Head and Neck Cancer
Conditions
Keywords
Head and Neck cancer
Brief summary
The purpose of this study is to test whether the use of advanced radiation therapy delivery techniques can spare a patient's normal tissue, including salivary glands, from radiation. This study is being done to try to reduce radiation side effects, especially mouth dryness, which happens with standard radiation methods. In order to reduce these side effects, other normal tissues may receive a different radiation dose (sometimes more) than what would have been received using standard radiation therapy. A secondary goal of this study is to determine if the type of tumor a patient has can be controlled at least as well (or better) using this advanced radiation therapy delivery technique as it would be if the patient was treated with standard radiation therapy.
Detailed description
Studies show that a dose response relationship in the salivary glands exists and that it may be possible to improve significantly post-radiation xerostomia and quality of life if radiation techniques can be devised that would spare the salivary glands while adequately treating the targets. A new treatment modality (computer-optimized IMRT) facilitates increased sparing of noninvolved tissue, specifically the sparing of both parotid glands, and more conformal high-dose delivery to the bilateral neck targets in patients with head and neck cancer. This study will evaluate the benefits regarding xerostomia-specific and general QOL in patients receiving head and neck RT using this modality. Assessment of swallowing dysfunction and aspiration will be made using videofluoroscopy. In addition, this study will evaluate the pattern of local/regional tumor recurrence, to assess whether sparing both parotid glands may cause tumor recurrence in spared neck areas.
Interventions
RADIATIONIMRT
DRUGPaclitaxel
DRUGCarboplatin
DRUGCisplatin
DRUG5-Fluorouracil
Sponsors
University of Michigan Rogel Cancer Center
Study design
Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
TREATMENT
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
Inclusion criteria
* All patients must have histologically confirmed invasive cancer of the head and neck. * Irradiation to both neck sides is required. * Standard radiation techniques would irradiate most of both parotid glands to a high dose (\>50 Gy). Patients with oropharyngeal, oral, nasopharyngeal, hypopharyngeal and advanced laryngeal cancer are expected to fulfill this requirement. * Patients with resectable disease that is either measurable, evaluable or non-measurable disease (post-operative) will be eligible. * Karnofsky performance status \>60 * Patients receiving or not receiving chemotherapy are eligible. * All patients must sign an informed consent. * Pre-treatment laboratory criteria: * WBC (White Blood Cell) \> 3500/ul, granulocyte \> 1500/ul. * Platelet count \> 100,000/ul. * Creatinine clearance \> 60 cc/min. to receive cisplatin; creatinine clearance 30-59 cc/min to receive carboplatin. * Bilirubin \< 1.5 mg% with no evidence of obstructive liver disease. * AST (Aspartate Aminotransferase) and ALT (Alanine Aminotransferase) equal to or less than 2.5 x upper limit of normal.
Exclusion criteria
* Patients who received past irradiation to the head and neck are not eligible. * Prior head and neck malignancy or history of other prior non-head and neck malignancy within the past 3 years. * Prior head and neck radiation or prior chemotherapy. * Documented evidence of distant metastases. * Active infection. * Pregnancy or lactation; patients must use effective contraception during the course of the clinical trial. * Any medical or psychiatric illness which in the opinion of the principal investigator would compromise the patients ability to tolerate this treatment. * Patients residing in prison. * Age \< 18 years.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Percentage of Participants With Grade 0-1 Observer-rated Dysphagia | 12 months | To objectively assess dysphagia and aspiration in patients receiving dysphagia/aspiration-sparing IMRT concurrent with chemotherapy, the percentage of participants with observer-rated dysphagia was calculated. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| The Mean Esophageal Radiotherapy Dose in Patients With Strictures and Without Strictures | 5 years | To assess the relationships between the mean radiotherapy dose delivered and objectively measured dysphagia. |
Countries
United States
Participant flow
Pre-assignment details
90 participants were enrolled however only 80 started treatment. Only 73 participants completed treatment. 7 did not complete the 12 month post radiation therapy (RT)swallowing studies.
Participants by arm
| Arm | Count |
|---|---|
| Chemo-IMRT Chemotherapy:
Chemotherapy will consist of Paclitaxel 30mg/m² IV over 1 hour, followed by Carboplatin (AUC 1) IV over 30 minutes, or Carboplatin 100mg/m² per IV over 30 minutes or Cisplatin 100mg/m² per IV over 1 hour, or Cisplatin (80mg/m²) or Carboplatin (AUC 5) IV on day 1 and 5-Fluorouracil (1000mg/m²) as a 24-hour continuous infusion, daily x 4 days.
Intensity-modulated Radiation Therapy (IMRT):
Primary RT: 70 Gy to gross disease and 56-63 Gy to subclinical disease in 35 fractions.
Post-operative RT: 64 Gy to high-risk targets (postoperative tumor bed, first-echelon nodes) and 57.6 Gy to low-risk targets, in 32 fractions. | 73 |
| Total | 73 |
Withdrawals & dropouts
| Period | Reason | FG000 |
|---|---|---|
| Overall Study | Did not complete 12 mon post RT studies | 7 |
Baseline characteristics
| Characteristic | Chemo-IMRT |
|---|---|
| Age, Continuous | 55 years |
| AJCC Stage Stage III | 9 participants |
| AJCC Stage Stage IVA | 58 participants |
| AJCC Stage Stage IVB | 6 participants |
| Gross Tumor Volume | 110 mL |
| N Stage Stage 0 | 6 participants |
| N Stage Stage 1 | 6 participants |
| N Stage Stage 2 | 55 participants |
| N Stage Stage 3 | 6 participants |
| Sex: Female, Male Female | 8 Participants |
| Sex: Female, Male Male | 65 Participants |
| Smoking Status Current Smoker | 16 participants |
| Smoking Status Never Smoked | 26 participants |
| Smoking Status Previous Smoker | 31 participants |
| T Stage Stage 1 | 9 participants |
| T Stage Stage 2 | 29 participants |
| T Stage Stage 3 | 17 participants |
| T Stage Stage 4 | 18 participants |
| Tumor Location Base of Tongue | 38 participants |
| Tumor Location Tonsil | 35 participants |
Adverse events
| Event type | EG000 affected / at risk |
|---|---|
| deaths Total, all-cause mortality | — / — |
| other Total, other adverse events | 0 / 73 |
| serious Total, serious adverse events | 26 / 73 |
Outcome results
Primary
Percentage of Participants With Grade 0-1 Observer-rated Dysphagia
To objectively assess dysphagia and aspiration in patients receiving dysphagia/aspiration-sparing IMRT concurrent with chemotherapy, the percentage of participants with observer-rated dysphagia was calculated.
Time frame: 12 months
Population: 90 patients were enrolled. Only 80 patients were treated and 7 patients did not complete the 12 month post-Radiation Therapy (RT) swallowing studies. Therefore only 73 patients were analyzed.
| Arm | Measure | Value (NUMBER) |
|---|---|---|
| Chemo-IMRT | Percentage of Participants With Grade 0-1 Observer-rated Dysphagia | 94 percentage of participants |
Secondary
The Mean Esophageal Radiotherapy Dose in Patients With Strictures and Without Strictures
To assess the relationships between the mean radiotherapy dose delivered and objectively measured dysphagia.
Time frame: 5 years
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Chemo-IMRT | The Mean Esophageal Radiotherapy Dose in Patients With Strictures and Without Strictures | Patients with Strictures (N=5) | 48 Gray (Gy) | Standard Deviation 17 |
| Chemo-IMRT | The Mean Esophageal Radiotherapy Dose in Patients With Strictures and Without Strictures | Patients without strictures (N=68) | 27 Gray (Gy) | Standard Deviation 12 |