Recruiting

Low-Dose vs. High-Dose

Sponsor:

London Health Sciences Centre Research Institute OR Lawson Research Institute of St. Joseph's

Code:

NCT03649048

Conditions

Locally Advanced Head and Neck Squamous Cell Carcinoma

Eligibility Criteria

Sex: All

Age: 18+

Healthy Volunteers: Not accepted

Interventions

High-Dose Cisplatin

Low-Dose Cisplatin

Radiotherapy

Study Details

Brief summary:

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.

Conditions

Locally Advanced Head and Neck Squamous Cell Carcinoma

Study ID

NCT03649048

Start date

Nov 5, 2018

Status verified date

Jul, 2025

Completion date

Sep, 2028

Anticipated

Primary completion date

Sep, 2028

Anticipated

Eligibility Criteria

Eligibility Criteria

Sex: All

Age: 18+

Healthy Volunteers: Not accepted

Inclusion 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 < 35 umol/L; AST or ALT < 3 x the upper limit of normal; Calculated creatinine clearance (as determined by Cockcroft- Gault) > 50 ml/min

Males:

Creatinine Clearance = Weight (kg) x (140 - Age) (mL/min) 72 x serum creatinine (mg/dL)

Females:

Creatinine Clearance = Weight (kg) x (140 - Age) x 0.85 (mL/min) 72 x serum creatinine (mg/dL)

  • 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.

Exclusion Criteria:

  • 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.

Study Design

Enrollment

100 participants

Anticipated

Allocation

Randomized

Intervention Model

Parallel Assignment

Primary purpose

Supportive Care

Interventions and Outcome Measures

Arms

active comparator: ARM 1: High-Dose Cisplatin days 1, 22 & 43 with radiotherapy

active comparator: ARM 2: Low-Dose Cisplatin Q 1 wk + radiotherapy

Interventions

High-Dose Cisplatin

Intravenous administration of High-Dose Cisplatin

Low-Dose Cisplatin

Intravenous administration of Low-Dose Cisplatin

Radiotherapy

Participating centres are to follow their local radiation treatment planning and delivery techniques.

Primary outcome measure

  • Hearing related quality of life (QOL) [ Time Frame: 1-year post start of treatment ]
  • Hearing related quality of life (QOL) [ Time Frame: 1-year post start of treatment ]
  • Compare Incidence of > Grade 2 hearing loss [ Time Frame: At 1 year post start of treatment ]
  • Compare Incidence of > Grade 1 hearing loss [ Time Frame: At 1 year post start of treatment ]

Central Contacts and Locations

Central contacts

Sara Kuruvilla, MD

(519)685-8500sara@kuruvilla@lhsc.on.ca

Locations

Juravinski Cancer Centre

Recruiting

Hamilton, Ontario, Canada, L8N 3Z5

Contacts

Brandon Meyers, MD

905-521-2100meyersbr@hhsc.ca

Sunnybrook Health Sciences Centre

Recruiting

Toronto, Ontario, Canada, M4N 3M5

Contacts

Martin Smoragiewicz, MD

416-480-4617martin.smoragiewicz@sunnybrook.ca

More Information

Sponsor

London Health Sciences Centre Research Institute OR Lawson Research Institute of St. Joseph's

Last update posted

Jul 31, 2025

Last verified

Jul, 2025

Trial information was received from ClinicalTrials.gov and was last updated on 2026-09-10. This information was provided to ClinicalTrials.gov by London Health Sciences Centre Research Institute OR Lawson Research Institute of St. Joseph's on 2025-07-31.