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Squamous Cell CarcinomaPhase 2NCT02128906

Radiotherapy With Cisplatin vs. Docetaxel-cetuximab in HNSCC: ERCC1 Biomarker Enrichment and Interaction Design

A Phase 2 study testing Cisplatin, IMRT and Docetaxel in people with Squamous Cell Carcinoma, run by Christopher Wilke at 1 site in United States.

Recruiting

Looking for participants now. Contact the study team or a site below to ask about taking part.

Sites and contacts
Official record
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Trial summary

The goal of this clinical research study is to learn which chemotherapy combination may be more effective in treating locally advanced head and neck squamous cell carcinoma (HNSCC). The side effects of these combinations will also be studied. Read more about this study

Who is it for?
Ages 18 years and older
Conditions the study is for
Squamous Cell Carcinoma
What is being tested?
Cisplatin, IMRT and Docetaxel
Type of treatment
Surgery or procedure
Could I receive a placebo?
No, everyone receives an active treatment
How many people
120 participants
Where
1 siteUnited States
Study dates
23 Dec 2013to 16 Dec 2031
Phase
Phase 2
Are there results?
Not yet: the study is under way

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

  • Pathologically confirmed squamous cell carcinoma, undifferentiated carcinoma, or poorly differentiated carcinoma of the oropharynx, larynx, or hypopharynx with no evidence of distant metastasis. Biopsy sampling of primary tumor with pathology report documenting diagnostic tissue type is required.
  • Patients must have stage III, IVa or IVb disease as determined by imaging studies and complete head and neck exam. Staging evaluation should be in accordance with the American Joint Committee on Cancer Staging Manual, 7th edition.
  • Patients with oropharyngeal squamous cell carcinoma may have p16(+) or p16(-) disease; in these patients, p16 status must be known prior to randomization. Assessment of p16 status may occur locally or centrally. Note: The definition of p16(+) disease is diffuse nuclear and cytoplasmic staining in ≥ 70% of tumor cells.
  • Patients must be untreated with curative-intent surgery for current diagnosis of Stage III, IVa, or IVb disease. Diagnostic biopsy of primary tumor and/or nodal sites is permitted.
  • Diagnostic simple tonsillectomy is permitted, provided patient has RECIST-measurable residual tumor and/or nodal disease.
  • Patients with a second HNSCC primary tumor are eligible for this study, provided more than 2 years have elapsed since the first diagnosis of HNSCC, the original tumor was managed with surgery only (no adjuvant chemotherapy/radiotherapy), and has not recurred.
Show all 37Show fewer
  • Patients with simultaneous primaries or bilateral tumors are excluded, with the exception of patients with bilateral tonsil cancers or patients with T1-2, N0, M0 resected differentiated thyroid carcinoma, who are eligible.
  • No prior systemic treatment (chemotherapy or biologic/molecular targeted therapy) or radiation treatment for head and neck cancer.
  • Patients may have received chemotherapy or radiation for a previous, curatively treated non-HNSCC malignancy, provided at least 2 years have elapsed.
  • Patients must be untreated with radiation above the clavicles.
  • Patients with a history of curatively-treated non-HNSCC malignancy must be disease-free for at least 2 years except for carcinoma-in-situ of cervix, non-melanomatous skin cancer, or T1-2, N0, M0 resected differentiated thyroid carcinoma.
  • Diagnostic primary tumor tissue must be available for ERCC1 staining
  • Eastern Cooperative Oncology Group (ECOG) Performance Status 0-1 (See Appendix 8)
  • Age ≥ 18
  • Patients must have measurable disease according to RECIST 1.1
  • Patients must have the following laboratory values measured within 14 days of registration:
  • Absolute neutrophil count (ANC) > 1500/mm3
  • Hemoglobin (Hb) > 8.0 g/dL
  • Platelet count (PLT) > 100,000/mm3
  • Creatinine clearance ≥ 45 ml/min determined by 24-hour collection or estimated by the Cockraft-Gault formula:
  • Calculated Creatinine Clearance = [(140-age) X (actual body weight in kg) X (0.85 if female)]/(72 X serum creatinine)
  • Serum bilirubin < 2 mg/dL
  • AST (aspartate aminotransferase) and ALT (alanine aminotransferase) < 3 times upper limit of normal (ULN)
  • The following assessments are required within 14 days prior to registration: Na, K, Cl, glucose, Ca, Mg, and albumin. The following metabolic values will exclude patients from study enrollment:
  • Serum calcium (ionized or adjusted for albumin) < 7 mg/dl (1.75 mmol/L) or > 12.5 mg/dl (> 3.1 mmol/L) despite intervention to normalize levels
  • Magnesium < 0.9 mg/dl (< 0.4 mmol/L) or > 3 mg/dl (> 1.23 mmol/L) despite intervention to normalize levels
  • Potassium < 3.5 mmol/L or > 6 mmol/L despite intervention to normalize levels
  • Sodium < 130 mmol/L or > 155 mmol/L despite intervention to normalize levels Note: Patients with an initial magnesium < 0.5 mmol/L (1.2 mg/dl) may receive corrective magnesium supplementation but should continue to receive either prophylactic weekly infusion of magnesium and/or oral magnesium supplementation (eg, magnesium oxide) at the investigator's discretion.
  • No prior severe infusion reaction to a monoclonal antibody
  • Written informed consent must be obtained from all patients prior to beginning therapy. Patients should have the ability to understand and the willingness to sign a written informed consent document.
  • Informed consent must be obtained from all patients prior to beginning therapy, including consent for mandatory tissue submission for ERCC1 staining (and p16 staining if not locally conducted). Patients should have the ability to understand and the willingness to sign a written informed consent document.
  • No unstable angina or myocardial infarction within the prior 6 months; no symptomatic congestive heart failure; no serious cardiac arrhythmia requiring medication; no cerebrovascular ischemia or stroke within the past 6 months.
  • No uncontrolled intercurrent illness including active infection, uncontrolled diabetes, uncontrolled hypertension, or uncontrolled psychiatric illness which in the investigator's opinion would limit compliance with study requirements or compromise patient safety.
  • Women must not be pregnant or breast feeding because chemotherapy and/or cetuximab may be harmful to the fetus or the nursing infant. Pregnant women are excluded from this study because chemotherapy and/or cetuximab have the potential for teratogenic or abortifacient effects.
  • Women of child-bearing potential and men must agree to use adequate contraception (hormonal or barrier method of birth control) prior to study entry and for the duration of study participation. Should a woman become pregnant or suspect she is pregnant while in this study, she should inform her treating physician immediately. All females of childbearing potential must have a blood test or urine study within 14 days of registration to rule out pregnancy.
  • HIV-positive patients receiving combination anti-retroviral therapy are excluded from the study because of possible drug interactions with study drugs. Appropriate studies will be undertaken in patients receiving combination anti-retroviral therapy when indicated. Note: HIV testing is not required for entry into this protocol.
  • Patients may not be receiving any other anti-neoplastic investigational agents.

Who cannot join

None listed.

Trial locations and contacts

1 site in 1 country. Contact the study team or a site near you to ask about taking part.

Samantha Demko, RN contact

412-647-9015

albesl@upmc.edu

Brieana Marino, MS contact

412-647-8258

rowlesbm@upmc.edu

United States1 site, 1 recruiting

  • UPMC Hillman Cancer Center - Radiation Oncology

    Pittsburgh, Pennsylvania, 15232

    Samantha Demko, RN, 412-647-9015, albesl@upmc.edu

    Brieana Marino, MS, 412-647-8258, rowlesbm@upmc.edu

    Recruiting

Other trials in United States

About this study

Official title: A Randomized, Phase II Study of Definitive Radiotherapy With Concurrent Cisplatin vs. Docetaxel-cetuximab in Locally Advanced Head and Neck Squamous Cell Carcinoma: an ERCC1 Biomarker Enrichment and Interaction Design

The goal of this clinical research study is to learn which chemotherapy combination may be more effective in treating locally advanced head and neck squamous cell carcinoma (HNSCC). The side effects of these combinations will also be studied.

This study treatment consists of intensity-modulated radiation therapy (IMRT) and concurrent chemotherapy. For study chemotherapy, patients will be randomized between cisplatin or the combination of docetaxel and cetuximab. Subjects will be stratified depending on HPV status and the presence of ERCC-1 [4F9] in the tumor prior to randomization. The study will evaluate cisplatin vs. docetaxel-cetuximab in the overall population, and test which radiation and chemotherapy combination works best in relationship to how much ERCC-1 [4F9] is expressed in a tumor.

Read the detailed description

If randomized to the cisplatin arm, patients receive cisplatin, 40 mg/m2, administered intravenously (IV) once a week (+/- 2 days) for 7 weeks. Per investigator discretion, if radiation continues beyond 7 weeks due to technical factors (not toxicity delays), an 8th dose of concurrent cisplatin may be added.

Cisplatin can be given either before or after the radiation therapy fraction that is given on the same day. If a dose of cisplatin is omitted when radiotherapy is ongoing, it will not be made up or added to the end of treatment. The omitted dose and the reason for the omission should be recorded in the site's source documentation. If radiotherapy is held, cisplatin should be held during the treatment break and resumed when radiation restarts.

Patients randomized to Cetuximab arm receive cetuximab, 250 mg/m2, IV over 60 minutes on a weekly schedule (+/- 2 days). . Cetuximab may be administered either before or after the radiation fraction that is given on the same day. Docetaxel will be administered at least 30 minutes following cetuximab. It is not permitted to make up missed doses of cetuximab or docetaxel. If a radiation therapy treatment break occurs, cetuximab should be held. When radiation restarts, cetuximab should resume.

Cetuximab will be given once a week (+/- 2 days) for a total of 7 doses concurrent with radiation therapy and docetaxel.

Being tested
Cisplatin, IMRT, Docetaxel, Cetuximab
Keywords
ERCC1, oropharynx, larynx, hypopharynx, p16, radiotherapy, docetaxel, cetuximab, cisplatin, EGFR, head and neck
Medical subject headings
Carcinoma, Squamous Cell, Laryngeal Diseases

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • CisplatinDrug

    Also called Platinol

    Cisplatin 40 mg/m2 weekly x 7

  • IMRTRadiation

    IMRT: once daily, M-F, 7 weeks (70 Gy)

  • DocetaxelDrug

    Also called Taxotere

    Docetaxel 15 mg/m2 weekly x 7

  • CetuximabDrug

    Also called Erbitux

    Cetuximab 400 mg/m2 load, one week prior to IMRT Cetuximab 250 mg/m2 weekly x 7

Study groups in NCT02128906
Study groupRoleWhat they receive
Cisplatin-IMRTActive comparatorCisplatin 40 mg/m2 weekly x 7; IMRT: once daily, M-F, 7 weeks (70 Gy)
Receives: Drug: Cisplatin; Radiation: IMRT
Docetaxel-Cetuximab-IMRTActive comparatorDocetaxel 15 mg/m2 weekly x 7; Cetuximab 400 mg/m2 load, one week prior to IMRT; Cetuximab 250 mg/m2 weekly x 7; IMRT: once daily, M-F, 7 weeks (70 Gy)
Receives: Radiation: IMRT; Drug: Docetaxel; Drug: Cetuximab

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. Time To Progression (TTP)

    Time To Progression is the duration of time from date of study entry until the first appearance of new metastatic lesions or objective tumor progression in patients with increased tumoral ERCC1 expression. Progression is defined per RECIST v1.1 as at least a 20% increase in the sum of diameters of target lesions, taking as reference the smallest sum on study (this includes the baseline sum if that is the smallest on study). In addition to the relative increase of 20%, the sum must also demonstrate an absolute increase of at least 5 mm. (Note: the appearance of one or more new lesions is also considered progression).

    Measured: Up to 5 years

Secondary outcomes (15)

  1. Time to progression (TTP)

    Time To Progression is the duration of time from date of study entry until the appearance of new metastatic lesions or objective tumor progression in patients with decreased tumoral ERCC1 expression. Progression is defined per RECIST v1.1 as at least a 20% increase in the sum of diameters of target lesions, taking as reference the smallest sum on study (this includes the baseline sum if that is the smallest on study). In addition to the relative increase of 20%, the sum must also demonstrate an absolute increase of at least 5 mm. (Note: the appearance of one or more new lesions is also considered progression).

    Measured: Up to 5 years

  2. Local Control Rate (LRC)

    Proportions of patients with a tumor volume equal to or less than the tumor volume at start of radiotherapy.

    Measured: Up to 5 years

  3. Rate of distant metastases

    Proportion of patients with new metastatic lesions or objective tumor progression in patients with increased tumoral ERCC1 expression. Progression is defined per RECIST v1.1 as at least a 20% increase in the sum of diameters of target lesions, taking as reference the smallest sum on study (this includes the baseline sum if that is the smallest on study). In addition to the relative increase of 20%, the sum must also demonstrate an absolute increase of at least 5 mm. (Note: the appearance of one or more new lesions is also considered progression).

    Measured: Up to 5 years

  4. Validation candidate cutpoint

    Validation candidate cutpoint for decreased/normal vs. increased ERCC1 [4F9] expression in patients treated with cisplatin-IMRT. ERCC1 [4F9] expression is measured.

    Measured: Up to 5 years

  5. Response per RECIST 1.1

    Proportion of patients that experience response to treatment per RECIST v1.1 Per RECIST v1.1: Complete Response(CR): Disappearance of all target lesions. Any pathological lymph nodes (whether target or non-target)must have reduction in short axis to <10mm. Partial Response(PR): Atleasta30%decreaseinthesumof diameters of target lesions, taking as reference the baseline sum diameters.

    Measured: Up to 5 years

  6. 2-year (Time to Progression) TTP

    Proportion of patients with new metastatic lesions or objective tumor progression in patients with increased tumoral ERCC1 expression. Progression is defined per RECIST v1.1 as at least a 20% increase in the sum of diameters of target lesions, taking as reference the smallest sum on study (this includes the baseline sum if that is the smallest on study). In addition to the relative increase of 20%, the sum must also demonstrate an absolute increase of at least 5 mm. (Note: the appearance of one or more new lesions is also considered progression).

    Measured: At 2 years

  7. FACT-H&N FACT - Head & Neck

    The FACT-H\&N (version 4) consists of a cancer-specific questionnaire, FACT-G, in addition to 12 H\&N cancer-specific items (the HN subscale). FACT-G is a 27-item measure that assesses general cancer quality of life. The FACT-G contains 4 subscales: physical, social/family, emotional, and functional well-being. Individuals are asked to indicate how true 27 statements are for them, using the past 7 days as the timeframe. Responses range from not at all (0), to very much (4) on a 5-point scale. Higher scores indicate better quality of life.

    Measured: Up to 2 years

  8. Functional Assessment of Cancer Therapy (FACT-Cog)

    The FACT-Cog consists of 37 questions exploring four different subscales of the cognitive function: perceived cognitive impairments (CogPCI: 20 items); perceived cognitive abilities (CogPCA: 9 items); comments from others (CogOth: 4 items); and the impact of perceived cognitive impairments on quality of life (CogQOL: 4 items). The patient must answer the questions by referring to the last seven days, expressing how many times a given situation has occurred during this period.The total FACT-Cog score is the sum of the four subscales and ranges from 0-148. The higher the total score, the better the cognitive function, and the lower the impact on patients' quality of life.

    Measured: Up to 2 years

  9. Patient Health Questionnaire (PHQ-9)

    The PHQ-9 is a 9-question, self-administered instrument used to screen for the presence and severity of depression. Patients score how frequently they have been bothered by symptoms over the past 2 weeks. Scores range from 0-27 with 0 being least depressed and 27 most depressed. Scores are also monitored for change in values from visit to visit. Any value above 5 is an indication of the necessity of treatment intervention.

    Measured: Up to 2 years

  10. General Anxiety Disorder-7 (GAD-7)

    GAD-7 is a self-administered questionnaire of seven items which measures the frequency of GAD symptoms. Patients are monitored for change in values from visit to visit.Scores range from 0-21; severity of anxiety increases in each escalation of 5 points. Higher scores indicate increased severity of depression.

    Measured: Up to 2 years

  11. Modified Edmonton Symptom Assessment System (MESAS)

    MESAS asks cancer patients or caregivers to score 9 common cancer symptoms (along with a 10th symptom of "other") on a scale of 0-10. The scores are transferred to a ESAS Graph, thereby allowing the practitioner to identify severity of each symptom at time of assessment. Each symptom is rated from 0-10 on a numerical scale with 0 indicating an absence of the symptom and 10 indicating the worst possible severity of the symptom.

    Measured: Up to 2 years

  12. Impact of Events Scale - Intrusion (IES-I)

    A self-administered, 7-item test used to evaluate the level of distress caused in patients by a traumatic event. The patient is asked to consider their experience with cancer during the past week and then rate how much they were bothered by the experience, from 0 (not at all) to 4 (extremely). This yields a score between 0 and 28. Higher scores indicate a greater intrusion or impact of distress in the patient's life due to cancer.

    Measured: Up to 2 years

  13. Disease Related Blame Scale (DBS)

    A self-administered 2-item quiz used to evaluate the level of blame patients are experiencing regarding their cancer. Asked to consider the extent to which they contributed to contracting cancer on a scale of 1 (not at all) to 5 (completely), patients answer the questions to generate a number between 2 and 10. The lower the number, the less self-incrimination the patient is enduring.

    Measured: Up to 2 years

  14. Perceived Threat Scale (PTS)

    PTS is used to measure the patient's belief regarding the level of threat cancer poses to his/her life. Three questions are asked and the patient answers on a scale of 1 (not at all) to 5 (extremely). A final score between 3 and 15 is generated; the higher the number, the more threatened the subject is by the cancer diagnosis.

    Measured: Up to 2 years

  15. The Brief Pain Inventory

    The Brief Pain Inventory - Short Form is a 9 item self-administered questionnaire to measure the severity of a person' pain in musculoskeletal conditions and its impact on the patient's daily function. Patients are to consider their pain over the past 24 hours and rate it on a 0 (no pain) to 10 (most severe pain) scale for each of the following points: its most severe, its least sever, its average and its appearance right now. Patients are also to provide a score between 0 (no relief) and 10 (complete relief) regarding the effectiveness of treatments or medicines in the past 24 hours. Finally, patients rate the amount of interference pain has in 7 basic life functions on a scale of 0-10 with 0 being "no effect" and 10 being "complete interference".

    Measured: Up to 2 years

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted1 May 2014 (estimated)
  2. Study start23 Dec 2013
  3. Primary completion16 Dec 2031 (estimated)
  4. Study completion16 Dec 2031 (estimated)

Resources

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
120 participants (estimated)
IDs, dates and publications
ClinicalTrials.gov ID
NCT02128906
Sponsor's protocol ID
HCC 13-056
Status last verified
Apr 2026
First submitted
29 Apr 2014
Last updated
16 Apr 2026
Results posted
No
Data monitoring committee
Yes
FDA-regulated drug
Yes
FDA-regulated device
Yes
Individual data sharing
No

Questions about this trial

What is this clinical trial studying?

A Phase 2 study testing Cisplatin, IMRT and Docetaxel in people with Squamous Cell Carcinoma, run by Christopher Wilke 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 37 inclusion and 0 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: looking for participants now, as of the sponsor's last update on 16 Apr 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?

This study is still under way. Results are not available in the source record yet.

How can a doctor refer a patient or contact the research team?

Contact Samantha Demko, RN (412-647-9015, albesl@upmc.edu), or a site near the patient. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Time To Progression (TTP) (time frame: Up to 5 years). It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT02128906.

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 16 Apr 2026.

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