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A clinical research study comparing two cisplatin dosing schedules combined with radiation for patients with advanced head and neck cancer.
EU CTIS ID: 2024-515237-15-00
What this study is testing
Phase II: > To determine whether radiation with cisplatin weekly is superior in terms of acute toxicity, as measured by the T-scores (TAME method), to radiation with cisplatin every 3 weeks for patients with locoregionally advanced squamous cell carcinoma of the head and neck (SCCHN). Phase III: > To determine whether radiation with cisplatin weekly is non-inferior to radiation with cisplatin every 3 weeks in terms of overall survival (OS) for patients with locoregionally advanced SCCHN. > To determine whether radiation with cisplatin weekly is superior in terms of acute toxicity, as measured by the T-scores (TAME method), to radiation with cisplatin every 3 weeks for patients with locoregionally advanced SCCHN.
- Phase II and Phase III (Integrated)
A plain-language read of the study's public EU CTIS listing. The study team confirms the details.
Who can take part
You may be able to join if
- 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.
- 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.
- Negative urine or serum pregnancy test (in persons of childbearing potential) within 14 days prior to registration.
- 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.
- The patient or a legally authorized representative must provide study-specific informed consent prior to study entry.
- Patients must have clinically or radiographically evident measurable disease at the primary site or at nodal stations.
You likely can't join if
- Patients with oral cavity cancer, nasopharynx cancer, or p16-negative cancer of unknown primary (CUP);
- Recurrence of the study cancer;
- Definitive clinical or radiologic evidence of distant metastatic disease;
- 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;
- 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 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);
See the full eligibility criteria
- 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.
- 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.
- Negative urine or serum pregnancy test (in persons of childbearing potential) within 14 days prior to registration.
- 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.
- The patient or a legally authorized representative must provide study-specific informed consent prior to study entry.
- Patients must have clinically or radiographically evident measurable disease at the primary site or at nodal stations.
- Clinical stage (AJCC, 8th ed.) as indicated in the trial protocol, including no distant metastases based diagnostic workup.
- Age ≥ 18;
- Zubrod (ECOG) performance status of 0-1 within 14 days prior to registration;
- Adequate hematologic function within 30 days prior to registration defined in the trial protocol.
- Adequate renal function within 30 days prior to registration (per protocol definition).
- 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.
- 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.
- Patients with oral cavity cancer, nasopharynx cancer, or p16-negative cancer of unknown primary (CUP);
- Recurrence of the study cancer;
- Definitive clinical or radiologic evidence of distant metastatic disease;
- 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;
- 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 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);
- Pregnancy and individuals unwilling to discontinue nursing.
- 8 History of hypersensitivity to cisplatin or platinum-containing compounds.
The study team makes the final eligibility decision.
Where it's taking place
- Switzerland
- United States
- Hong Kong
- Canada
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, 65+ years, 18-64 years. The study team makes the final eligibility decision.
Where is this trial taking place?
Study sites include Switzerland; United States; Hong Kong; Canada. Enter your location above to see the nearest site and check your eligibility.
Explore other conditions
BridgeMD is an information and trial-matching tool - not medical advice, and not the study sponsor. Details come from EU CTIS; the study team decides eligibility.