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Alkylating agents

High-Dose vs Low-Dose Cisplatin with Radiation for Head and Neck Cancer

Phase 2 & 3
Recruiting
Led By Paul M Harari
Research Sponsored by NRG Oncology
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial
Must have
Zubrod (Eastern Cooperative Oncology Group [ECOG]) performance status of 0-1 within 14 days prior to registration
-- Fludeoxyglucose F-18 (FDG)-positron emission tomography (PET)/CT of the neck; the CT component must be of diagnostic quality with contrast, unless contraindicated.
Timeline
Screening 3 weeks
Treatment Varies
Follow Up up to 9 years
Awards & highlights

Study Summary

This trial is testing whether a lower dose of a chemotherapy drug, given more often, is as effective as a higher dose of the drug given less often, in treating patients with head and neck cancer.

Who is the study for?
Adults with advanced head and neck cancer, including oral, laryngeal, oropharyngeal cancers but not oral cavity or nasopharynx cancers. Participants must have measurable disease, no history of cisplatin treatment for the current cancer, no distant metastases, and organ function within certain limits. HIV-positive patients are eligible if well-controlled. Pregnant or nursing individuals are excluded.Check my eligibility
What is being tested?
The trial is comparing two dosing schedules of cisplatin chemotherapy combined with radiation therapy to treat locoregionally advanced head and neck cancer: high-dose every three weeks versus low-dose weekly. The goal is to determine which regimen offers better outcomes.See study design
What are the potential side effects?
Cisplatin can cause side effects like nausea, vomiting, kidney damage, hearing loss (ototoxicity), nerve damage (neuropathy), blood cell count changes leading to increased infection risk or bleeding problems. Radiation may cause skin irritation at the treatment site and fatigue.

Eligibility Criteria

Inclusion Criteria

You may be eligible if you check “Yes” for the criteria below
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I am fully active or restricted in physically strenuous activity but can do light work.
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I have had a PET/CT scan of my neck with contrast.
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My throat cancer is p16-negative and matches specific stage criteria.
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I am not pregnant and have not had menopause or been sterilized.
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I have had a CT scan of my neck with contrast, unless it was not suitable for me.
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My cancer's origin is unknown, I may or may not smoke, and it has spread to nearby lymph nodes.
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My kidney function, measured by creatinine clearance, is good.
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I have had a recent high-quality scan of my neck.
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My cancer is in the oropharynx, I've smoked 10 or fewer pack-years, and my cancer stage fits specific criteria.
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My cancer shows high levels of p16 according to my pathology report.
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My cancer has not spread to distant parts of my body according to the latest tests.
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My cancer is in the oropharynx, I've smoked more than 10 pack-years, and my cancer stage fits specific criteria.
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I am 18 years old or older.
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I have had an MRI of the neck with contrast, unless it was not recommended for me.
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My cancer is in the larynx/hypopharynx and matches specific stage criteria.

Timeline

Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~up to 9 years
This trial's timeline: 3 weeks for screening, Varies for treatment, and up to 9 years for reporting.

Treatment Details

Study Objectives

Outcome measures can provide a clearer picture of what you can expect from a treatment.
Primary outcome measures
Incidence of acute toxicity (Phase II)
Incidence of acute toxicity (Phase III)
Overall Survival (OS) (Phase III)
Secondary outcome measures
Hearing loss
Incidence of acute toxicity
Incidence of late toxicity
+2 more

Trial Design

4Treatment groups
Experimental Treatment
Group I: Arm IV (low-dose cisplatin, radiation therapy)Experimental Treatment4 Interventions
p16-POSITIVE OPC/CUP: Patients undergo radiation therapy over 5 fractions a week for a total of 33-35 fractions in the absence of disease progression or unacceptable toxicity. Patients also receive low-dose cisplatin IV QW during radiation therapy in the absence of disease progression or unacceptable toxicity.
Group II: Arm III (high-dose cisplatin, radiation therapy)Experimental Treatment4 Interventions
p16-POSITIVE OPC/CUP: Patients undergo radiation therapy over 5 fractions a week for a total of 33-35 fractions in the absence of disease progression or unacceptable toxicity. Patients also receive high-dose cisplatin IV Q3W (on days 1, 22, and 43) during radiation therapy in the absence of disease progression or unacceptable toxicity.
Group III: Arm II (low-dose cisplatin, radiation therapy)Experimental Treatment4 Interventions
NON-OPC/p16-NEGATIVE OPC: Patients undergo radiation therapy over 5 fractions a week for a total of 33-35 fractions in the absence of disease progression or unacceptable toxicity. Patients also receive low-dose cisplatin IV QW during radiation therapy in the absence of disease progression or unacceptable toxicity.
Group IV: ARM I (high-dose cisplatin, radiation therapy)Experimental Treatment4 Interventions
NON-OPC/p16-NEGATIVE OPC: Patients undergo radiation therapy over 5 fractions a week for a total of 33-35 fractions in the absence of disease progression or unacceptable toxicity. Patients also receive high-dose cisplatin IV Q3W (on days 1, 22, and 43) during radiation therapy in the absence of disease progression or unacceptable toxicity.
Treatment
First Studied
Drug Approval Stage
How many patients have taken this drug
Cisplatin
2013
Completed Phase 3
~1940
Radiation Therapy
2017
Completed Phase 3
~7250

Find a Location

Who is running the clinical trial?

NRG OncologyLead Sponsor
231 Previous Clinical Trials
100,388 Total Patients Enrolled
National Cancer Institute (NCI)NIH
13,664 Previous Clinical Trials
40,925,669 Total Patients Enrolled
Paul M HarariPrincipal InvestigatorNRG Oncology
1 Previous Clinical Trials
613 Total Patients Enrolled

Media Library

Cisplatin (Alkylating agents) Clinical Trial Eligibility Overview. Trial Name: NCT05050162 — Phase 2 & 3
Head and Neck Cancers Research Study Groups: ARM I (high-dose cisplatin, radiation therapy), Arm II (low-dose cisplatin, radiation therapy), Arm III (high-dose cisplatin, radiation therapy), Arm IV (low-dose cisplatin, radiation therapy)
Head and Neck Cancers Clinical Trial 2023: Cisplatin Highlights & Side Effects. Trial Name: NCT05050162 — Phase 2 & 3
Cisplatin (Alkylating agents) 2023 Treatment Timeline for Medical Study. Trial Name: NCT05050162 — Phase 2 & 3

Frequently Asked Questions

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

How many patients are being treated with this new medication?

"464 volunteers that meet the pre-determined eligibility requirements are necessary to enroll in this study. The trial is being conducted at Parkland Health Center - Farmington in Farmington, Missouri and IHA Hematology Oncology Consultants-Ann Arbor in Ypsilanti, Michigan."

Answered by AI

Is this clinical trial being run in multiple locations throughout Canada?

"One hundred different medical facilities are participating in this clinical trial, with locations in Farmington, Ypsilanti, Cape Girardeau, and many other cities. If you enroll, try to pick a centre near you to limit travel."

Answered by AI

Are people with the required medical conditions still being accepted into this trial period?

"The information on clinicaltrials.gov indicates that this trial is currently recruiting participants. The trial was originally posted on October 27, 2021 and was last updated on August 12, 2022."

Answered by AI

What is the main purpose of Quality-of-Life Assessment?

"Quality-of-Life Assessment is a standard neoplasm metastasis treatment, but can also be useful in managing advanced ovarian cancer, refractory conditions, and advance directives."

Answered by AI

Is this the first research project to focus on Quality-of-Life Assessment?

"The first Quality-of-Life Assessment study was completed in 1997 at City of Hope Comprehensive Cancer Center. There have been a total of 1277 such studies completed to date. There are presently 773 clinical trials actively recruiting, a majority of which are based in Farmington, Missouri."

Answered by AI

Who else is applying?

What state do they live in?
Louisiana
How old are they?
18 - 65
What site did they apply to?
Louisiana State University Health Science Center
What portion of applicants met pre-screening criteria?
Met criteria
Recent research and studies
clinicaltrials.govStudy
Comparing High-Dose Cisplatin Every Three Weeks to Low-Dose Cisplatin Weekly When Combined With Radiation for Patients With Advanced Head and Neck Cancer
2021. "Comparing High-Dose Cisplatin Every Three Weeks to Low-Dose Cisplatin Weekly When Combined With Radiation for Patients With Advanced Head and Neck Cancer". ClinicalTrials.gov. https://clinicaltrials.gov/ct2/show/NCT05050162.
~309 spots leftby Feb 2031
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