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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.

Must not have

- Pregnancy and individuals unwilling to discontinue nursing

- Other chronic renal disease like nephrotic syndrome, that could be worsened by cisplatin therapy

Timeline

Screening 3 weeks

Treatment Varies

Follow Up up to 9 years

Awards & highlights

No Placebo-Only Group

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.

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.

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.

Exclusion Criteria

You may be eligible for the trial if you check “No” for criteria below:

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I am not pregnant or nursing, or I am willing to stop nursing.

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I have a kidney condition that could worsen with cisplatin therapy.

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My cancer has come back after treatment.

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I do not have an infection that needs IV antibiotics right now.

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I have cancer in my mouth, nasopharynx, or a p16-negative unknown primary cancer.

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My cancer has spread to distant parts of my body.

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I've had radiation in the same area where my current cancer is located.

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I haven't been hospitalized for unstable angina in the last 6 months.

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I have not had a heart attack in the last 6 months.

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I have severe, unfixable electrolyte issues despite treatment.

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I do not have severe numbness or pain in my hands or feet.

Timeline

Screening ~ 3 weeks3 visits

Treatment ~ Varies

Follow Up ~ up to 9 years

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

Study objectives can provide a clearer picture of what you can expect from a treatment.

Primary study objectives

Incidence of acute toxicity (Phase II)

Incidence of acute toxicity (Phase III)

Overall Survival (OS) (Phase III)

Secondary study objectives

Hearing loss

Incidence of acute toxicity

Incidence of late toxicity

+1 more

Awards & Highlights

No Placebo-Only Group

All patients enrolled in this study will receive some form of active treatment.

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

~3120

Radiation Therapy

2017

Completed Phase 3

~7250