A clinical research study comparing two cisplatin dosing schedules combined with radiation for patients with advanced head and neck cancer.
- Conditions
- ocoregionally Advanced Squamous Cell Carcinoma of the Head and Neck (SCCHN): Pathologically (histologically or cytologically) proven diagnosis of squamous cell carcinoma of the head and neck (SCCHN) of the oropharynx, larynx, hypopharynx, or p16-positive unknown primary.MedDRA version: 21.0Level: PTClassification code 10041823Term: Squamous cell carcinomaSystem Organ Class: 10029104 - Neoplasms benign, malignant and unspecified (incl cysts and polyps)Therapeutic area: Diseases [C] - Cancer [C04]
- Registration Number
- EUCTR2022-004130-19-IE
- Lead Sponsor
- Cancer Trials Ireland
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- Authorised-recruitment may be ongoing or finished
- Sex
- All
- Target Recruitment
- 1250
1. Pathologically (histologically or cytologically) proven diagnosis of squamous cell carcinoma of the head and neck (SCCHN) of the oropharynx, larynx, hypopharynx, or p16-positive unknown primary.
2. Patients must have clinically or radiographically evident measurable disease at the primary site or at nodal stations.
3. Clinical stage (AJCC, 8th ed.) as indicated in the trial protocol, including no distant metastases based diagnostic workup.
4. Age = 18;
5. Zubrod (ECOG) performance status of 0-1 within 14 days prior to registration;
6. Adequate hematologic function within 30 days prior to registration defined in the trial protocol.
7. Adequate renal function within 30 days prior to registration (per protocol definition).
8. Adequate hepatic function within 30 days prior to registration defined as follows:
• Total bilirubin = 1.5 x institutional upper limit of normal (ULN) (not applicable to patients with known Gilbert’s syndrome);
• AST and ALT = 1.5 x institutional ULN.
9. Known human immunodeficiency virus (HIV) infected patients on effective anti-retroviral therapy with undetectable viral load within 6 months and CD4 T Cell count > 200 cells/mm3 are eligible for this trial. Testing is not required for entry into protocol.
10. Patients with a prior or concurrent malignancy whose natural history or treatment does not have the potential to interfere with the safety or efficacy assessment of the investigational regimen are eligible for this trial.
11. Negative urine or serum pregnancy test (in persons of childbearing potential) within 14 days prior to registration.
12. Willing to use highly effective contraceptives for participants of childbearing potential (participants who may become pregnant or who may impregnate a partner) during therapy and for 14 months (females); for 11 months (males) following last dose of cisplatin.
13. The patient or a legally authorized representative must provide study-specific informed consent prior to study entry.
Are the trial subjects under 18? no
Number of subjects for this age range:
F.1.2 Adults (18-64 years) yes
F.1.2.1 Number of subjects for this age range 625
F.1.3 Elderly (>=65 years) yes
F.1.3.1 Number of subjects for this age range 625
1. Patients with oral cavity cancer, nasopharynx cancer, or p16-negative cancer of unknown primary (CUP);
2. Recurrence of the study cancer;
3. Definitive clinical or radiologic evidence of distant metastatic disease;
4. Prior systemic chemotherapy for the study cancer; note that prior chemotherapy for a different cancer is allowable, however, any prior exposure to cisplatin is excluded;
5. Prior radiotherapy to the region of the study cancer that would result in overlap of radiation therapy fields;
6. Severe, active co-morbidity defined as follows:
• Unstable angina requiring hospitalization in the last 6 months;
• Myocardial infarction within the last 6 months;
• New York Heart Association Functional Classification III/IV (Note: Patients with known history or current symptoms of cardiac disease, or history of treatment with cardiotoxic agents, should have a clinical risk assessment of cardiac function using the New York Heart Association Functional Classification.);
• Persistent Grade 3-4 (CTCAE version 5.0) electrolyte abnormalities that cannot be reversed despite replacement as indicated by repeat testing;
• Patient must not have an active infection requiring IV antibiotics prior to registration;
• Other chronic renal disease like nephrotic syndrome, that could be worsened by cisplatin therapy;
• History of allogenic organ transplantation;
• Any symptomatic peripheral sensory neuropathy Grade = 2 (CTCAE version 5.0);
7. Pregnancy and individuals unwilling to discontinue nursing.
8. History of hypersensitivity to cisplatin or platinum-containing compounds.
Study & Design
- Study Type
- Interventional clinical trial of medicinal product
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method
- Secondary Outcome Measures
Name Time Method