Phase 2 Head and Neck Cancer Trial, Recruiting

Written by an AI model from ClinicalTrials.gov eligibility criteria and checked on a sample basis. Please confirm against the original criteria.

Who might be able to join this trial:

• The treatment plan must include radiation therapy combined with cisplatin chemotherapy as the main (definitive) treatment — not as treatment given after surgery.
• At least two specific areas of the mouth or throat (such as the tongue, tonsils, soft palate, hard palate, cheeks, lips, floor of the mouth, or retromolar trigone) must be receiving a radiation dose of 50 Gy or more, as confirmed by the treating doctor.
• A laboratory or tissue test must have confirmed a type of cancer called squamous cell carcinoma, located in the oropharynx, larynx, hypopharynx, nasopharynx, or oral cavity (throat, voice box, or mouth areas).
• For oropharynx cancer specifically, test results for HPV and/or a protein called P16 must be available and documented.
• The cancer must be a known, confirmed primary tumour — cases where the original tumour location is unknown are not eligible.
• There must be no clear signs that the cancer has spread to distant parts of the body (no metastatic disease).
• The radiation plan must use a technique called IMRT, given once per weekday in doses of 2.0 Gy, reaching a total dose of 70 Gy.
• The person must be aged 18 or older.
• The person must have a general health/activity level rating (Zubrod score) of 0, 1, or 2, meaning they are able to carry out at least some daily activities (confirm with trial site).
• Potassium and magnesium levels in the blood must meet the hospital's minimum normal levels — replacement therapy is allowed if levels can be brought up to the required range.
• Blood counts must meet minimum levels: neutrophils at least 1,500 cells/mm³, platelets at least 100,000 cells/mm³, and haemoglobin at least 9.0 g/dL (a blood transfusion to reach 10.0 g/dL or above is permitted).
• Kidney function must be adequate, with a creatinine clearance score above 50 mL/min as calculated by a standard formula.
• Liver function tests must be within acceptable ranges: total bilirubin no more than twice the upper normal limit (except for people with Gilbert's syndrome), and two liver enzymes (AST and ALT) no more than three times the upper normal limit.
• People with the ability to become pregnant must have a documented definition of childbearing potential on file (confirm with trial site for specific requirements).

Who may not be able to join:

• People who have previously had radiation therapy to an area that would overlap with the planned new radiation treatment fields.
• People currently taking nitrates or other medications that could cause a sudden, dangerous drop in blood pressure, in the treating doctor's judgement.
• People who have already had surgery that removed all visible cancer from both the primary site and the lymph nodes (for example, tonsil removal or full lymph node removal), leaving no measurable disease remaining.
• People currently receiving chemotherapy and radiation after surgery (adjuvant post-operative chemoradiation).
• People who have taken medications that strongly affect a specific liver enzyme system (cytochrome P450 inducers or strong inhibitors) within 4 days before registering for the trial — with some exceptions such as steroids for nausea or certain antifungal medicines like nystatin, fluconazole, miconazole, and clotrimazole.
• People who have previously received induction chemotherapy (chemotherapy given before the main treatment).
• People currently being treated for an unrelated cancer, with some exceptions for very early-stage or low-risk cancers such as cervical carcinoma in situ, basal cell skin cancer, certain thyroid cancers, early bladder cancers, or low-risk prostate cancer.
• People with significant hearing loss that would prevent the safe use of cisplatin, as assessed by their doctor.
• People who have had a serious heart or stroke-related event in the past 6 months, such as a stroke, heart attack, unstable chest pain, uncontrolled heart rhythm problems, or moderate-to-severe heart failure.
• People with valvular heart disease (a problem with the heart's valves).
• People with significant blood vessel disease, such as a large aortic aneurysm or a recent blood clot in an artery, within the past 6 months.
• People with a history or current signs of central nervous system conditions (such as uncontrolled seizures) unrelated to cancer.
• People who have had a serious bacterial, viral, or fungal infection requiring intravenous antibiotics within 7 days before enrolling.
• People who have been hospitalised for a lung condition such as a COPD flare-up or other breathing illness within 30 days before registering.
• People with a personal or family history of a heart rhythm condition called Long QT Syndrome, or whose ECG (heart tracing) shows a prolonged QT interval on two or more recordings in the past 3 months (above 450 ms for males or 470 ms for females).
• People with severe electrolyte (blood mineral) abnormalities that cannot be corrected to a mild level with supplementation.
• People with poorly controlled high blood pressure (above 160/95 on two measurements within 30 days before registering).
• People with moderate or severe mouth sores (oral mucositis grade 2 or higher) at the time of registration.
• People with moderate or severe low blood pressure (hypotension grade 2 or higher) at the time of registration.
• People who medically require certain heart rhythm medications that carry a risk of prolonging the QT interval, including but not limited to amiodarone, quinidine, dofetilide, sotalol, flecainide, and lidocaine.
• People who require any other medications listed as prohibited in the trial protocol, including low-level laser therapy (LLLT) for mouth sores and certain other mucositis treatments such as glutamine.
• People with a known allergic reaction to the study drug or to chemically or biologically similar compounds.

Important: Always verify eligibility with the trial site directly before applying.