Description:
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.
Title
- Brief Title: Randomized Phase II Study of DCE-MRI-based Dose Escalation for Poor-prognosis and Neck Cancer
- Official Title: Randomized Phase II Study of DCE-MRI-based Dose Escalation for Poor-prognosis and Neck Cancer
Clinical Trial IDs
- ORG STUDY ID:
UMCC 2013.062
- SECONDARY ID:
HUM00074305
- NCT ID:
NCT02031250
Conditions
- Squamous Cell Carcinoma of the Head and Neck
Interventions
| Drug | Synonyms | Arms |
|---|
| Cisplatin | | Boost Arm |
| Carboplatin | | Boost Arm |
Purpose
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.
Trial Arms
| Name | Type | Description | Interventions |
|---|
| Control Arm | Active Comparator | Standard chemotherapy (Cisplatin or Carboplatin) and IMRT (Intensity-Modulated Radiation Therapy) | |
| Boost Arm | Experimental | Boost radiation to hypoperfused volumes in addition to standard chemotherapy (Cisplatin or Carboplatin) and IMRT (Intensity-Modulated Radiation Therapy) | |
Eligibility Criteria
Inclusion Criteria:
- Patients must have pathologically-confirmed, previously untreated, 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.
| Maximum Eligible Age: | N/A |
| Minimum Eligible Age: | 18 Years |
| Eligible Gender: | All |
| Healthy Volunteers: | No |
Primary Outcome Measures
| Measure: | Disease Free Survival (DSF) time |
| Time Frame: | 3 years post treatment |
| Safety Issue: | |
| Description: | 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
| Measure: | Local-regional control rate |
| Time Frame: | 3 years post-treatment |
| Safety Issue: | |
| Description: | 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. |
| Measure: | Proportion of patients in which hypoperfused subvolumes overlap with recurrence volumes |
| Time Frame: | 3 years post treatment |
| Safety Issue: | |
| Description: | |
| Measure: | Number of patients with adverse events |
| Time Frame: | 3 years post treatment |
| Safety Issue: | |
| Description: | 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. |
| Measure: | Correlation coefficient between continuous dose and perfusion summary measures |
| Time Frame: | 2 weeks post Radiation Therapy (RT) |
| Safety Issue: | |
| Description: | Pearson or Spearman rank based correlation between the continuous dose and perfusion summary measures |
Details
| Phase: | Phase 2 |
| Primary Purpose: | Interventional |
| Overall Status: | Active, not recruiting |
| Lead Sponsor: | University of Michigan Rogel Cancer Center |
Last Updated
January 28, 2021
