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Compares treatment options for Locally Advanced Head and Neck Squamous Cell Carcinoma
Official title Low-Dose Weekly vs High-Dose Cisplatin
ClinicalTrials.gov ID: NCT03649048
What this study is testing
What is High-Dose Cisplatin?
High-Dose Cisplatin is an investigational medicine, given as an once-weekly infusion into a vein, being studied as a potential treatment for locally advanced head and neck squamous cell carcinoma.
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 study is a prospective open-label randomized clinical trial. Following informed consent eligible LASCCHN patients (n=100) planned for CRT will be stratified by tumor p16 status and then randomized in a 1:1 fashion to either concurrent HD cisplatin or concurrent weekly LD cisplatin.
- 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
- Age 18 or older
- Willing and able to provide written informed consent
- Eastern Cooperative Oncology Group (ECOG) performance status 0-2
- Histologically or cytologically confirmed squamous cell carcinoma
- Primary tumor site includes oral cavity, oropharynx, nasal cavity, salivary glands (excluding parotid), hypopharynx, or larynx and primary unknown
You likely can't join if
- Serious medical comorbidities or other contraindications to radiotherapy and/or chemotherapy.
- Prior history of head and neck cancer within 5 years.
- Nasopharyngeal primary confirmed or suspected.
- Severe hearing loss as determined clinically Pre-existing use of hearing aids.
- Peripheral neuropathy .grade 2 (CTCAE v4.02).
- Prior or planned neoadjuvant chemotherapy prior to CRT.
See the full eligibility criteria
- Age 18 or older
- Willing and able to provide written informed consent
- Eastern Cooperative Oncology Group (ECOG) performance status 0-2
- Histologically or cytologically confirmed squamous cell carcinoma
- Primary tumor site includes oral cavity, oropharynx, nasal cavity, salivary glands (excluding parotid), hypopharynx, or larynx and primary unknown
- Patients must be deemed suitable for HD cisplatin therapy based on tumor characteristics, clinical condition and comorbidities in the judgement of the treating medical oncologist.
- Patients must be planned to receive radical intent radiation treatment based on clinical condition, comorbidities and tumor characteristics in the judgment of the treating radiation oncologist
- Adequate organ and marrow function independent of transfusion for at least 7 days prior to randomization defined as:
- Hemoglobin \> 80 g/L; Absolute neutrophil count \>1.5x10⁹ /L, platelets \>100x10⁹/L; Bilirubin \ 50 ml/min Males: Creatinine Clearance = Weight (kg) x (140 - Age) (mL/min) 72 x serum creatinine (mg/dL) Females...
- Patient must be assessed at head and neck cancer multidisciplinary clinic (with assessment by radiation oncologist and surgeon) and presented at multidisciplinary tumor board prior to randomization.
- Serious medical comorbidities or other contraindications to radiotherapy and/or chemotherapy.
- Prior history of head and neck cancer within 5 years.
- Nasopharyngeal primary confirmed or suspected.
- Severe hearing loss as determined clinically Pre-existing use of hearing aids.
- Peripheral neuropathy .grade 2 (CTCAE v4.02).
- Prior or planned neoadjuvant chemotherapy prior to CRT.
- Prior head and neck radiation at any time.
- Distant metastatic disease.
- Inability to attend full course of radiotherapy or follow-up visits.
- Prior invasive malignant disease unless disease-free for at least 5 years or more, with the exception of non-melanoma skin cancer or in-situ carcinoma.
- Unable or unwilling to complete QOL questionnaires.
- Pregnant or lactating women.
- Unable to use dual method of contraception.
The study team makes the final eligibility decision.
Where it's taking place
- Hamilton, Ontario, Canada
- London, Ontario, Canada
- Toronto, Ontario, 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, 18 years and older. The study team makes the final eligibility decision.
Where is this trial taking place?
Study sites include Hamilton, Ontario, Canada; London, Ontario, Canada; Toronto, Ontario, 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 ClinicalTrials.gov; the study team decides eligibility.