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

Completed · Phase 2

Conditions studied: Squamous Cell Carcinoma of the Head and Neck

In brief

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.

Key facts

Study ID

NCT02031250

Run by

University of Michigan Rogel Cancer Center

People needed

106

Starts

2014-02-01

Expected to finish

2023-02-22

Last updated by the study team

2026-03-02

Who can join

Age: 18 and older. Sex: any. Healthy volunteers: not accepted.

You may qualify if…

• 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:
• 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.
• HPV(-) (Human Papillomavirus) or p16(-) locally/regionally advanced (T3-4 or N2-3) oropharyngeal cancer.
• HPV(+) or p16(+) locally/regionally advanced (T4 or N3) oropharyngeal cancer.
• T3 or T4 laryngeal or hypopharyngeal cancer that is locally advanced, bulky (>40 cc*), unresectable, or patient declines surgery.
• Stage III/IV oral cavity or paranasal sinus cancers in patients who refuse surgery or are unfit for surgery.
• 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.

You may not qualify if…

• 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.

Where it is running

• Veterans Affairs (VA) Ann Arbor Healthcare System — Ann Arbor, Michigan, United States
• University of Michigan Hospital — Ann Arbor, Michigan, United States

Full record on ClinicalTrials.gov

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