Low-Dose Weekly vs High-Dose Cisplatin

ConditionLocally Advanced Head and Neck Squamous Cell Carcinoma

Trial statusRecruiting

Trial phaseNot applicable

Trial typeInterventional

Biological sexAll

Age18+

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

About this trial

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.

Eligibility criteria

This trial does not accept healthy volunteers

Qualifiers

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

Disqualifiers

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.

Trial design

Design model

Parallel

Treatments tested in this trial

High-Dose Cisplatin
Drug
Intravenous administration of High-Dose Cisplatin
Low-Dose Cisplatin
Drug
Intravenous administration of Low-Dose Cisplatin
Radiotherapy
Radiation
Participating centres are to follow their local radiation treatment planning and delivery techniques.

Treatment groups

100 Participants

are divided into 2 treatment groups

Group A: ARM 1: High-Dose Cisplatin days 1, 22 & 43 with radiotherapyActive comparator 2 interventions

Group B: ARM 2: Low-Dose Cisplatin Q 1 wk + radiotherapyActive comparator 2 interventions

Trial outcomes

Primary outcomes

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.

Time frame

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.

Time frame

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.

Time frame

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)

Time frame

At 1 year post start of treatment

Secondary outcomes

Proportion of patients recommended for hearing amplification

This information will be specified on the audiology report and collected on the CRF

Time frame

at year 1 post start of treatment

Compare incidence of > grade 2 hearing loss

This information will be specified on the audiology report and collected on the CRF

Time frame

At 6 months and at 1 year post start of treatment

Change in Health related Quality of Life (HRQOL)

Measured using the EORTC (European Organisation for Research and Treatment of Cancer) QLQ H\&N35 (Quality of Life Questionnaire Head \& Neck). According to the EORTC scoring guidelines All of the scales and single-item measures range in score from 0 to 100. A high scale score represents a higher response level. Thus a high score for a functional scale represents a high / healthy level of functioning, a high score for the global health status / QoL represents a high QoL, but a high score for a symptom scale / item represents a high level of symptomatology / problems.

Time frame

At 1 year post start of treatment

Incidence of > Grade 3 treatment-related neuropathy

Measured using the CTCAE Version 4.02 (Common Terminology Criteria for Adverse Events)

Time frame

At baseline, day 21 and day 42

Other outcomes

Overall Survival

Defined as time from randomization to death from any cause

Time frame

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

Progression-free Survival

Defined as time from randomization to disease progression at any site or death.

Time frame

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

Locoregional control

Defined as local if within the zone of the primary tumour, and as regional if occurring elsewhere including neck lymph nodes.

Time frame

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

Cost-effectiveness analysis

Using the EQ-5D-5L questionnaire(EuroQol 5 level questionnaire). The EQ-5D-5L descriptive system comprises five dimensions: mobility, self-care, usual activities, pain/discomfort and anxiety/depression. Each dimension has 5 levels: no problems, slight problems, moderate problems, severe problems and extreme problems. Patient is asked to indicate their health by ticking the box next to the most appropriate statement in each of the five dimensions. This decision results in a 1-digit number that expresses the level selected for that dimension. The digits for the five dimensions can be combined into a 5-digit number that describes the patient's health state.

Time frame

At 1 year post start of treatment

Sponsors and contacts

Click on the lead sponsor to view all of their trials.

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

Lead sponsor

Source ClinicalTrials.gov

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