamous Cell Carcinoma of the Head and Neck
Lead sponsor: University of Michigan Rogel Cancer Center
Sponsor class: OTHER
Collaborators: name: National Institutes of Health (NIH)
First posted: 2014-01-09
Enrollment: 106
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: 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.


Eligibility criteria: Inclusion Criteria:

* Patients must have pathologically-confirmed, non-metastatic locally/regionally advanced squamous cell carcinoma of the head and neck, stage III/IV, referred for definitive chemo-RT, and meet one of the following six criteria:

  1. Primary tumor (T4) with or without metastatic lymph nodes. Tumor or 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 (T3-4 or N2-3) oropharyngeal cancer.
  3. HPV(+) or p16(+) locally/regionally advanced (T4 or N3) oropharyngeal cancer.
  4. T3 or T4 laryngeal or hypopharyngeal cancer that is locally advanced, bulky (\>40 cc\*), unresectable, or patient declines 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 T3-4 and/or N3) nasopharyngeal cancer which is EBV (-) (Epstein-Barr 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.
* Pre-treatment 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 in the protocol treated tumor.
* 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.

Primary outcomes:
measure: Disease Free Survival (DSF) time
timeFrame: 3 years post treatment
Secondary outcomes:
measure: Local-regional control rate
timeFrame: 3 years post-treatment
measure: Proportion of patients in which hypoperfused/low-diffusion subvolumes overlap with recurrence volumes
timeFrame: 3 years post treatment
measure: Number of patients with adverse events
timeFrame: 3 years post treatment
measure: Correlation coefficient between continuous dose and perfusion summary measures
timeFrame: 2 weeks post Radiation Therapy (RT)
Other outcomes:
Locations:
city: Ann Arbor
country: United States
facility: Veterans Affairs (VA) Ann Arbor Healthcare System
state: Michigan
city: Ann Arbor
country: United States
facility: University of Michigan Hospital
state: Michigan
Study officials:
affiliation: University of Michigan Rogel Cancer Center
name: Michelle Mierzwa, M.D.
role: PRINCIPAL_INVESTIGATOR
References: