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The purpose of this study is to determine the utility of kilovoltage (kV) cone beam CT imaging to track the dose delivered in head and neck cancer patients, to assess the benefit of cone beam CT to patients set-up for radiation treatment, to determine how shifts based on kV cone beam CT compare to the standard approach (orthogonal pair), and to develop remote access tools (preferably internet-based) so that the MD can approve these plans in real time.
The investigators' secondary objectives for this study are to assess the possibility of using kV cone beam for treatment replanning as compared to standard the treatment planning, to determine the need and feasibility of adaptive radiation therapy, to develop concept of establishing cumulative DVH (C-DVH) with daily updates and compare it to planned DVH (P-DVH), to identify tolerance margins, to evaluate local control, locoregional control, distant metastasis, and overall survival, to assess patient quality of life,and to develop predictors of patients which may benefit from ART.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| definitive radiation + concomitant chemo | Experimental | Concurrent chemo + IGRT: These patients will have chemotherapy during the time of radiation treatment |
|
| neoadjuvant chemo | Experimental | Neoadjuvant chemo + IGRT: These patients will have chemotherapy prior to other radiation treatment. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| concurrent chemo + IGRT | Radiation |
| ||
| neoadjuvant chemo + IGRT |
| Measure | Description | Time Frame |
|---|---|---|
| Clinical patient response | This will assessed by CT scan or MRI 4-5 weeks post concurrent chemo. | From the date of initiation of radiation therapy, until date of first progression or until date of death (approximately 5 years). |
| Measure | Description | Time Frame |
|---|---|---|
| Patient quality of life | This will be assessed using the: Fact Head & Neck form at baseline, and weekly throughout radiation treatment. | During radiation therapy (7-9 weeks) |
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Inclusion Criteria:
Patients should have an ECOG (Eastern Clinical Oncology Group) performance status of 0-2
Patients should meet at least one of the following criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Ken Hu, MD | Beth Israel Medical Center | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Beth Israel Medical Center | New York | New York | 10003 | United States |
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| ID | Term |
|---|---|
| D006258 | Head and Neck Neoplasms |
| ID | Term |
|---|---|
| D009371 | Neoplasms by Site |
| D009369 | Neoplasms |
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| ID | Term |
|---|---|
| D061089 | Radiotherapy, Image-Guided |
| ID | Term |
|---|---|
| D011878 | Radiotherapy |
| D013812 | Therapeutics |
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| Radiation |
|