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

University of Michigan Rogel Cancer Center

Status and phase: Active, not recruiting; Phase 2

Conditions: Squamous Cell Carcinoma of the Head and Neck

Treatments: Drug: Cisplatin; Radiation: IMRT (Intensity-Modulated Radiation Therapy); Drug: Carboplatin; Radiation: Boost Radiation to Hypoperfused Volumes

Study type: Interventional

Funder types: Other; NIH

Identifiers

NCT02031250

HUM00074305 (Other Identifier)

UMCC 2013.062

Details and patient eligibility

About

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.

Enrollment: 106 patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

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.

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: None (Open label)

---

106 participants in 2 patient groups

Control Arm

Active Comparator group

Description:

Standard chemotherapy (Cisplatin or Carboplatin) and IMRT (Intensity-Modulated Radiation Therapy)

Treatment:

Drug: Cisplatin

Radiation: IMRT (Intensity-Modulated Radiation Therapy)

Drug: Carboplatin

Boost Arm

Experimental group

Description:

Boost radiation to hypoperfused/low-diffusion volumes in addition to standard chemotherapy (Cisplatin or Carboplatin) and IMRT (Intensity-Modulated Radiation Therapy)

Treatment:

Drug: Cisplatin

Radiation: IMRT (Intensity-Modulated Radiation Therapy)

Radiation: Boost Radiation to Hypoperfused Volumes

Drug: Carboplatin