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Monoclonal Antibodies

Chemotherapy + Radiation Therapy for Head and Neck Cancer

Phase 2 & 3
Recruiting
Led By Paul M Harari
Research Sponsored by National Cancer Institute (NCI)
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial
Must have
Pathologic stage III or IV HNSCC, no distant metastases, based on minimum diagnostic workup
Pre-operative Imaging of the head and neck within 84 days prior to surgery
Timeline
Screening 3 weeks
Treatment Varies
Follow Up from date of randomization to death due to any cause, assessed up to 7 years
Awards & highlights
No Placebo-Only Group

Study Summary

This trial is testing how well radiation therapy works in combination with different drugs after surgery to treat patients with high-risk stage III-IV head and neck cancer.

Who is the study for?
This trial is for adults with high-risk head and neck cancer who've had surgery to remove it. They should have no other cancers for the past 3 years, not be pregnant, and agree to birth control if needed. Key eligibility includes recent imaging tests, certain blood levels within normal ranges, a specific type of tumor (HNSCC), and good physical condition.Check my eligibility
What is being tested?
The study compares usual treatment (radiation plus cisplatin) with radiation combined with docetaxel and cetuximab chemotherapy or adding atezolizumab immunotherapy. It aims to see which method is more effective in stopping cancer growth after surgery.See study design
What are the potential side effects?
Possible side effects include skin reactions from radiation, nausea from chemotherapy drugs like cisplatin and docetaxel, allergic reactions to cetuximab, fatigue from atezolizumab immunotherapy, as well as potential impacts on blood cell counts.

Eligibility Criteria

Inclusion Criteria

You may be eligible if you check “Yes” for the criteria below
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My head or neck cancer is stage III or IV but hasn't spread far.
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I had head and neck scans within the last 84 days before my surgery.
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I've been examined by a cancer specialist within the last 84 days.
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I have been examined by an ENT or head & neck surgeon before surgery.
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My kidney function tests are within normal limits.
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I agree to use effective birth control during the study.
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My cancer has spread beyond the lymph node capsule or was found at the edge of the removed tumor.
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I had a chest CT or CT/PET scan within the last 3 to 4 months.
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My cancer is a type of squamous cell carcinoma located in my head or neck.
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I agree to provide tissue samples for cancer analysis and have signed the study's consent form.
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I had surgery to remove a high-risk cancer in my mouth or throat area within the last 63 days.
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I have been mostly active and able to carry out all pre-disease activities until two weeks ago.
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I am 18 years old or older.

Timeline

Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~from date of randomization to death due to any cause, assessed up to 7 years
This trial's timeline: 3 weeks for screening, Varies for treatment, and from date of randomization to death due to any cause, assessed up to 7 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
Disease-free survival (DFS) (Phase II)
Overall survival (OS) (Phase III)
Secondary outcome measures
Diabetes Mellitus
Local-regional failure (LRF)
Patient-reported outcome, symptom burden
+2 more

Side effects data

From 2014 Phase 4 trial • 32 Patients • NCT01301729
59%
Leukopenia
56%
Neutropenia
34%
Hypoaesthesia
31%
Agranulocytosis
22%
Alopecia
22%
Asthenia
19%
Pyrexia
16%
Nail disorder
16%
Oedema peripheral
16%
Diarrhoea
16%
Hypophagia
13%
Neurotoxicity
13%
Alanine aminotransferase increased
13%
Cough
13%
Vomting
9%
Headache
9%
Aspartate aminotransferase increased
9%
Musculoskeletal pain
9%
Chest discomfort
9%
Rash
9%
Pigmentation disorder
9%
Nausea
9%
Bone marrow failure
9%
Anaemia
6%
Insomnia
6%
Transaminases increased
6%
Constipation
6%
Mouth ulceration
6%
Nasopharyngitis
6%
Paronychia
6%
Flushing
6%
Face oedema
6%
Thrombocytopenia
3%
Infection
3%
Upper respiratory tract infection
3%
Completed suicide
3%
Cataract
100%
80%
60%
40%
20%
0%
Study treatment Arm
Trastuzumab

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 4 (IMRT, cisplatin, atezolizumab)Experimental Treatment7 Interventions
Patients undergo IMRT QD five days a week for 6 weeks and receive concurrent cisplatin IV over 1-2 hours once weekly for 6 weeks. Starting 1 week before IMRT, patients also receive atezolizumab IV over 30-60 minutes every 3 weeks for up to 8 doses (weeks -1, 3, 6, 9, 12, 15, 18, and 21) in the absence of disease progression and unacceptable toxicity. Patients undergo CT scans and/or MRI, and collection of blood during follow-up.
Group II: Arm 3 (IMRT, docetaxel, cetuximab)Experimental Treatment8 Interventions
Patients receive cetuximab IV over 120 minutes on week 1 and over 60 minutes once weekly on weeks 2-7. Patients undergo IMRT as in Arm I and receive concurrent docetaxel once weekly for 6 weeks. Patients undergo CT scans and/or MRI, and collection of blood during follow-up.
Group III: Arm 2 (IMRT, docetaxel)Experimental Treatment7 Interventions
Patients undergo IMRT as in Arm I and receive concurrent docetaxel IV over 60 minutes once weekly for 6 weeks. Patients undergo CT scans and/or MRI, and collection of blood during follow-up. (CLOSED AS OF 20-MAR-2020)
Group IV: Arm 1 (IMRT, cisplatin)Experimental Treatment7 Interventions
Patients undergo IMRT QD five days a week for 6 weeks and receive concurrent cisplatin IV over 1-2 hours once weekly for 6 weeks. Patients undergo CT scans and/or MRI, and collection of blood during follow-up.
Treatment
First Studied
Drug Approval Stage
How many patients have taken this drug
Atezolizumab
2016
Completed Phase 3
~6040
Biospecimen Collection
2004
Completed Phase 1
~1850
Cetuximab
2011
Completed Phase 3
~2480
Cisplatin
2013
Completed Phase 3
~1940
Computed Tomography
2017
Completed Phase 2
~2710
Docetaxel
1995
Completed Phase 4
~5620
Intensity-Modulated Radiation Therapy
2010
Completed Phase 3
~2160
Magnetic Resonance Imaging
2017
Completed Phase 3
~1250

Find a Location

Who is running the clinical trial?

National Cancer Institute (NCI)Lead Sponsor
13,579 Previous Clinical Trials
41,223,866 Total Patients Enrolled
NRG OncologyOTHER
230 Previous Clinical Trials
100,041 Total Patients Enrolled
Paul M HarariPrincipal InvestigatorNRG Oncology
1 Previous Clinical Trials
464 Total Patients Enrolled

Media Library

Cetuximab (Monoclonal Antibodies) Clinical Trial Eligibility Overview. Trial Name: NCT01810913 — Phase 2 & 3
Squamous Cell Carcinoma Research Study Groups: Arm 1 (IMRT, cisplatin), Arm 2 (IMRT, docetaxel), Arm 3 (IMRT, docetaxel, cetuximab), Arm 4 (IMRT, cisplatin, atezolizumab)
Squamous Cell Carcinoma Clinical Trial 2023: Cetuximab Highlights & Side Effects. Trial Name: NCT01810913 — Phase 2 & 3
Cetuximab (Monoclonal Antibodies) 2023 Treatment Timeline for Medical Study. Trial Name: NCT01810913 — Phase 2 & 3
Squamous Cell Carcinoma Patient Testimony for trial: Trial Name: NCT01810913 — Phase 2 & 3

Frequently Asked Questions

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

What are the objectives of this research?

"The primary outcome of this study is disease-free survival (DFS) over a 7-year period. Secondary outcomes include quality of life, patient-reported outcomes, and local-regional failure."

Answered by AI

Do you know of any other times when Docetaxel has been trialed before?

"Docetaxel was first studied in 1997 at City of Hope Comprehensive Cancer Center. Since the initial study, there have been 2614 completed clinical trials. Currently, 1458 trials are recruiting patients, with a significant portion taking place in New york City."

Answered by AI

Are there a lot of hospitals part of this research in city?

"One hundred different medical facilities are running this study, with locations in New york, Peoria, Saint Louis, and many other places. If you want to enroll in the study, try to choose a site near you to limit travel."

Answered by AI

What is the most common reason that Docetaxel is given to patients?

"Docetaxel is a versatile chemotherapy medication, commonly used to treat metastatic bladder cancer as well as advanced testicular cancer, small cell lung cancer, and more."

Answered by AI

Are there any patients that can still enroll in this trial?

"If you are reading this, it is likely that you are eligible for this study. This study is still looking for participants, even though it was originally posted on 2013-03-18."

Answered by AI

Who else is applying?

What state do they live in?
New Jersey
Texas
What site did they apply to?
Banner University Medical Center - Tucson
What portion of applicants met pre-screening criteria?
Did not meet criteria
How many prior treatments have patients received?
1

Why did patients apply to this trial?

I'm interested to find out more about the clinical trial qualification and medication.
PatientReceived no prior treatments
~126 spots leftby Jan 2027