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

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

NCT ID: NCT02031250

Condition: Squamous Cell Carcinoma of the Head and Neck

Conditions: Official terms:
Squamous Cell Carcinoma of Head and Neck
Carboplatin

Study type: Interventional

Study phase: Phase 2

Overall status: Active, not recruiting

Study design:

Allocation: Randomized

Intervention model: Parallel Assignment

Primary purpose: Treatment

Masking: None (Open Label)

Intervention:

Intervention type: Drug
Intervention name: Cisplatin
Description: Cisplatin 40mg/m2 administered as an IV infusion prior to radiotherapy on day 1 of each week of chemo-irradiation
Arm group label: Boost Arm
Arm group label: Control Arm

Intervention type: Drug
Intervention name: Carboplatin
Description: 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
Arm group label: Boost Arm
Arm group label: Control Arm

Intervention type: Radiation
Intervention name: IMRT (Intensity-Modulated Radiation Therapy)
Arm group label: Boost Arm
Arm group label: Control Arm

Intervention type: Radiation
Intervention name: Boost Radiation to Hypoperfused Volumes
Arm group label: Boost Arm

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.

Criteria for 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.

Gender: All

Minimum age: 18 Years

Maximum age: N/A

Healthy volunteers: No

Locations:

Facility:
Name: Veterans Affairs (VA) Ann Arbor Healthcare System

Address:
City: Ann Arbor
Zip: 48105
Country: United States

Facility:
Name: University of Michigan Hospital

Address:
City: Ann Arbor
Zip: 48109
Country: United States

Start date: February 2014

Completion date: December 2023

Lead sponsor:
Agency: University of Michigan Rogel Cancer Center
Agency class: Other

Collaborator:
Agency: National Institutes of Health (NIH)
Agency class: NIH

Source: University of Michigan Rogel Cancer Center

Record processing date: ClinicalTrials.gov processed this data on November 12, 2024

Source: ClinicalTrials.gov page: https://clinicaltrials.gov/ct2/show/NCT02031250