Carcinoma, Squamous CellPhase 2NCT02994069
Cisplatin + Radiation in SCCHN and Correlation With Oxidative Stress Markers
A Phase 2 study testing Cisplatin and XRT in people with Carcinoma, Squamous Cell and Head and Neck Cancer, run by Susanne Arnold at 1 site in United States.
Trial summary
Patients will receive standard of care radiation therapy to the primary tumor of the head and neck and involved nodal metastasis and draining nodal basin and either weekly cisplatin or every 3-week cisplatin in locally advanced SCCHN. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Carcinoma, Squamous Cell, Head and Neck Cancer
- What is being tested?
- Cisplatin and XRT
- Type of treatment
- Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 80 participants
- Where
- 1 siteUnited States
- Study dates
- 11 Apr 2017to 31 Oct 2029
- Phase
- Phase 2
- Are there results?
- Yes, posted in the registrySummary in the doctors' view
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Patients must have pathologically (histologically or cytologically) proven diagnosis of head and neck squamous cell carcinoma (HNSCC) involving the oral cavity, oropharynx, larynx, hypopharynx, paranasal sinuses or unknown primary squamous carcinoma limited to the head and neck region. Cohort 1: Unresectable locally advanced non-nasopharyngeal SCCHN without evidence of distant metastases. Cohort 2: Patients with non-nasopharyngeal SCCHN who have undergone gross total surgical resection within 63 days prior to registration. Patients must have at least 1 of the following high-risk pathologic features: extracapsular nodal extension, invasive cancer at the primary tumor resection margin (positive margin), lymphovascular invasion or perineural invasion, or the presence of multilevel nodal disease. Patients must be without evidence of distant metastases.
- Women of childbearing potential and male participants who are sexually active must agree to use a medically effective means of birth control.
- Cohort 1: Patients in Cohort 1 must have measurable disease, defined as at least one lesion that can be accurately measured in at least one dimension (longest diameter to be recorded for non-nodal lesions and short axis for nodal lesions) as ≥ 20 mm (≥ 2 cm) with conventional techniques or as ≥ 10 mm (≥ 1 cm) with spiral CT scan, MRI, or calipers by clinical exam. See Section 11 for the evaluation of measurable disease. Cohort 2: Subjects in the post-operative setting (Cohort 2) are not required to have measurable disease and response rate will not be assessed in cohort 2.
- Patients may have a history of prior head and neck malignancy, but must be able to tolerate full dose radiation and chemotherapy for the current head and neck cancer, as determined by the treating oncologist.
- Age ≥18 years.
- ECOG performance status 0, 1 or 2
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- Life expectancy of greater than 12 weeks.
- Patients must have normal organ and marrow function assessed within 14 days prior to registration as defined below: absolute neutrophil count ≥1,000/mcL, platelets ≥100,000/mcL, creatinine within normal institutional limits OR creatinine clearance ≥60 mL/min/1.73 m2 (for patients with creatinine levels above institutional normal).
- No prior chemotherapy for the current locally advanced SCCHN is allowed. Prior radiation or chemotherapy for a previous head and neck cancer is allowed provided full dose cisplatin and radiation can be delivered to the patient in this clinical trial and provided the patient is in remission from the prior head and neck cancer, and can undergo full dose radiation and chemotherapy for the current primary head and neck cancer.
- Women of child-bearing potential and men must agree to use adequate contraception (hormonal or barrier method of birth control; abstinence) prior to study entry, throughout the duration of active treatment and for 4 months after completion of chemotherapy and radiation.
- Cisplatin and radiation are known teratogens. For this reason, women of child-bearing potential and men must agree to use adequate contraception (hormonal or barrier method of birth control; abstinence) prior to study entry, throughout the duration of active treatment and for 4 months after completion of chemotherapy and radiation. Should a woman become pregnant or suspect she is pregnant while she or her partner is participating in this study, she should inform her treating physician immediately. Men treated or enrolled on this protocol must also agree to use adequate contraception prior to the study, for the duration of active study treatment, and for 4 months after completion of chemotherapy and radiation (both induction and definitive) administration.
- Ability to understand and the willingness to sign a written informed consent document.
Who cannot join
- Patients who have had chemotherapy or radiotherapy within 4 weeks (6 weeks for nitrosoureas or mitomycin C) prior to entering the study or those who have not recovered from adverse events due to agents administered more than 4 weeks earlier.
- Patients who are receiving any other investigational agents.
- History of allergic reactions attributed to compounds of similar chemical or biologic composition to cisplatin.
- Patients with greater than grade 2 hearing loss.
- No other prior malignancy is allowed except for the following: head and neck cancer in remission, adequately treated basal cell or squamous cell skin cancer, in situ cervical cancer, adequately treated previous Stage I or II cancer from which the patient is currently in complete remission or other cancer from which the patient has been disease-free for 2 years.
- Patients with nasopharynx or salivary gland primary site.
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- Patients with distant metastatic disease (M1c) from the current head and neck cancer including brain metastasis.
- Uncontrolled intercurrent illness including, but not limited to, ongoing or active infection (grade 3 or greater), symptomatic congestive heart failure, unstable angina pectoris, symptomatic cardiac arrhythmia, or psychiatric illness/social situations that would limit compliance with study requirements. Subjects with significant symptoms of congestive heart failure who would not be expected to tolerate the IV hydration for cisplatin are excluded.
- Pregnant women are excluded from this study because cisplatin and radiation are agents with the potential for teratogenic or abortifacient effects. Because there is an unknown but potential risk for adverse events in nursing infants secondary to treatment of the mother with cisplatin and radiation, breastfeeding should be discontinued if the mother is treated with cisplatin or radiation on this trial.
- HIV-positive patients with uncontrolled HIV despite combination antiretroviral therapy are ineligible because of the potential for increased risk of lethal infections when treated with marrow-suppressive therapy. Appropriate studies will be undertaken in patients receiving combination antiretroviral therapy when indicated
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Comparison of Every 3 Week Versus Weekly Cisplatin Concurrent With Radiation in Squamous Cell Carcinoma of the Head and Neck (SCCHN) and Correlation With Oxidative Stress Markers
Patients will receive standard of care radiation therapy to the primary tumor of the head and neck and involved nodal metastasis and draining nodal basin and either weekly cisplatin or every 3-week cisplatin in locally advanced SCCHN. The relationship between cisplatin toxicity and the level of reactive oxygen species generated by the drug in subjects with squamous cell carcinoma of the head and neck treated on this trial.
Read the detailed description
Patients will first be designated as either: a) Cohort 1 (locally advanced non-nasopharyngeal SCCHN that is unresectable) OR b) Cohort 2 (resected and at high risk of recurrence with at least one of the following criteria: extracapsular nodal extension, or invasive cancer at the primary tumor resection margin (positive margin), lymphovascular invasion or perineural invasion, pT3 or pT4 primary, or the presence of multilevel nodal disease. Subjects will then be randomized to receive either Arm 1 or Arm 2 cisplatin.
Radiation and Cisplatin will be given concurrently and should start on the same day, ±1 day. Radiation will continue without interruption whenever possible.
Treatment will consist of standard of care radiation therapy to the primary tumor of the head and neck and involved nodal metastasis and draining nodal basin, as determined by treating radiation oncologist. Patients will be randomized to receive cisplatin at 100 mg/m2 every 3 weeks (3 doses) during radiation versus cisplatin at 40 mg/m2 once weekly (7 doses) during radiation. This will provide similar cumulative doses of cisplatin in all arms of the study.IMRT will be delivered in 30-35 fractions over 6-7 weeks, 5 fractions weekly.
In the absence of treatment delays due to adverse event(s), treatment will continue for 7 weeks or until one of the following criteria applies:
Disease progression,Intercurrent illness that prevents further administration of treatment, Unacceptable adverse event(s), Patient decides to withdraw from the study, or General or specific changes in the patient's condition render the patient unacceptable for further treatment in the judgment of the investigator.
Patients will be followed for 2 years after completion of chemoradiation or until death, whichever occurs first, for toxicity and PFS.
- Conditions
- Carcinoma, Squamous Cell, Head and Neck Cancer
- Being tested
- Cisplatin, XRT
- Keywords
- Cisplatin, Squamous Cell, Carcinoma
- Medical subject headings
- Carcinoma, Squamous Cell, Head and Neck Neoplasms, Carcinoma
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
CisplatinDrug
Also called chemotherapy
Cisplatin
XRTRadiation
Radiation Therapy
| Study group | Role | What they receive |
|---|---|---|
| Every 3 Weeks Cisplatin + XRT | Experimental | Every 3 Weeks Cisplatin + XRT Receives: Drug: Cisplatin; Radiation: XRT |
| Weekly Cisplatin + XRT | Experimental | Weekly Cisplatin + XRT Receives: Drug: Cisplatin; Radiation: XRT |
What is being measured
The primary outcome is the main question the study is designed to answer.
CTCAE Grade 3-5 Cisplatin-related Adverse Event Rate (Percentage)
Rate of grade 3-5 cisplatin-related adverse events expressed as a percentage of each cohort of patients occurring within 90 days of initiation of concurrent radiation and chemotherapy; Rate calculated from number of patients with at least one cisplatin-related AEs with grade 3-5 within 90 days of the 1st treatment. This primary endpoint is the percentage of subjects experiencing cisplatin-related actual toxicities in each group estimated along with exact 95% binomial confidence intervals.
Measured: 90 days
Secondary outcomes (2)
Local Control Rates
2 year local control rate
Measured: 2 years
Survival
Overall survival
Measured: 2 years
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted15 Dec 2016 (estimated)
- Study start11 Apr 2017
- Primary completion3 Sep 2024
- Study completion31 Oct 2029 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
- Other trials for Carcinoma, Squamous CellStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 2
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 80 participants (actual)
Sponsor and investigators
- Lead sponsor
- Susanne Arnold
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor-investigator, Susanne Arnold, University of Kentucky
- Investigators
- Susanne Arnold, MD, Principal investigator, University of Kentucky
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02994069
- Sponsor's protocol ID
- MCC-16-HN-29
- Status last verified
- Sep 2026
- First submitted
- 12 Dec 2016
- Last updated
- 25 Sep 2026
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- Yes
- FDA-regulated drug
- Yes
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 25 Sep 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Comparison of Every 3 Week Versus Weekly Cisplatin Concurrent With Radiation in Squamous Cell Carcinoma of the Head and Neck (SCCHN) and Correlation With Oxidative Stress Markers
- ClinicalTrials.gov ID
- NCT02994069
- Acronym / sponsor ID
- MCC-16-HN-29
- Conditions
- Carcinoma, Squamous Cell, Head and Neck Cancer
- Keywords
- Cisplatin, Squamous Cell, Carcinoma
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- Active, not recruiting
- Enrolment
- 80 participants (actual)
- Lead sponsor
- Susanne ArnoldUniversity, hospital or other
- Study start
- 11 Apr 2017 (actual)
- Primary completion
- 3 Sep 2024 (actual)
- Study completion
- 31 Oct 2029 (estimated)
- First posted
- 15 Dec 2016 (estimated)
- Results
- Posted 14 Oct 2025
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
Patients will receive standard of care radiation therapy to the primary tumor of the head and neck and involved nodal metastasis and draining nodal basin and either weekly cisplatin or every 3-week cisplatin in locally advanced SCCHN. The relationship between cisplatin toxicity and the level of reactive oxygen species generated by the drug in subjects with squamous cell carcinoma of the head and neck treated on this trial.
Detailed description
Patients will first be designated as either: a) Cohort 1 (locally advanced non-nasopharyngeal SCCHN that is unresectable) OR b) Cohort 2 (resected and at high risk of recurrence with at least one of the following criteria: extracapsular nodal extension, or invasive cancer at the primary tumor resection margin (positive margin), lymphovascular invasion or perineural invasion, pT3 or pT4 primary, or the presence of multilevel nodal disease. Subjects will then be randomized to receive either Arm 1 or Arm 2 cisplatin.
Radiation and Cisplatin will be given concurrently and should start on the same day, ±1 day. Radiation will continue without interruption whenever possible.
Treatment will consist of standard of care radiation therapy to the primary tumor of the head and neck and involved nodal metastasis and draining nodal basin, as determined by treating radiation oncologist. Patients will be randomized to receive cisplatin at 100 mg/m2 every 3 weeks (3 doses) during radiation versus cisplatin at 40 mg/m2 once weekly (7 doses) during radiation. This will provide similar cumulative doses of cisplatin in all arms of the study.IMRT will be delivered in 30-35 fractions over 6-7 weeks, 5 fractions weekly.
In the absence of treatment delays due to adverse event(s), treatment will continue for 7 weeks or until one of the following criteria applies:
Disease progression,Intercurrent illness that prevents further administration of treatment, Unacceptable adverse event(s), Patient decides to withdraw from the study, or General or specific changes in the patient's condition render the patient unacceptable for further treatment in the judgment of the investigator.
Patients will be followed for 2 years after completion of chemoradiation or until death, whichever occurs first, for toxicity and PFS.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Every 3 Weeks Cisplatin + XRT | Experimental | Drug: Cisplatin, Radiation: XRTEvery 3 Weeks Cisplatin + XRT |
| Weekly Cisplatin + XRT | Experimental | Drug: Cisplatin, Radiation: XRTWeekly Cisplatin + XRT |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (12 listed)
- Patients must have pathologically (histologically or cytologically) proven diagnosis of head and neck squamous cell carcinoma (HNSCC) involving the oral cavity, oropharynx, larynx, hypopharynx, paranasal sinuses or unknown primary squamous carcinoma limited to the head and neck region. Cohort 1: Unresectable locally advanced non-nasopharyngeal SCCHN without evidence of distant metastases. Cohort 2: Patients with non-nasopharyngeal SCCHN who have undergone gross total surgical resection within 63 days prior to registration. Patients must have at least 1 of the following high-risk pathologic features: extracapsular nodal extension, invasive cancer at the primary tumor resection margin (positive margin), lymphovascular invasion or perineural invasion, or the presence of multilevel nodal disease. Patients must be without evidence of distant metastases.
- Women of childbearing potential and male participants who are sexually active must agree to use a medically effective means of birth control.
- Cohort 1: Patients in Cohort 1 must have measurable disease, defined as at least one lesion that can be accurately measured in at least one dimension (longest diameter to be recorded for non-nodal lesions and short axis for nodal lesions) as ≥ 20 mm (≥ 2 cm) with conventional techniques or as ≥ 10 mm (≥ 1 cm) with spiral CT scan, MRI, or calipers by clinical exam. See Section 11 for the evaluation of measurable disease. Cohort 2: Subjects in the post-operative setting (Cohort 2) are not required to have measurable disease and response rate will not be assessed in cohort 2.
- Patients may have a history of prior head and neck malignancy, but must be able to tolerate full dose radiation and chemotherapy for the current head and neck cancer, as determined by the treating oncologist.
- Age ≥18 years.
Key exclusion criteria (10 listed)
- Patients who have had chemotherapy or radiotherapy within 4 weeks (6 weeks for nitrosoureas or mitomycin C) prior to entering the study or those who have not recovered from adverse events due to agents administered more than 4 weeks earlier.
- Patients who are receiving any other investigational agents.
- History of allergic reactions attributed to compounds of similar chemical or biologic composition to cisplatin.
- Patients with greater than grade 2 hearing loss.
- No other prior malignancy is allowed except for the following: head and neck cancer in remission, adequately treated basal cell or squamous cell skin cancer, in situ cervical cancer, adequately treated previous Stage I or II cancer from which the patient is currently in complete remission or other cancer from which the patient has been disease-free for 2 years.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| CisplatinAlso: chemotherapyCisplatin | Drug | Every 3 Weeks Cisplatin + XRT, Weekly Cisplatin + XRT |
| XRTRadiation Therapy | Radiation | Every 3 Weeks Cisplatin + XRT, Weekly Cisplatin + XRT |
Primary outcome
CTCAE Grade 3-5 Cisplatin-related Adverse Event Rate (Percentage)
Time frame: 90 days
Rate of grade 3-5 cisplatin-related adverse events expressed as a percentage of each cohort of patients occurring within 90 days of initiation of concurrent radiation and chemotherapy; Rate calculated from number of patients with at least one cisplatin-related AEs with grade 3-5 within 90 days of the 1st treatment. This primary endpoint is the percentage of subjects experiencing cisplatin-related actual toxicities in each group estimated along with exact 95% binomial confidence intervals.
2 secondary outcomes
Local Control Rates
Time frame: 2 years
Survival
Time frame: 2 years
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 25 Sep 2026.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Susanne Arnold, MD principal investigator
University of Kentucky
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 2 study testing Cisplatin and XRT in people with Carcinoma, Squamous Cell and Head and Neck Cancer, run by Susanne Arnold at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 12 inclusion and 10 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: under way, not looking for participants, as of the sponsor's last update on 25 Sep 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
Yes. Results are posted in the registry (first posted 14 Oct 2025). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
CTCAE Grade 3-5 Cisplatin-related Adverse Event Rate (Percentage) (time frame: 90 days). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 25 Sep 2026.