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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
Conditions: official terms
Carcinoma, Squamous Cell - Head and Neck Neoplasms
Study Type
Interventional
Study Phase
Phase 2
Study Design
Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Treatment
Intervention
Name: Cisplatin
Type: Drug
Name: Carboplatin
Type: Drug
Name: IMRT (Intensity-Modulated Radiation Therapy)
Type: Radiation
Name: Boost Radiation to Hypoperfused Volumes
Type: Radiation
Overall Status
Recruiting
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
Healthy Volunteers: No
Maximum Age: N/A
Minimum Age: 18 Years
Gender: Both
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 and/or metastatic lymph 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) locally/regionally advanced (T3‐4 or N2‐3) oropharyngeal cancer.
3. HPV(+) locally/regionally advanced (T4 or N3) oropharyngeal cancer.
4. Locally advanced, bulky (>6 cc*) T3 or T4 laryngeal or hypopharyngeal cancer in patients who decline 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 enrolment:
- 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 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.
- Prior head and neck malignancy within the past 3 years. Patients with skin cancer or early stage treated prostate cancer are eligible to participate.
- Prior head and neck radiation or chemotherapy.
- 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.
- 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 and/or metastatic lymph 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) locally/regionally advanced (T3‐4 or N2‐3) oropharyngeal cancer.
3. HPV(+) locally/regionally advanced (T4 or N3) oropharyngeal cancer.
4. Locally advanced, bulky (>6 cc*) T3 or T4 laryngeal or hypopharyngeal cancer in patients who decline 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 enrolment:
- 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 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.
- Prior head and neck malignancy within the past 3 years. Patients with skin cancer or early stage treated prostate cancer are eligible to participate.
- Prior head and neck radiation or chemotherapy.
- 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.
Locations
University of Michigan Hospital
Ann Arbor, Michigan, United States
Veterans Affairs (VA) Ann Arbor Healthcare System
Status: Recruiting
Contact: Avraham Eisbruch, M.D. - 734-936-4302
Ann Arbor, Michigan, United States
Status: Not yet recruiting
Contact: Cora Edwards, C.C.R.P. - 734-222-8607
Start Date
February 2014
Sponsors
University of Michigan Cancer Center
Source
University of Michigan Cancer Center
Record processing date
ClinicalTrials.gov processed this data on July 28, 2015
ClinicalTrials.gov page