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Chemotherapy

Chemoradiotherapy for Head and Neck Cancer

Phase 2

Waitlist Available

Led By Patrick D. Maguire, M.D.

Research Sponsored by Coastal Carolina Radiation Oncology

Eligibility Criteria Checklist

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

Must have

ECOG performance status 0-1

No prior radiotherapy to the head and neck region

Timeline

Screening 3 weeks

Treatment Varies

Follow Up 4 years

Awards & highlights

Study Summary

This trial is testing a new way to give chemotherapy and radiation therapy to people with head and neck squamous cell carcinoma. The new way is less toxic and has a better quality of life than the old way.

Who is the study for?

Adults over 18 with certain stages of squamous cell carcinoma in the oral cavity, oropharynx, hypopharynx, or larynx can join. They shouldn't have had surgery for it yet (except lymph node biopsy), no prior chemo or radiotherapy to the head and neck, and must be generally healthy with good organ function. Pregnant women and those with other recent cancers or heart issues can't participate.Check my eligibility

What is being tested?

The trial is testing a combination of chemotherapy and radiation therapy specifically designed to treat advanced head and neck cancer while trying to reduce side effects and improve quality of life. It builds on previous research that used IMRT (a type of targeted radiation) along with weekly cisplatin (a chemotherapy drug).See study design

What are the potential side effects?

Possible side effects include reactions related to cisplatin like nausea, kidney problems, hearing changes; as well as general effects from radiation such as skin irritation, fatigue, dry mouth/throat issues depending on the area treated.

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 can carry out light work.

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I have not had radiation therapy to my head or neck.

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I haven't had surgery to remove my cancer or lymph nodes, except for a biopsy.

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My cancer is a type of squamous cell carcinoma located in my mouth or throat.

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I am older than 18 years.

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My tumor was tested for HPV and checked for p16.

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I have never received cisplatin chemotherapy.

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I haven't had a heart attack or heart disease symptoms in the last 6 months.

Timeline

Screening ~ 3 weeks3 visits

Treatment ~ Varies

Follow Up ~ 4 years

Screening ~ 3 weeks

Treatment ~ Varies

Follow Up ~4 years

This trial's timeline: 3 weeks for screening, Varies for treatment, and 4 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

To assess the actuarial elective nodal failure (ENF) rate for patients with locally advanced HNSCC treated with chemoRT including very low dose elective nodal IMRT and concurrent weekly cisplatin.

Secondary outcome measures

To assess actuarial LRC, DFS, and OS rates.

To evaluate grade 3-5 toxicity by CTCAE v4.0, with special attention to swallowing function, feeding tube dependence, and xerostomia.

To evaluate patients' quality of life (QOL).

0 / 8Eligibility criteria met

Find a Location

Who is running the clinical trial?

Coastal Carolina Radiation OncologyLead Sponsor

1 Previous Clinical Trials

84 Total Patients Enrolled

National Cancer Institute (NCI)NIH

13,657 Previous Clinical Trials

40,933,591 Total Patients Enrolled

New Hanover Regional Medical CenterOTHER

6 Previous Clinical Trials

906 Total Patients Enrolled

Media Library

Cisplatin (Chemotherapy) Clinical Trial Eligibility Overview. Trial Name: NCT01372111 — Phase 2

Head and Neck Cancers Research Study Groups:

Head and Neck Cancers Clinical Trial 2023: Cisplatin Highlights & Side Effects. Trial Name: NCT01372111 — Phase 2

Cisplatin (Chemotherapy) 2023 Treatment Timeline for Medical Study. Trial Name: NCT01372111 — Phase 2

Frequently Asked Questions

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

Is this medical treatment safe for those receiving it?

"Our assessment concluded that this treatment is safe to use, garnering a score of 2 on the scale. This can be attributed to Phase 2 data available which indicates its safety but not necessarily effectiveness."

Answered by AI

Is there room for additional participants in this research endeavor?

"Contrary to what is listed on clinicaltrials.gov, this medical research endeavour is no longer accepting new participants. First appearing in March of 2011 and last updated in December 2015, there are now 481 other studies actively searching for patients."

Answered by AI

In which locations is this clinical study available?

"This experiment is currently onboarding participants at 5 clinics, located in New Bern, Supply and Morehead City as well as two other places. To minimise travel obligations if you join the trial it would be beneficial to pick a site close by."

Answered by AI

Recent research and studies

International Journal of Radiation Oncology*Biology*PhysicsJournal

Phase II Trial of Hyperfractionated Intensity-modulated Radiation Therapy and Concurrent Weekly Cisplatin for Stage III and Iva Head-and-neck Cancer

Maguire, Patrick D., Michael Papagikos, Sue Hamann, Charles Neal, Martin Meyerson, Neil Hayes, Peter Ungaro, et al.. 2011. “Phase II Trial of Hyperfractionated Intensity-modulated Radiation Therapy and Concurrent Weekly Cisplatin for Stage III and Iva Head-and-neck Cancer”. International Journal of Radiation Oncology*biology*physics. Elsevier BV. doi:10.1016/j.ijrobp.2009.12.046.

clinicaltrials.govStudy

Chemoradiotherapy With Elective Low Dose Nodal Radiation for Locally Advanced Head and Neck Cancer

2011. "Chemoradiotherapy With Elective Low Dose Nodal Radiation for Locally Advanced Head and Neck Cancer". ClinicalTrials.gov. https://clinicaltrials.gov/ct2/show/NCT01372111.

All > Head And Neck Cancer