Randomized Phase II Study of DCE-MRI-based Dose Escalation for Poor-prognosis and Neck Cancer
- Conditions
- Squamous Cell Carcinoma of the Head and Neck
- Interventions
- Radiation: IMRT (Intensity-Modulated Radiation Therapy)Radiation: Boost Radiation to Hypoperfused Volumes
- Registration Number
- NCT02031250
- Lead Sponsor
- University of Michigan Rogel Cancer Center
- 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.
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- ACTIVE_NOT_RECRUITING
- Sex
- All
- Target Recruitment
- 106
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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).
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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.
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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.
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Patients must be able to receive protocol chemotherapy in the judgment of the treating Medical Oncologist.
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Patients are adults (Age ≥18).
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All patients must be informed of the investigational nature of this study and given written informed consent in accordance with institutional and federal guidelines.
- 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.
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- PARALLEL
- Arm && Interventions
Group Intervention Description Boost Arm Boost Radiation to Hypoperfused Volumes Boost radiation to hypoperfused/low-diffusion volumes in addition to standard chemotherapy (Cisplatin or Carboplatin) and IMRT (Intensity-Modulated Radiation Therapy) Control Arm Cisplatin Standard chemotherapy (Cisplatin or Carboplatin) and IMRT (Intensity-Modulated Radiation Therapy) Boost Arm IMRT (Intensity-Modulated Radiation Therapy) Boost radiation to hypoperfused/low-diffusion volumes in addition to standard chemotherapy (Cisplatin or Carboplatin) and IMRT (Intensity-Modulated Radiation Therapy) Control Arm IMRT (Intensity-Modulated Radiation Therapy) Standard chemotherapy (Cisplatin or Carboplatin) and IMRT (Intensity-Modulated Radiation Therapy) Boost Arm Carboplatin Boost radiation to hypoperfused/low-diffusion volumes in addition to standard chemotherapy (Cisplatin or Carboplatin) and IMRT (Intensity-Modulated Radiation Therapy) Control Arm Carboplatin Standard chemotherapy (Cisplatin or Carboplatin) and IMRT (Intensity-Modulated Radiation Therapy) Boost Arm Cisplatin Boost radiation to hypoperfused/low-diffusion volumes in addition to standard chemotherapy (Cisplatin or Carboplatin) and IMRT (Intensity-Modulated Radiation Therapy)
- Primary Outcome Measures
Name Time Method Disease Free Survival (DSF) time 3 years post treatment Kaplan-Meier curves with point-wise 90% confidence intervals will be generated for each treatment arm, overall and by strata. Estimates with confidence intervals will be generated from these curves for the usual summary statistics, including median DFS times and DFS at 1, 2, and 3 years.
- Secondary Outcome Measures
Name Time Method Number of patients with adverse events 3 years post treatment Acute and late toxicities will be summarized descriptively by grade and type for each treatment group. The proportion of patients experiencing certain toxicity types will be calculated with score based confidence intervals. Chi-square tests will be used to test whether the proportion of patients with toxicity differs between treatment groups.
Proportion of patients in which hypoperfused/low-diffusion subvolumes overlap with recurrence volumes 3 years post treatment Local-regional control rate 3 years post-treatment Compare local-regional control rates between the two arms at 1, 2 and 3 years. Local-regional control is defined as the absence of local-regional progression.
Correlation coefficient between continuous dose and perfusion summary measures 2 weeks post Radiation Therapy (RT) Pearson or Spearman rank based correlation between the continuous dose and perfusion summary measures
Trial Locations
- Locations (2)
University of Michigan Hospital
🇺🇸Ann Arbor, Michigan, United States
Veterans Affairs (VA) Ann Arbor Healthcare System
🇺🇸Ann Arbor, Michigan, United States