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Alkylating agents

Low vs High-Dose Cisplatin with Radiotherapy for Head and Neck Cancer (RADIO Trial)

N/A
Recruiting
Led By Sara Kuruvilla, MD
Research Sponsored by Lawson Health Research Institute
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial
Must have
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
Age 18 or older
Timeline
Screening 3 weeks
Treatment Varies
Follow Up captured annually starting at a year post start of treatment and continued for up to 5 years following start of treatment.
Awards & highlights

RADIO Trial 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.

Who is the study for?
Adults with certain head and neck cancers, including oral squamous cell carcinoma, who are fit for high-dose cisplatin therapy. They must have good organ function, no severe hearing loss or neuropathy, not be pregnant or breastfeeding, able to attend treatments and follow-ups, and willing to use contraception.Check my eligibility
What is being tested?
The trial is testing two different doses of Cisplatin given alongside radiotherapy in patients with head and neck cancers. Participants will be randomly assigned to receive either a high dose once every three weeks (HD) or a low dose weekly (LD).See study design
What are the potential side effects?
Cisplatin can cause side effects like nausea, vomiting, kidney damage, hearing loss, nerve problems such as numbness or tingling in the hands and feet (neuropathy), blood disorders like anemia or low white blood cells which can increase infection risk.

RADIO Trial Eligibility Criteria

Inclusion Criteria

You may be eligible if you check “Yes” for the criteria below
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My blood counts and organ functions are within the required ranges.
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I am 18 years old or older.
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My cancer is confirmed as squamous cell carcinoma.
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I have been evaluated by a team of head and neck cancer specialists.
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My cancer originates in the mouth, throat, nasal cavity, or related glands.
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I can take care of myself and am up and about more than half of my waking hours.

RADIO Trial Timeline

Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~captured annually starting at a year post start of treatment and continued for up to 5 years following start of treatment.
This trial's timeline: 3 weeks for screening, Varies for treatment, and captured annually starting at a year post start of treatment and continued for up to 5 years following start of treatment. for reporting.

Treatment Details

Study Objectives

Outcome measures can provide a clearer picture of what you can expect from a treatment.
Primary outcome measures
Compare Incidence of > Grade 1 hearing loss
Compare Incidence of > Grade 2 hearing loss
Hearing related quality of life (QOL)
Secondary outcome measures
Change in Health related Quality of Life (HRQOL)
Change in neuropathy-associated QOL
Compare incidence of > grade 2 hearing loss
+6 more
Other outcome measures
Cost-effectiveness analysis
Locoregional control
Overall Survival
+2 more

RADIO Trial Design

2Treatment groups
Active Control
Group I: ARM 1: High-Dose Cisplatin days 1, 22 & 43 with radiotherapyActive Control2 Interventions
Group II: ARM 2: Low-Dose Cisplatin Q 1 wk + radiotherapyActive Control2 Interventions

Find a Location

Who is running the clinical trial?

Lawson Health Research InstituteLead Sponsor
659 Previous Clinical Trials
413,632 Total Patients Enrolled
Sara Kuruvilla, MDPrincipal InvestigatorLondon Health Sciences Centre, London Regional Cancer Program
1 Previous Clinical Trials
25,000 Total Patients Enrolled

Media Library

High-Dose Cisplatin (Alkylating agents) Clinical Trial Eligibility Overview. Trial Name: NCT03649048 — N/A
Head and Neck Cancers Research Study Groups: ARM 1: High-Dose Cisplatin days 1, 22 & 43 with radiotherapy, ARM 2: Low-Dose Cisplatin Q 1 wk + radiotherapy
Head and Neck Cancers Clinical Trial 2023: High-Dose Cisplatin Highlights & Side Effects. Trial Name: NCT03649048 — N/A
High-Dose Cisplatin (Alkylating agents) 2023 Treatment Timeline for Medical Study. Trial Name: NCT03649048 — N/A

Frequently Asked Questions

These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.

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."

Answered by AI

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."

Answered by AI

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."

Answered by AI

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."

Answered by AI

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."

Answered by AI
Recent research and studies
clinicaltrials.govStudy
Low-Dose Weekly vs High-Dose Cisplatin
2018. "Low-Dose Weekly vs High-Dose Cisplatin". ClinicalTrials.gov. https://clinicaltrials.gov/ct2/show/NCT03649048.
~44 spots leftby Sep 2028
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