Comparison of Radiation Therapy and Chemotherapy Combinations for Treatment of Oral Cancer

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"You are invited to be a part of this study if you have Stage III or IV Oral Cancer."
Age: 18 years or older
Gender:
Any
Healthy Volunteers: No
Keywords: Stage III Squamous Cell Carcinoma of the Hypopharynx, Stage III Squamous Cell Carcinoma of the Larynx, Stage III Squamous Cell Carcinoma of the Lip and Oral Cavity, Stage III Squamous Cell Carcinoma of the Oropharynx, Stage III Verrucous Carcinoma of the Larynx, Stage III Verrucous Carcinoma of the Oral Cavity, Stage IV Squamous Cell Carcinoma of the Hypopharynx, Stage IVA Squamous Cell Carcinoma of the Larynx, Stage IVA Squamous Cell Carcinoma of the Lip and Oral Cavity, Stage IVA Squamous Cell Carcinoma of the Oropharynx, Stage IVA Verrucous Carcinoma of the Larynx, Stage IVA Verrucous Carcinoma of the Oral Cavity, Stage IVB Squamous Cell Carcinoma of the Larynx, Stage IVB Squamous Cell Carcinoma of the Lip and Oral Cavity, Stage IVB Squamous Cell Carcinoma of the Oropharynx, Stage IVB Verrucous Carcinoma of the Larynx, Stage IVB Verrucous Carcinoma of the Oral Cavity, Tongue Cancer
Type: Drug study, Phase [/2/,/ /3/]
Target:
15 Participants
Investigator:
Description
You are invited to be a part of this study if you have Stage III or IV Oral Cancer.

The purpose this study is to find out the good and/or bad effects of the following treatments on you and your cancer.

In this study, you will receive one of the following treatments:
• Standard treatment: radiation therapy and Cisplatin
• Experimental treatment: radiation therapy and Docetaxel
• Experimental treatment: radiation therapy, Docetaxel, and Cetuximab

Cisplatin and Docetaxel are standard chemotherapy drugs for your type of cancer. The dose and treatment schedule of Docetaxel given in this study is experimental. Cetuximab is a drug that blocks the epidermal growth factor. Epidermal growth factor is a protein that affects cancer growth and many other functions.
This study requires

This study requires several medical visits, tests, and procedures. This includes but is not limited to blood tests, CT scans, and radiotherapy. Your physician will discuss in detail with you the visits, tests, and procedures you will need to undergo in this study.

PART I Eligible participants will be "randomized" into one of the study groups described below. Randomization means that you are put into a group by chance.

If you are in Group 1, you will receive radiation therapy once a day, Monday through Friday, for about 6 weeks. Each treatment will be given in Radiation Oncology. It will take approximately 15-20 minutes to complete.

You will also receive cisplatin once a week for 6 weeks (a total of 6 doses). The first treatment with cisplatin will be administered intravenously (through a needle in your vein) over 7 hours and then over 6 hours for cycles 2-6.

If you are in Group 2, you will receive radiation therapy once a day, Monday through Friday, for about 6 weeks. Each treatment will be given in Radiation Oncology. It will take approximately 15-20 minutes to complete.

You will also receive docetaxel once a week for 6 cycles. The first treatment with docetaxel will be administered intravenously (though a needle in your vein) over 5 hours and all treatments after that will take approximately 2.5 hours.

If you are in Group 3, you will receive radiation therapy once a day, Monday through Friday, for about 6 weeks. Each treatment will take approximately 15-20 minutes to complete.

You will also receive docetaxel once a week for 6 cycles and cetuximab for a total of 7 doses.

PART II This part of the study will proceed only if certain results are achieved in the first part of the study.

Eligible participants will be "randomized" into one of the study groups described below. Randomization means that you are put into a group by chance. A computer program will place you in one of the study groups. Neither you nor your study doctor can choose the group you will be in. You will have an equal chance of being placed in one of the 2 groups.

If you are in Group 1, you will receive radiation therapy once a day, Monday through Friday, for about 6 weeks. You will also receive cisplatin once a week for 6 weeks (a total of 6 doses). This will be administered the same way as it was described in the section entitled “First part of study”.

If you are in Group 2, you will receive one of the experimental treatments described above. These treatments will all be administered the same way as they were described in the section entitled “First part of study”.

Who can participate

Inclusion Criteria:

  • Pathologically (histologically or cytologically) proven diagnosis of head and neck squamous cell carcinoma (HNSCC) involving the oral cavity (excluding lips), oropharynx (p16 negative), larynx, or hypopharynx within 63 days of registration
  • Patients must have undergone gross total surgical resection of high-risk oral cavity, oropharynx (p16 negative), larynx, or hypopharynx within 63 days prior to registration
  • Patients must have at least 1 of the following high-risk pathologic features: extracapsular nodal extension or invasive cancer at the primary tumor resection margin (tumor or ink)
  • Pathologic stage III or IV head and neck squamous cell carcinoma (HNSCC), including no distant metastases, based upon the following minimum diagnostic workup:
  • General history and physical examination by a radiation oncologist and/or medical oncologist within 84 days prior to registration;
  • Examination by an ear nose throat (ENT) or head & neck surgeon prior to surgery; a laryngopharyngoscopy (mirror and/or fiber optic and/or direct procedure), if appropriate is recommended but not required. Intra-operative examination is acceptable documentation.
  • Pre-op Imaging of the head and neck: A neck computed tomography (CT) (with contrast) or CT/positron emission tomography (PET) (with contrast) and/or an magnetic resonance imaging (MRI) of the neck (T1 with Gadolinium and T2) within 84 days prior to surgery; note: this imaging data (diagnostic pre-operative scan showing gross disease) is to be submitted in Digital Imaging and Communications in Medicine (DICOM) format via TRIAD; the report is to be uploaded into Rave
  • Chest CT scan (with or without contrast) or CT/PET that includes the chest (with or without contrast) either within 84 days prior to surgery or within 120 days prior to registration; NOTE: If the CT/PET with or without contrast is done within 84 days prior to surgery, if fulfills the chest imaging requirement.
  • Zubrod performance status of 0-1 within 14 days prior to registration
  • Absolute granulocyte count (AGC) >= 1,500 cells/mm^3
  • Platelets >= 100,000 cells/mm^3
  • Hemoglobin >= 8.0 g/dl (Note: The use of transfusion or other intervention to achieve hemoglobin [Hgb] >= 8.0 g/dl is acceptable)
  • Total bilirubin < 2 x institutional upper limit of normal (ULN) within 14 days prior to registration
  • Aspartate aminotransferase (AST) or alanine aminotransferase (ALT) < 3 x institutional ULN within 14 days prior to registration
  • Serum creatinine institutional ULN within 14 days prior to registration or; creatinine clearance (CC) >= 50 ml/min within 14 days prior to registration determined by 24-hour collection or estimated by Cockcroft-Gault formula
  • Negative serum or urine pregnancy test within 14 days prior to registration for women of childbearing potential
  • The following assessments are required within 14 days prior to registration: sodium (Na), potassium (K), chloride (Cl), glucose, calcium (Ca), magnesium (Mg), and albumin; Note: Patients with an initial magnesium < 0.5 mmol/L (1.2 mg/dl) may receive corrective magnesium supplementation but should continue to receive either prophylactic weekly infusion of magnesium and/or oral magnesium supplementation (eg, magnesium oxide) at the investigator's discretion
  • Patients with feeding tubes are eligible for the study
  • Women of childbearing potential and male participants who are sexually active must agree to use a medically effective means of birth control
  • Patient must provide study specific informed consent prior to study entry, including consent for mandatory tissue submission for epidermal growth factor receptor (EGFR) analysis and for oropharyngeal cancer patients, human papilloma virus (HPV) analysis

Exclusion Criteria:

  • Prior invasive malignancy (except non-melanomatous skin cancer) unless disease free for a minimum of 1095 days (3 years); noninvasive cancers (for example, carcinoma in situ of the breast, oral cavity, or cervix are all permissible) are permitted even if diagnosed and treated < 3 years ago
  • Patients with simultaneous primaries or bilateral tumors are excluded, with the exception of patients with bilateral tonsil cancers or patients with T1-2, N0, M0 resected differentiated thyroid carcinoma, who are eligible
  • Prior systemic chemotherapy or anti-epidermal growth factor (EGF) therapy for the study cancer; note that prior chemotherapy for a different cancer is allowable
  • Prior radiotherapy to the region of the study cancer that would result in overlap of radiation therapy fields
  • Severe, active co-morbidity, defined as follows:
  • Unstable angina and/or congestive heart failure requiring hospitalization within 6 months prior to registration
  • Transmural myocardial infarction within 6 months prior to registration
  • Acute bacterial or fungal infection requiring intravenous antibiotics at the time of registration
  • Chronic obstructive pulmonary disease exacerbation or other respiratory illness requiring hospitalization or precluding study therapy at the time of registration
  • Idiopathic pulmonary fibrosis or other severe interstitial lung disease that requires oxygen therapy or is thought to require oxygen therapy within 1 year prior to registration
  • Hepatic insufficiency resulting in clinical jaundice and/or coagulation defects; note, however, that laboratory tests for coagulation parameters are not required for entry into this protocol
  • Acquired immune deficiency syndrome (AIDS) based upon current Centers for Disease and Control (CDC) definition; note: HIV testing is not required for entry into this protocol; the need to exclude patients with AIDS from this protocol is necessary because the treatments involved in this protocol may be significantly immunosuppressive; protocol-specific requirements may also exclude immuno-compromised patients
  • Grade 3-4 electrolyte abnormalities (Common Terminology Criteria for Adverse Events [CTCAE], v. 4):
  • Serum calcium (ionized or adjusted for albumin) 12.5 mg/dl (> 3.1 mmol/L) despite intervention to normalize levels
  • Glucose 250 mg/dl (> 14mmol/L)
  • Magnesium 3 mg/dl (> 1.23 mmol/L) despite intervention to normalize levels
  • Potassium 6 mmol/L despite intervention to normalize levels
  • Sodium 155 mmol/L despite intervention to normalize levels
  • Pregnancy or women of childbearing potential and men who are sexually active and not willing/able to use medically acceptable forms of contraception; this exclusion is necessary because the treatment involved in this study may be significantly teratogenic
  • Prior allergic reaction to cetuximab
Benefits and risks of participating
BENEFITS:

We can promise no benefits to you from participating in this research.


RISKS:

Your physician will review all the risks of this study with you.
Compensation
You will not be paid for taking part in this study.
Resources
Schedule
Study duration and period
The treatment portion of this study will last up to 7 weeks. You also will be asked to visit the office for follow-up exams at 1 and 3 months after the completion of radiation therapy, then every 3 months for 2 years, every 6 months for 3 years, then once a year for your lifetime.
Recruitment period
From June 24, 2013
Location
UC Davis Medical Center
2315 Stockton Boulevard
Sacramento, CA 95817
Research Topic
Conditions:
  • Head and Neck Cancer

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