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New treatment option for Head and Neck Squamous Cell Carcinoma
Official title Radiation Therapy With or Without Cisplatin in Treating Patients With Stage III-IVA Squamous Cell Carcinoma of the Head and Neck Who Have Undergone Surgery
ClinicalTrials.gov ID: NCT02734537
What this study is testing
What is Cisplatin?
Cisplatin is an investigational medicine, given as an once-weekly infusion into a vein, being studied as a potential treatment for head and neck squamous cell carcinoma.
Also referred to as Abiplatin, Blastolem.
Plain-language explanation of the investigational treatment - it is being studied and is not an approved or proven therapy. The study team can confirm the details.
- What it's testing
- This phase II trial studies how well radiation therapy with or without cisplatin works in treating patients with stage III-IVA squamous cell carcinoma of the head and neck who have undergone surgery. Radiation therapy uses high energy x-rays to kill tumor cells and shrink tumors.
- Phase 2: a mid-size study of how well it works
- Which group you join is decided by chance.
A plain-language read of the study's public ClinicalTrials.gov listing. The study team confirms the details.
Who can take part
Ages 18 and older
You may be able to join if
- PRE-REGISTRATION (STEP 0)
- Pathologically proven diagnosis of squamous cell carcinoma (including variants such as verrucous carcinoma, spindle cell carcinoma, carcinoma not...
- Patient has undergone total resection of the primary tumor with curative intent
- NOTE: Patient is to be pre-registered to screening (Step 0) and tissue submitted to Foundation Medicine as soon as possible after surgery in order to...
- For oropharynx primary tumors, the patient must have negative human papillomavirus (HPV) status of the tumor as determined by p16 protein expression...
See the full eligibility criteria
- PRE-REGISTRATION (STEP 0)
- Pathologically proven diagnosis of squamous cell carcinoma (including variants such as verrucous carcinoma, spindle cell carcinoma, carcinoma not otherwise specified [NOS]) of the head/neck (oral cavity, oropharynx...
- Patient has undergone total resection of the primary tumor with curative intent
- NOTE: Patient is to be pre-registered to screening (Step 0) and tissue submitted to Foundation Medicine as soon as possible after surgery in order to meet the 8 week deadline to register the patient to Step 1 after...
- For oropharynx primary tumors, the patient must have negative human papillomavirus (HPV) status of the tumor as determined by p16 protein expression using immunohistochemistry (IHC)
- Patients with, per the operative and/or pathology report, positive margin(s) (tumor present at the cut or inked edge of the tumor) which is not superceded by an additional margin of tumor-negative tissue, nodal...
- A paraffin-embedded surgical tumor tissue specimen has been located is available for shipment to Foundation Medicine, Inc. following pre-registration
- NOTE: Complete the EA3132-specific FoundationOne requisition form
- Patients with a history of a curatively treated malignancy must be disease-free for at least two years except for carcinoma in situ of cervix and/or non-melanomatous skin cancer; patients must not have received...
- Patient must not have had previous irradiation to the head and neck that would result in overlap in radiation fields for the current disease
- Patients with recurrent disease or multiple primaries are ineligible
- RANDOMIZATION (STEP 1)
- NOTE: Patient must meet all eligibility criteria outlined in pre-registration; patient may not be assigned by chance until site has been notified that the central determination of p53 mutation status of the surgical...
- Per the operative report, the gross total resection of the primary tumor with curative intent was completed within 8 weeks prior to randomization
- The patient must have the following assessments done =\< 8 weeks prior to randomization:
- Examination by a head and neck surgeon
- Chest x-ray (or chest computed tomography [CT] scan or CT/positron emission tomography [PET] of the chest or magnetic resonance imaging [MRI]) to rule out distant metastatic disease
- Patient has Eastern Cooperative Oncology Group (ECOG) performance status 0-1 within 2 weeks prior to randomization
- Women must not be pregnant or breast-feeding; females of childbearing potential must have a blood or urine study within 2 weeks prior to randomization to rule out pregnancy; a female of childbearing potential is any...
- Women of childbearing potential and sexually active males must be strongly advised to use an accepted and effective method of contraception or to abstain from sexual intercourse for the duration of their participation...
- Absolute neutrophil count \>= 1,500/mm\^3 within 4 weeks prior to randomization
- Platelets \>= 100,000/mm\^3 within 4 weeks prior to randomization
- Total bilirubin =\< the upper limit of normal (ULN) within 4 weeks prior to randomization
- Calculated creatinine clearance must be \> 60 ml/min using the Cockcroft-Gault formula within 4 weeks prior to randomization
- Patient must not have an intercurrent illness likely to interfere with protocol therapy
The study team makes the final eligibility decision.
Where it's taking place
- Birmingham, Alabama, United States
- Anchorage, Alaska, United States
- Phoenix, Arizona, United States
- Tucson, Arizona, United States
- Fort Smith, Arkansas, United States
- Hot Springs, Arkansas, United States
- Little Rock, Arkansas, United States
- Arroyo Grande, California, United States
- Burbank, California, United States
- Carmichael, California, United States
- Elk Grove, California, United States
- Irvine, California, United States
- La Jolla, California, United States
- Merced, California, United States
- Orange, California, United States
- Palm Springs, California, United States
- Rocklin, California, United States
- Sacramento, California, United States
- San Luis Obispo, California, United States
- Santa Maria, California, United States
+ 429 more site(s).
Questions & answers
Do participants get paid in this trial?
This listing doesn't specify compensation. Many trials still reimburse travel or offer a stipend, so it's worth asking the study team when you connect.
Is it free to join, and do I need insurance?
Searching and applying through BridgeMD is free. In clinical trials the study-related treatment and visits are generally provided at no cost to you. You usually don't need insurance to take part - confirm specifics with the study team.
How long does this study last?
The listing doesn't state an exact length. The study team walks you through the schedule and number of visits before you decide to enroll.
Who can join this trial?
This study is enrolling all sexes, 18 years and older. The study team makes the final eligibility decision.
Where is this trial taking place?
Study sites include Birmingham, Alabama, United States; Anchorage, Alaska, United States; Phoenix, Arizona, United States; Tucson, Arizona, United States; Fort Smith, Arkansas, United States; Hot Springs, Arkansas, United States and 443 more location(s). Enter your location above to see the nearest site and check your eligibility.
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BridgeMD is an information and trial-matching tool - not medical advice, and not the study sponsor. Details come from ClinicalTrials.gov; the study team decides eligibility.