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

NCT ID: NCT02031250

Last Updated: 2023-08-31

Basic Information

• Recruitment Status: UNKNOWN
• Clinical Phase: PHASE2
• Total Enrollment: 106 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2014-02-28
• Study Completion Date: 2023-12-31

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.

Conditions

Squamous Cell Carcinoma of the Head and Neck

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: NONE

Study Groups

Control Arm

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

Group Type: ACTIVE_COMPARATOR

Cisplatin

Intervention Type: DRUG

Cisplatin 40mg/m2 administered as an IV infusion prior to radiotherapy on day 1 of each week of chemo-irradiation

Carboplatin

Intervention Type: DRUG

Patients considered medically unfit to receive Cisplatin as determined by the prescribing physician, will receive Carboplatin via IV infusion on day 1 of each week of chemo-irradiation

IMRT (Intensity-Modulated Radiation Therapy)

Intervention Type: RADIATION

Boost Arm

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

Group Type: EXPERIMENTAL

Cisplatin

Intervention Type: DRUG

Cisplatin 40mg/m2 administered as an IV infusion prior to radiotherapy on day 1 of each week of chemo-irradiation

Carboplatin

Intervention Type: DRUG

Patients considered medically unfit to receive Cisplatin as determined by the prescribing physician, will receive Carboplatin via IV infusion on day 1 of each week of chemo-irradiation

IMRT (Intensity-Modulated Radiation Therapy)

Intervention Type: RADIATION

Boost Radiation to Hypoperfused Volumes

Intervention Type: RADIATION

Interventions

Cisplatin

Cisplatin 40mg/m2 administered as an IV infusion prior to radiotherapy on day 1 of each week of chemo-irradiation

Intervention Type: DRUG

Carboplatin

Patients considered medically unfit to receive Cisplatin as determined by the prescribing physician, will receive Carboplatin via IV infusion on day 1 of each week of chemo-irradiation

Intervention Type: DRUG

IMRT (Intensity-Modulated Radiation Therapy)

Intervention Type: RADIATION

Boost Radiation to Hypoperfused Volumes

Intervention Type: RADIATION

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.

• Minimum Eligible Age: 18 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

National Institutes of Health (NIH)

NIH

Sponsor Role: collaborator

University of Michigan Rogel Cancer Center

OTHER

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Michelle Mierzwa, M.D.

Role: PRINCIPAL_INVESTIGATOR

University of Michigan Rogel Cancer Center

Locations

Veterans Affairs (VA) Ann Arbor Healthcare System

Ann Arbor, Michigan, United States

University of Michigan Hospital

Ann Arbor, Michigan, United States

Countries

United States

Other Identifiers

HUM00074305

Identifier Type: OTHER

Identifier Source: secondary_id

UMCC 2013.062

Identifier Type: -

Identifier Source: org_study_id