What side effects are associated with this type of intervention?

The most common treatments for Head and Neck Squamous Cell Carcinoma (HNSCC) include cisplatin-based chemotherapy, often combined with radiation therapy (RT). Known side effects of cisplatin include pharyngeal mucositis, severe acute and late toxicities, hypomagnesemia, severe skin reactions, and sepsis. Cisplatin can also cause nausea, vomiting, nephrotoxicity, and ototoxicity. When combined with RT, the toxicity profile can worsen, leading to increased severity of these side effects.

What prior FDA approvals exist?

The FDA has approved several treatments for Head and Neck Squamous Cell Carcinoma (HNSCC) that are similar to those being studied in the trial involving cisplatin. Cisplatin itself is a widely used chemotherapy drug that kills tumor cells, stops them from dividing, or prevents them from spreading. Cetuximab, an EGFR-targeting monoclonal antibody, has been approved for use in combination with radiation therapy and as a single agent in metastatic settings. Additionally, PD-1 inhibitors such as nivolumab and pembrolizumab have been approved for patients with HNSCC who have previously been treated with platinum-based chemotherapy, offering another line of treatment for recurrent or metastatic disease.

What other types of research exist?

Promising novel alternatives to Cisplatin for HNSCC patients include: 1) Pembrolizumab, an immunotherapy agent, either alone or in combination with chemotherapy or cetuximab. 2) Nivolumab, another immunotherapy option, which has shown benefits in recurrent or metastatic cases. 3) Metronomic chemotherapy, which uses frequent, lower doses of chemotherapy to target tumor angiogenesis and minimize toxicity. 4) Small molecule tyrosine kinase inhibitors like afatinib and gefitinib, although their clinical roles are still being established. 5) Farnesyltransferase inhibitors, such as tipifarnib, which have shown promising response rates in HRAS mutant HNSCC.

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Radiation Therapy + Cisplatin for Head and Neck Cancer

Phase 2

Recruiting

Led By Robert Ferris

Research Sponsored by ECOG-ACRIN Cancer Research Group

Eligibility Criteria Checklist

Specific guidelines that determine who can or cannot participate in a clinical trial

Must have

Pathologically proven diagnosis of squamous cell carcinoma of the head/neck (oral cavity, oropharynx, hypopharynx or larynx) at stage III or IVA

Patients with a history of a curatively treated malignancy must be disease-free for at least two years except for carcinoma in situ of cervix and/or non-melanomatous skin cancer

Timeline

Screening 3 weeks

Treatment Varies

Follow Up date of randomization to the date of recurrence, second primary tumor from the head and neck region, or death, assessed up to 10 years

Awards & highlights

No Placebo-Only Group

Summary

This trial is studying if using a specific type of energy treatment alone or with a drug is better for treating patients with advanced head and neck cancer after surgery. The energy treatment kills cancer cells, and the drug helps by stopping their growth or killing them. The drug has been used for many years in the treatment of advanced cancers, including head and neck cancers, and is known for its ability to enhance the effects of the energy treatment.

Who is the study for?

This trial is for adults with stage III-IVA squamous cell carcinoma of the head and neck who've had surgery. They should not have recurrent disease or multiple cancers, must be two years free from other cured cancers (except certain skin/cervix cancers), and can't have had prior radiation in the same area. Participants need proper kidney function, blood counts within normal ranges, no pregnancy or breastfeeding, and they must use contraception.

What is being tested?

The study is examining if adding cisplatin to radiation therapy improves outcomes for patients post-surgery compared to radiation alone. It's a phase II trial where participants are randomly assigned to receive either both treatments or just radiation therapy.

What are the potential side effects?

Radiation may cause skin irritation, fatigue, dry mouth/throat issues while cisplatin can lead to nausea, kidney problems, hearing changes and nerve damage. Side effects vary by individual.

Eligibility Criteria

Inclusion Criteria

You may be eligible if you check “Yes” for the criteria below

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My cancer is a type of squamous cell carcinoma in the head or neck, at stage III or IVA.

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I've been cancer-free for 2 years, except for certain skin cancers or cervical pre-cancer.

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My cancer has not come back or spread from its original site.

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My white blood cell count is healthy.

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I had surgery to completely remove my cancer with the goal of curing it.

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My oropharynx tumor is not caused by HPV.

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I haven't had radiation to my head or neck that would affect my current treatment area.

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I can send a tissue sample from my surgery to Foundation Medicine.

Timeline

Screening ~ 3 weeks3 visits

Treatment ~ Varies

Follow Up ~ date of randomization to the date of recurrence, second primary tumor from the head and neck region, or death, assessed up to 10 years

Screening ~ 3 weeks

Treatment ~ Varies

Follow Up ~date of randomization to the date of recurrence, second primary tumor from the head and neck region, or death, assessed up to 10 years

This trial's timeline: 3 weeks for screening, Varies for treatment, and date of randomization to the date of recurrence, second primary tumor from the head and neck region, or death, assessed up to 10 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

Disease-free survival in patients with stage III-IV disease and disruptive p53 mutation

Secondary study objectives

Disease-free survival in patients with stage III-IV disease and non-disruptive p53 mutation

Disease-free survival in patients with stage III-IV disease and wild type p53 mutation

Incidence of adverse events graded using Common Terminology Criteria for Adverse Events version 4

+1 more

Awards & Highlights

No Placebo-Only Group

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

Trial Design

2Treatment groups

Experimental Treatment

Group I: Arm B (IMRT, cisplatin)Experimental Treatment3 Interventions

Patients undergo IMRT QD 5 days a week and receive cisplatin IV over 1-2 hours weekly for 6 weeks in the absence of disease progression or unacceptable toxicity.

Group II: Arm A (IMRT)Experimental Treatment2 Interventions

Patients undergo IMRT QD 5 days a week for 6 weeks 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

Intensity-Modulated Radiation Therapy

2010

Completed Phase 3

~2160

0 / 8Eligibility criteria met

Research Highlights

Information in this section is not a recommendation. We encourage patients to speak with their healthcare team when evaluating any treatment decision.

Mechanism Of Action

Side Effect Profile

Prior Approvals

Other Research

The most common treatments for Head and Neck Squamous Cell Carcinoma (HNSCC) include chemotherapy, radiation therapy, and targeted therapies. Cisplatin, a widely used chemotherapy drug, kills tumor cells, stops them from dividing, and prevents them from spreading. Radiation therapy employs high-energy x-rays to destroy tumor cells and reduce tumor size. Targeted therapies, such as cetuximab, specifically inhibit molecules that drive tumor growth and progression. These treatments are vital for HNSCC patients as they aim to control the aggressive nature of the cancer, reduce tumor burden, prevent metastasis, and ultimately improve patient survival outcomes.