Radiation Therapy With or Without Cisplatin for Head and Neck Squamous Cell Carcinoma
This study is looking at how well radiation therapy, with or without the drug cisplatin, works for patients with stage III-IVA squamous cell carcinoma (a type of cancer) of the head and neck. You would have already had surgery for your cancer. Radiation therapy uses high-energy X-rays to kill cancer cells, and cisplatin is a chemotherapy drug that helps stop cancer cells from growing and spreading. Researchers want to see if adding cisplatin to radiation therapy is more effective. The study will measure how long patients live without their disease returning, a new head and neck cancer appearing, or death, for up to 10 years. This study is for adults aged 18 and older with specific types of head and neck squamous cell carcinoma.
- Study design
- This is an interventional study with a planned enrollment of 189 participants. Participants will be randomly assigned to receive either radiation therapy alone or radiation therapy with cisplatin.
- What's involved
- Participants will undergo intensity-modulated radiation therapy (IMRT) once daily, 5 days a week for 6 weeks. Correlative studies, including laboratory biomarker analysis, will also be performed.
- Compensation
- Not stated in the trial record.
- Follow-up
- Disease-free survival will be assessed from the date of randomization up to 10 years.
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NCT02734537
Radiation Therapy With or Without Cisplatin in Treating Patients With Stage III-IVA Squamous Cell Carcinoma of the Head and Neck Who Have Undergone Surgery
Recruiting
PHASE2Ages 18+InterventionalTreatmentECOG-ACRIN Cancer Research GroupGovernment-funded
~189 participants
Updated 2026-08-19 on ClinicalTrials.gov
What's tested:CisplatinIntensity-Modulated Radiation TherapyLaboratory Biomarker Analysis
At a glance
Recruiting sites
463 of 679 listed sites are recruiting right now
RecruitingSuspended, closed, or not yet open
What they're measuring
Disease-free survival in patients with stage III-IV disease and disruptive p53 mutation
Measured over Date of randomization to the date of recurrence, second primary tumor from the head and neck region, or death, assessed up to 10 years
Conditions
Where it's being run
679 sites across 47 statesMichigan78
Illinois68
Minnesota59
Ohio47
Pennsylvania39
Wisconsin35
Washington32
Missouri23
Study leadership
- Robert Ferris · PRINCIPAL_INVESTIGATOR · ECOG-ACRIN Cancer Research Group
Who to contact
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Do you actually qualify for this trial?
Add a private profile and we'll compare every criterion below against your situation — and tell you which ones are met, uncertain, or excluding.
Eligibility criteria
Inclusion
PRE-REGISTRATION (STEP 0)
Pathologically proven diagnosis of squamous cell carcinoma (including variants such as verrucous carcinoma, spindle cell carcinoma, carcinoma not otherwise specified \[NOS\]) of the head/neck (oral cavity, oropharynx, hypopharynx or larynx); pathologic stage III or IVA (American Joint Committee on Cancer \[AJCC\] 8): T3-T4a, N0-3, M0 or T1-T2, N1-3, M0
Patient has undergone total resection of the primary tumor with curative intent
NOTE: Patient is to be pre-registered to screening (Step 0) and tissue submitted to Foundation Medicine as soon as possible after surgery in order to meet the 8 week deadline to register the patient to Step 1 after surgery; full assay minimum turn-around time is 17-24 days
For oropharynx primary tumors, the patient must have negative human papillomavirus (HPV) status of the tumor as determined by p16 protein expression using immunohistochemistry (IHC)
Patients with, per the operative and/or pathology report, positive margin(s) (tumor present at the cut or inked edge of the tumor) which is not superceded by an additional margin of tumor-negative tissue, nodal extracapsular extension, and/or gross residual disease after surgery are not eligible
A paraffin-embedded surgical tumor tissue specimen has been located is available for shipment to Foundation Medicine, Inc. following pre-registration
NOTE: Complete the EA3132-specific FoundationOne requisition form
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; patients must not have received chemotherapy or investigational therapy within two years of surgical resection of the primary tumor
Patient must not have had previous irradiation to the head and neck that would result in overlap in radiation fields for the current disease
Patients with recurrent disease or multiple primaries are ineligible
RANDOMIZATION (STEP 1)
NOTE: Patient must meet all eligibility criteria outlined in pre-registration; patient may not be randomized until site has been notified that the central determination of p53 mutation status of the surgical tumor tissue has been completed and site has been notified of assay completion
Per the operative report, the gross total resection of the primary tumor with curative intent was completed within 8 weeks prior to randomization
The patient must have the following assessments done =\< 8 weeks prior to randomization:
Examination by a head and neck surgeon
Chest x-ray (or chest computed tomography \[CT\] scan or CT/positron emission tomography \[PET\] of the chest or magnetic resonance imaging \[MRI\]) to rule out distant metastatic disease
Patient has Eastern Cooperative Oncology Group (ECOG) performance status 0-1 within 2 weeks prior to randomization
Women must not be pregnant or breast-feeding; females of childbearing potential must have a blood or urine study within 2 weeks prior to randomization to rule out pregnancy; a female of childbearing potential is any woman, regardless of sexual orientation or whether they have undergone tubal ligation, who meets the following criteria: 1) has not undergone a hysterectomy or bilateral oophorectomy; or 2) has not been naturally postmenopausal for at least 24 consecutive months (i.e., has had menses at any time in the preceding 24 consecutive months)
Women of childbearing potential and sexually active males must be strongly advised to use an accepted and effective method of contraception or to abstain from sexual intercourse for the duration of their participation in the study and until 60 days from the last study treatment
Absolute neutrophil count \>= 1,500/mm\^3 within 4 weeks prior to randomization
Platelets \>= 100,000/mm\^3 within 4 weeks prior to randomization
Total bilirubin =\< the upper limit of normal (ULN) within 4 weeks prior to randomization
Calculated creatinine clearance must be \> 60 ml/min using the Cockcroft-Gault formula within 4 weeks prior to randomization
Patient must not have an intercurrent illness likely to interfere with protocol therapy
What this trial measures
- Disease-free survival in patients with stage III-IV disease and disruptive p53 mutationDate of randomization to the date of recurrence, second primary tumor from the head and neck region, or death, assessed up to 10 years
Kaplan-Meier estimates will be used to estimate event-time distributions and comparison between arms will be performed using a log-rank test.