ARM 1: High-Dose Cisplatin days 1, 22 & 43 with radiotherapy for Head and Neck Cancer

Phase-Based Progress Estimates
1
Effectiveness
1
Safety
Juravinski Cancer Centre, Hamilton, CanadaHead and Neck CancerHigh-Dose Cisplatin - Drug
Eligibility
18+
All Sexes
What conditions do you have?
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Study Summary

This trial is testing whether a high or low dose of cisplatin given with radiation therapy is better for treating a certain type of cancer.

Eligible Conditions
  • Head and Neck Cancer

Treatment Effectiveness

Study Objectives

3 Primary · 9 Secondary · Reporting Duration: Captured annually starting at a year post start of treatment and continued for up to 5 years following start of treatment.

1-year post start of treatment
Hearing related quality of life (QOL)
Day 42
Incidence of any treatment related nephropathy
Year 1
Change in Health related Quality of Life (HRQOL)
Compare Incidence of > Grade 1 hearing loss
Compare Incidence of > Grade 2 hearing loss
Cost-effectiveness analysis
Prevalence of persistent > Grade 3 nephropathy
Year 1
Radiation doses to the cochlea
Year 1
Compare incidence of > grade 2 hearing loss
At baseline
Evaluate the validity of COMT SNPs as a predictor of ototoxicity
Evaluate the validity of MATE1 SNPs as a predictor of ototoxicity
Day 42
Incidence of > Grade 3 treatment-related neuropathy
Year 1
Change in neuropathy-associated QOL
Year 5
Overall Survival
Progression-free Survival
Year 5
Locoregional control
Year 1
Proportion of patients recommended for hearing amplification

Trial Safety

Trial Design

2 Treatment Groups

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

Active Control

100 Total Participants · 2 Treatment Groups

Primary Treatment: ARM 1: High-Dose Cisplatin days 1, 22 & 43 with radiotherapy · No Placebo Group · N/A

ARM 1: High-Dose Cisplatin days 1, 22 & 43 with radiotherapyActiveComparator Group · 2 Interventions: High-Dose Cisplatin, Radiotherapy · Intervention Types: Drug, Radiation
ARM 2: Low-Dose Cisplatin Q 1 wk + radiotherapyActiveComparator Group · 2 Interventions: Low-Dose Cisplatin, Radiotherapy · Intervention Types: Drug, Radiation

Trial Logistics

Trial Timeline

Screening: ~3 weeks
Treatment: Varies
Reporting: captured annually starting at a year post start of treatment and continued for up to 5 years following start of treatment.

Who is running the clinical trial?

Lawson Health Research InstituteLead Sponsor
620 Previous Clinical Trials
403,154 Total Patients Enrolled
6 Trials studying Head and Neck Cancer
344 Patients Enrolled for Head and Neck Cancer
Sara Kuruvilla, MDPrincipal InvestigatorLondon Health Sciences Centre, London Regional Cancer Program
1 Previous Clinical Trials
25,000 Total Patients Enrolled

Eligibility Criteria

Age 18+ · All Participants · 11 Total Inclusion Criteria

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Frequently Asked Questions

What objectives is this clinical research endeavor seeking to fulfill?

"The primary endpoint of this investigation over a 1-year time frame evaluates the prevalence of Grade 2 hearing loss. Secondary metrics being monitored include incidence of > grade 2 hearing loss, proportion of patients recommended for amplification and variations in Health related Quality Of Life (HRQOL) assessed using the EORTC QLQ-30 scale with scores ranging from 0 to 100 wherein higher values reflect increased response levels or quality of life." - Anonymous Online Contributor

Unverified Answer

How many participants are currently being accepted into this clinical experiment?

"Affirmative. Clinicaltrials.gov data affirms that this medical test, posted on November 5th 2018, is actively looking for participants. A total of 100 individuals are required from 3 separate research centres." - Anonymous Online Contributor

Unverified Answer

What is the objective of administering high-dose cisplatin on days 1, 22 & 43 in combination with radiotherapy?

"ARM 1: High-Dose Cisplatin administered on days 1, 22 & 43 combined with radiotherapy is a viable option for patients suffering from advanced ovarian cancer, advanced testicular cancer, and those who are unresponsive to traditional therapies." - Anonymous Online Contributor

Unverified Answer

Is there a current call for participants in this examination?

"Affirmative. Clinicaltrials.gov indicates that this clinical trial is actively recruiting, commencing on the 5th of November 2018 and last updated on the 7th of June 2022. The objective is to enrol 100 patients from 3 distinct medical facilities." - Anonymous Online Contributor

Unverified Answer

Has prior research indicated the efficacy of administering high-dose cisplatin on days 1, 22 and 43 in combination with radiotherapy for ARM 1?

"At present, 688 clinical trials examining ARM 1: High-Dose Cisplatin days 1, 22 & 43 with radiotherapy are taking place. Of these studies, 274 have reached the Phase 3 stage of their investigation. Shanghai is a major hub for such research; nonetheless, there are over forty thousand sites conducting tests related to this protocol worldwide." - Anonymous Online Contributor

Unverified Answer
Please Note: These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.