Low-Dose Weekly vs High-Dose Cisplatin

NCT03649048 | Recruiting DMC

• 1 other identifier: Cisplatin HD vs LD
• Study Type: interventional
• Target: 100
• Locations: 1 country
• Sites: 3

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

Outcome Measures

Primary Outcomes (4)

• Hearing related quality of life (QOL)

  Assessed with the Hearing Handicap Inventory for Adults (HHIA) Questionnaires. Scored by a points system. The higher the points the more significant the hearing handicap.

  1-year post start of treatment

• Hearing related quality of life (QOL)

  Assessed with the Hearing Handicap Inventory for the Elderly (HHIE). Scored by a points system. The higher the points the more significant the hearing handicap.

  1-year post start of treatment

• Compare Incidence of > Grade 2 hearing loss

  A comprehensive audiological examination including case history, otoscopy, behavioural and physiological auditory measures will be conducted prior to an ototoxic drug administration. Subsequent audiology testing will be performed at 3, 6 and 12 months post-start of treatment.

  At 1 year post start of treatment

• Compare Incidence of > Grade 1 hearing loss

  Will be scored according to the CTCAE v4.02 (Common Terminology Criteria for Adverse Events)

  At 1 year post start of treatment

Secondary Outcomes (10)

• Proportion of patients recommended for hearing amplification

  at year 1 post start of treatment

• Compare incidence of > grade 2 hearing loss

  At 6 months and at 1 year post start of treatment

• Change in Health related Quality of Life (HRQOL)

  At 1 year post start of treatment

• Incidence of > Grade 3 treatment-related neuropathy

  At baseline, day 21 and day 42

• Change in neuropathy-associated QOL

  At year 1 post start of treatment

Other Outcomes (5)

• Overall Survival

  Captured annually starting at a year post start of treatment and continued for up to 5 years following date of randomization.

• Progression-free Survival

  Captured annually starting at a year post start of treatment and continued for up to 5 years following date of randomization.

• Locoregional control

  Captured annually starting at a year post start of treatment and continued for up to 5 years following start of treatment.

Study Arms (2)

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

ACTIVE COMPARATOR

Drug: High-Dose Cisplatin; Radiation: Radiotherapy

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

ACTIVE COMPARATOR

Drug: Low-Dose Cisplatin; Radiation: Radiotherapy

Interventions

High-Dose Cisplatin DRUG

Intravenous administration of High-Dose Cisplatin

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

Low-Dose Cisplatin DRUG

Intravenous administration of Low-Dose Cisplatin

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

Radiotherapy RADIATION

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

ARM 1: High-Dose Cisplatin days 1, 22 & 43 with radiotherapy; ARM 2: Low-Dose Cisplatin Q 1 wk + radiotherapy

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify 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
• 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.

You may not qualify 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.
• 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.

Sponsors & Collaborators

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

Study Sites (3)

Juravinski Cancer Centre

Hamilton, Ontario, L8N 3Z5, Canada

RECRUITING

London Regional Cancer Program

London, Ontario, N6A 5W9, Canada

ACTIVE NOT RECRUITING

Sunnybrook Health Sciences Centre

Toronto, Ontario, M4N 3M5, Canada

RECRUITING

MeSH Terms

Interventions

Cisplatin; Radiotherapy

Intervention Hierarchy (Ancestors)

Chlorine Compounds; Inorganic Chemicals; Nitrogen Compounds; Platinum Compounds; Therapeutics

Study Officials

• Sara Kuruvilla, MD

  London Health Sciences Centre, London Regional Cancer Program

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Sara Kuruvilla, MD

CONTACT

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

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: SUPPORTIVE CARE
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: June 29, 2018
• First Posted: August 28, 2018
• Study Start: November 5, 2018
• Primary Completion (Estimated): September 1, 2028
• Study Completion (Estimated): September 1, 2028
• Last Updated: July 31, 2025

Record last verified: 2025-07

Locations

CA (3)