Clinical Stage III HPV-Mediated (p16-Positive) Oropharyngeal Carcinoma AJCC v8Phase 2NCT04106362
Radiation Therapy and Cisplatin With or Without Cetuximab in Treating Patients With HPV Positive, KRAS-Variant Stage III-IV Oropharyngeal Squamous Cell Carcinoma
A Phase 2 study testing Cetuximab, Cisplatin and Quality-of-Life Assessment in people with Clinical Stage III HPV-Mediated (p16-Positive) Oropharyngeal Carcinoma AJCC v8 and Clinical Stage IV HPV-Mediated (p16-Positive) Oropharyngeal Carcinoma AJCC v8, run by Jonsson Comprehensive Cancer Center at 1 site in United States.
Trial summary
This phase II trial studies how well radiation therapy and cisplatin with or without cetuximab works in treating patients with human papillomavirus (HPV) positive, KRAS-variant stage III-IV oropharyngeal squamous cell carcinoma. Radiation therapy uses high energy x-rays to kill tumor cells and shrink tumors. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Clinical Stage III HPV-Mediated (p16-Positive) Oropharyngeal Carcinoma AJCC v8, Clinical Stage IV HPV-Mediated (p16-Positive) Oropharyngeal Carcinoma AJCC v8, KRAS Protein Variant
- What is being tested?
- Cetuximab, Cisplatin and Quality-of-Life Assessment
- Type of treatment
- Injection or infusion, Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 1 participants
- Where
- 1 siteUnited States
- Study dates
- 14 Jan 2020to 23 May 2023
- Phase
- Phase 2
- Are there results?
- None posted in the registry
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
- Written informed consent obtained from the patient/legal representative prior to performing any protocol-related procedures, including screening evaluation
- Newly diagnosed, untreated, biopsy-proven HPV+ squamous cell carcinoma of the oropharynx. Cytologic diagnosis from a cervical lymph node is sufficient in the presence of clinical evidence of a primary tumor in the oropharynx. Clinical evidence should be documented, may consist of palpation, imaging, or endoscopic evaluation and should be sufficient to estimate the size of the primary (for T stage). HPV-positivity will be defined as tumors that are p16-positive by immunohistochemistry
- Selective stage III-IV disease (T3-T4 or N2-N3 disease) by American Joint Committee on Cancer (AJCC) 8th edition as determined by a computed tomography (CT) scan or magnetic resonance imaging (MRI) of the head and neck, CT neck, chest, abdomen, pelvis or a PET =< 6 weeks of registration
- Confirmation of KRAS-variant status as assessed by genotyping from a cheek swab sample at MiraDx
- Lifetime cumulative smoking history of < 10 pack-years. The cumulative total of the number of pack-years during each period of active smoking is the lifetime cumulative history
- Note: Investigators are discouraged from enrolling patients with a history of very sustained use (such as several years or more) of non-cigarette tobacco products alone given that the effect of non-cigarette tobacco products on the survival of patients with p16-positive oropharyngeal cancers is undefined
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- Eastern Cooperative Oncology Group (ECOG) performance status of 0 ? 1 within 60 days prior to registration
- Hemoglobin >= 9 g/dL (5.58 mmol/L) (within 2 weeks prior to registration)
- Absolute neutrophil count (ANC) >= 1500/uL (cells/mm^3) (within 2 weeks prior to registration)
- Platelet count >= 100,000/uL (cells/mm^3) (within 2 weeks prior to registration)
- Total bilirubin =< 1.5 mg/dL (25.65 umol/L) or =< 3.0 mg/dL if the patient has a history of Gilbert?s disease (within 2 weeks prior to registration)
- Aspartate transaminase (AST)/alanine transaminase (ALT) =< 2 x the institutional upper limit of normal (ULN) (within 2 weeks prior to registration)
- Serum creatinine =< 1.5 x institutional ULN OR creatinine clearance (measured via 24-hour urine collection) >= 50 ml/min (that is, if serum creatinine is > 1.5 times the ULN, a 24-hour urine collection to calculate creatinine clearance must be performed) (within 2 weeks prior to registration)
- Female subjects must either be of non-reproductive potential (i.e., post-menopausal by history: >= 60 years old and no menses for at least 1 year without an alternative medical cause, OR history of hysterectomy, OR history of bilateral tubal ligation, OR history of bilateral oophorectomy) or must have a negative serum pregnancy test within 7 days prior to enrollment
- Female subjects of child bearing potential and male subjects with partners of child bearing potential must agree to adequate contraceptive measures (hormonal or barrier methods) during treatment and for 2 months after the last dose of cetuximab
- Subject is willing and able to comply with the protocol for the duration of the study including undergoing treatment, scheduled visits, and examinations including follow up
Who cannot join
- Patients with biopsy-proven metastatic, HPV-negative, KRAS-variant negative, or recurrent head and neck squamous cell carcinoma (HNSCC)
- Patients with primary site of tumor outside of the oropharynx, specifically of the oral cavity, salivary glands, nasal cavity, paranasal sinuses, larynx, hypopharynx, or nasopharynx
- Patients with prior radiation therapy (RT) that would result in overlap of radiation therapy treatment fields (superficial x-ray of skin lesions excluded)
- Gross total excision (ex. tonsillectomy) of the primary tumor; however, partial removal of the tumor to alleviate an impending airway obstruction does not make the patient ineligible. Initial surgical treatment, excluding diagnostic biopsy of the primary site or nodal sampling of neck disease, as well as radical or modified neck dissection is not permitted
- Prior systemic chemotherapy or biologic therapy for the study cancer; note that prior chemotherapy or biologic therapy for a different cancer is allowable
- Prior therapy that specifically and directly targets the EGFR pathway
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- History of another primary invasive malignancy except for:
- Malignancy treated with curative intent and with no known active disease >= 3 years before the first dose of study drug and of low potential risk for recurrence
- Adequately treated non-melanoma skin cancer or lentigo maligna without evidence of disease
- Adequately treated low risk prostate cancer without evidence of disease
- Adequately treated carcinoma in situ without evidence of disease e.g., cervical cancer in situ, and ductal breast carcinoma in situ (DCIS)
- History of infusion reaction or hypersensitivity to cetuximab OR allergic reactions attributed to compounds of chemical or biologic composition similar to those of cetuximab
- Documented uncontrolled intercurrent illness or co-morbidity including, but not limited to, ongoing or active bacterial or fungal infection requiring intravenous antibiotics, uncontrolled congestive heart failure, cardiomyopathy, uncontrolled hypertension, unstable angina pectoris, cardiac arrhythmia, acquired immune deficiency syndrome (AIDS) based upon current Centers for Disease Control and Prevention (CDC) definition, or psychiatric illness/social situations that would limit compliance with study requirements or compromise the ability of the subject to give written informed consent
- Female subjects who are pregnant or breastfeeding as well as male or female patients of reproductive potential who are not employing an effective method of birth control
- Patients with clinically relevant coronary artery disease or history of myocardial infarction in the last 12 months or high-risk of uncontrolled arrhythmia or uncontrolled cardiac insufficiency
- Patients with uncontrolled or poorly-controlled hypertension (> 180 mmHg systolic or > 130 mmHg diastolic)
- Any condition that, in the opinion of the investigator, would interfere with evaluation of study treatment or interpretation of patient safety or study results
- Involvement in the planning and/or conduct of the study
Trial locations and contacts
1 site in 1 country.
United States1 site
UCLA / Jonsson Comprehensive Cancer Center
Los Angeles, California, 90095
About this study
Official title: Randomized Phase II Trial of Radiotherapy With Concurrent Cisplatin +/- Concurrent Cetuximab for HPV-Positive Oropharyngeal Squamous Cell Carcinoma (OPSCC) in KRAS-Variant Patients
This phase II trial studies how well radiation therapy and cisplatin with or without cetuximab works in treating patients with human papillomavirus (HPV) positive, KRAS-variant stage III-IV oropharyngeal squamous cell carcinoma. Radiation therapy uses high energy x-rays to kill tumor cells and shrink tumors. Drugs used in chemotherapy, such as cisplatin, work in different ways to stop the growth of tumor cells, either by killing the cells, by stopping them from dividing, or by stopping them from spreading. Immunotherapy with monoclonal antibodies, such as cetuximab, may help the body?s immune system attack the cancer, and may interfere with the ability of tumor cells to grow and spread. Giving radiation therapy, cisplatin, and cetuximab may work better in treating patients with HPV positive, KRAS-variant oropharyngeal squamous cell carcinoma compared to radiation therapy and cisplatin alone.
Read the detailed description
PRIMARY OBJECTIVES:
- To determine the efficacy of radiation therapy with concurrent cisplatin combined with concurrent cetuximab in KRAS-variant oropharyngeal squamous cell carcinoma (OPSCC) patients in terms of overall survival (OS) at 2 years.
SECONDARY OBJECTIVES:
- To determine the efficacy of radiation therapy with concurrent cisplatin combined with concurrent cetuximab in KRAS-variant OPSCC patients in terms of patterns of failure at 6 months and 2 years.
II. To determine the efficacy of radiation therapy with concurrent cisplatin combined with concurrent cetuximab in KRAS-variant OPSCC patients in terms of progression-free survival (PFS) at 2 years.
III. To determine the efficacy of radiation therapy with concurrent cisplatin combined with concurrent cetuximab in KRAS-variant OPSCC patients in terms of locoregional control (LRC) at 2 years.
IV. To determine the efficacy of radiation therapy with concurrent cisplatin combined with concurrent cetuximab in KRAS-variant OPSCC patients in terms of distant metastasis-free survival (DMFS) at 2 and 5 years.
- To determine the efficacy of radiation therapy with concurrent cisplatin combined with concurrent cetuximab in KRAS-variant OPSCC patients in terms of OS at 5 years.
VI. To determine the safety of radiation therapy with concurrent cisplatin combined with concurrent cetuximab in KRAS-variant OPSCC patients in terms of acute toxicity profiles at the end of radiation, at 1 month, and at 6 months.
VII. To determine the safety of radiation therapy with concurrent cisplatin combined with concurrent cetuximab in KRAS-variant OPSCC patients in terms of late toxicity profiles at 1 and 2 years.
VIII. To determine the safety of radiation therapy with concurrent cisplatin combined with concurrent cetuximab in KRAS-variant OPSCC patients in terms of patient-reported swallowing outcomes at 6 months and 1 and 2 years.
IX. To assess the predictive value of fludeoxyglucose (FDG)-positron emission tomography (PET) at 10-14 weeks post-treatment.
- To assess the predictive value of additional blood and tissue biomarkers for disease outcomes at 2 years.
EXPLORATORY OBJECTIVES:
- To evaluate the impact of cetuximab on the immune response as well as treatment outcome and toxicity.
II. To evaluate biomarkers for immune response in HPV-associated OPSCC through saliva and blood samples to be collected prior to treatment and at each follow-up visit.
III. To evaluate for additional checkpoint targets through tumor tissue taken at the time of initial biopsy and profiled for tumor infiltrating lymphocytes, activation markers, and antigen-specific T-cell receptor (TCR) utilization/diversity.
OUTLINE: Patients are randomized to 1 of 2 arms.
ARM I: Beginning on day 0, patients undergo radiation therapy over 6 weeks for a total of 35 fractions. Patients also receive cisplatin intravenously (IV) over 1-2 hours on days 0 and 21.
ARM II: Patients receive cetuximab IV over 120 minutes 5-7 days prior to start of radiation therapy and then IV over 60 minutes weekly on Monday or Tuesday for 7 weeks. Patients also undergo radiation therapy and receive cisplatin as in Arm I.
After completion of study treatment, patients are followed up at 2-4 weeks, every 12 weeks for 2 years, and then every 3-12 months for up to 5 years.
- Conditions
- Clinical Stage III HPV-Mediated (p16-Positive) Oropharyngeal Carcinoma AJCC v8, Clinical Stage IV HPV-Mediated (p16-Positive) Oropharyngeal Carcinoma AJCC v8, KRAS Protein Variant, Pathologic Stage III HPV-Mediated (p16-Positive) Oropharyngeal Carcinoma AJCC v8, Pathologic Stage IV HPV-Mediated (p16-Positive) Oropharyngeal Carcinoma AJCC v8
- Being tested
- Cetuximab, Cisplatin, Quality-of-Life Assessment, Questionnaire Administration, Radiation Therapy
- Medical subject headings
- Oropharyngeal Neoplasms
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
CetuximabBiological
Also called Cetuximab Biosimilar CDP-1, Cetuximab Biosimilar CMAB009, Cetuximab Biosimilar KL 140, Chimeric Anti-EGFR Monoclonal Antibody
Given IV
CisplatinDrug
Also called Abiplatin, Blastolem, Briplatin, CDDP
Given IV
Quality-of-Life AssessmentOther
Also called Quality of Life Assessment
Ancillary studies
Questionnaire AdministrationOther
Ancillary studies
Radiation TherapyRadiation
Also called Cancer Radiotherapy, Irradiate, Irradiated, irradiation
Undergo radiation therapy
| Study group | Role | What they receive |
|---|---|---|
| Arm I (radiation therapy, cisplatin) | Active comparator | Beginning on day 0, patients undergo radiation therapy over 6 weeks for a total of 35 fractions. Patients also receive cisplatin IV over 1-2 hours on days 0 and 21. Receives: Drug: Cisplatin; Other: Quality-of-Life Assessment; Other: Questionnaire Administration; Radiation: Radiation Therapy |
| Arm II (cetuximab, radiation therapy, cisplatin) | Experimental | Patients receive cetuximab IV over 120 minutes 5-7 days prior to start of radiation therapy and then IV over 60 minutes weekly on Monday or Tuesday for 7 weeks. Patients also undergo radiation therapy and receive cisplatin as in Arm I. Receives: Biological: Cetuximab; Drug: Cisplatin; Other: Quality-of-Life Assessment; Other: Questionnaire Administration; Radiation: Radiation Therapy |
What is being measured
The primary outcome is the main question the study is designed to answer.
Overall survival (OS)
OS will be estimated in each study arm by Kaplan-Meier estimate. Summaries of the number and percentage of patients who have died, are still in survival follow-up, are lost to follow-up and have withdrawn consent will be provided along with median OS. Furthermore, a binomial test of proportions will be used to test difference in 2-year OS between the two arms. Exact tests and continuity correction strategies will be considered when appropriate.
Measured: From time of randomization to death due to any cause, assessed at 2 years
Secondary outcomes (4)
Primary tumor control
Will be determined by Response Evaluation Criteria in Solid Tumors version (v). 1.1. Kaplan-Meier estimate will be used to describe primary control rate for each arm. Furthermore, log-rank test will be used to test the difference between primary tumor control between the two arms.
Measured: Up to 5 years
Locoregional recurrence rate
Will be determined by surveillance imaging, with failure defined as appearance of new disease in the head and neck from the date of randomization. Kaplan-Meier estimate will be used to describe locoregional recurrence rate for each arm. Furthermore, log-rank test will be used to test difference in locoregional recurrence rates between the two arms.
Measured: Up to 5 years
Acute toxicity
Will be evaluated using the Common Terminology Criteria for Adverse Events (CTCAE) v5.0. The safety analysis set will be used for safety analyses. The overall safety and tolerability will be assessed throughout the study period. All adverse event (AE) data will be listed individually by treatment group and patient identifier.
Measured: Up to 5 years
Late toxicity
Will be evaluated using the CTCAE v5.0. The safety analysis set will be used for safety analyses. The overall safety and tolerability will be assessed throughout the study period. All AE data will be listed individually by treatment group and patient identifier.
Measured: Up to 5 years
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted27 Sep 2019
- Study start14 Jan 2020
- Primary completion23 May 2023
- Study completion23 May 2023
Why it stopped: low enrollment
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Clinical Stage III HPV-Mediated (p16-Positive) Oropharyngeal Carcinoma AJCC v8Studies of the same condition, open and under way.
- More trials run by Jonsson Comprehensive Cancer CenterThe sponsor's other registered studies.
- 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
- 1 participants (actual)
Sponsor and investigators
- Lead sponsor
- Jonsson Comprehensive Cancer Center
- Sponsor type
- University, hospital or other
- Collaborators
- Eli Lilly and Company
- Responsible party
- Sponsor
- Investigators
- Robert K Chin, Principal investigator, UCLA / Jonsson Comprehensive Cancer Center
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04106362
- Sponsor's protocol ID
- 19-000543
- Other IDs
- NCI-2019-03636
- Status last verified
- May 2023
- First submitted
- 25 Sep 2019
- Last updated
- 1 Jun 2023
- Results posted
- No
- 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 1 Jun 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Randomized Phase II Trial of Radiotherapy With Concurrent Cisplatin +/- Concurrent Cetuximab for HPV-Positive Oropharyngeal Squamous Cell Carcinoma (OPSCC) in KRAS-Variant Patients
- ClinicalTrials.gov ID
- NCT04106362
- Acronym / sponsor ID
- 19-000543
- Conditions
- Clinical Stage III HPV-Mediated (p16-Positive) Oropharyngeal Carcinoma AJCC v8, Clinical Stage IV HPV-Mediated (p16-Positive) Oropharyngeal Carcinoma AJCC v8, KRAS Protein Variant, Pathologic Stage III HPV-Mediated (p16-Positive) Oropharyngeal Carcinoma AJCC v8, Pathologic Stage IV HPV-Mediated (p16-Positive) Oropharyngeal Carcinoma AJCC v8
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- TerminatedReason stopped: low enrollment
- Enrolment
- 1 participants (actual)
- Lead sponsor
- Jonsson Comprehensive Cancer CenterUniversity, hospital or other
- Collaborators
- Eli Lilly and Company
- Study start
- 14 Jan 2020 (actual)
- Primary completion
- 23 May 2023 (actual)
- Study completion
- 23 May 2023 (actual)
- First posted
- 27 Sep 2019 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
This phase II trial studies how well radiation therapy and cisplatin with or without cetuximab works in treating patients with human papillomavirus (HPV) positive, KRAS-variant stage III-IV oropharyngeal squamous cell carcinoma. Radiation therapy uses high energy x-rays to kill tumor cells and shrink tumors. Drugs used in chemotherapy, such as cisplatin, work in different ways to stop the growth of tumor cells, either by killing the cells, by stopping them from dividing, or by stopping them from spreading. Immunotherapy with monoclonal antibodies, such as cetuximab, may help the body?s immune system attack the cancer, and may interfere with the ability of tumor cells to grow and spread. Giving radiation therapy, cisplatin, and cetuximab may work better in treating patients with HPV positive, KRAS-variant oropharyngeal squamous cell carcinoma compared to radiation therapy and cisplatin alone.
Detailed description
PRIMARY OBJECTIVES:
- To determine the efficacy of radiation therapy with concurrent cisplatin combined with concurrent cetuximab in KRAS-variant oropharyngeal squamous cell carcinoma (OPSCC) patients in terms of overall survival (OS) at 2 years.
SECONDARY OBJECTIVES:
- To determine the efficacy of radiation therapy with concurrent cisplatin combined with concurrent cetuximab in KRAS-variant OPSCC patients in terms of patterns of failure at 6 months and 2 years.
II. To determine the efficacy of radiation therapy with concurrent cisplatin combined with concurrent cetuximab in KRAS-variant OPSCC patients in terms of progression-free survival (PFS) at 2 years.
III. To determine the efficacy of radiation therapy with concurrent cisplatin combined with concurrent cetuximab in KRAS-variant OPSCC patients in terms of locoregional control (LRC) at 2 years.
IV. To determine the efficacy of radiation therapy with concurrent cisplatin combined with concurrent cetuximab in KRAS-variant OPSCC patients in terms of distant metastasis-free survival (DMFS) at 2 and 5 years.
- To determine the efficacy of radiation therapy with concurrent cisplatin combined with concurrent cetuximab in KRAS-variant OPSCC patients in terms of OS at 5 years.
VI. To determine the safety of radiation therapy with concurrent cisplatin combined with concurrent cetuximab in KRAS-variant OPSCC patients in terms of acute toxicity profiles at the end of radiation, at 1 month, and at 6 months.
VII. To determine the safety of radiation therapy with concurrent cisplatin combined with concurrent cetuximab in KRAS-variant OPSCC patients in terms of late toxicity profiles at 1 and 2 years.
VIII. To determine the safety of radiation therapy with concurrent cisplatin combined with concurrent cetuximab in KRAS-variant OPSCC patients in terms of patient-reported swallowing outcomes at 6 months and 1 and 2 years.
IX. To assess the predictive value of fludeoxyglucose (FDG)-positron emission tomography (PET) at 10-14 weeks post-treatment.
- To assess the predictive value of additional blood and tissue biomarkers for disease outcomes at 2 years.
EXPLORATORY OBJECTIVES:
- To evaluate the impact of cetuximab on the immune response as well as treatment outcome and toxicity.
II. To evaluate biomarkers for immune response in HPV-associated OPSCC through saliva and blood samples to be collected prior to treatment and at each follow-up visit.
III. To evaluate for additional checkpoint targets through tumor tissue taken at the time of initial biopsy and profiled for tumor infiltrating lymphocytes, activation markers, and antigen-specific T-cell receptor (TCR) utilization/diversity.
OUTLINE: Patients are randomized to 1 of 2 arms.
ARM I: Beginning on day 0, patients undergo radiation therapy over 6 weeks for a total of 35 fractions. Patients also receive cisplatin intravenously (IV) over 1-2 hours on days 0 and 21.
ARM II: Patients receive cetuximab IV over 120 minutes 5-7 days prior to start of radiation therapy and then IV over 60 minutes weekly on Monday or Tuesday for 7 weeks. Patients also undergo radiation therapy and receive cisplatin as in Arm I.
After completion of study treatment, patients are followed up at 2-4 weeks, every 12 weeks for 2 years, and then every 3-12 months for up to 5 years.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Arm I (radiation therapy, cisplatin) | Active comparator | Drug: Cisplatin, Other: Quality-of-Life Assessment, Other: Questionnaire Administration, Radiation: Radiation TherapyBeginning on day 0, patients undergo radiation therapy over 6 weeks for a total of 35 fractions. Patients also receive cisplatin IV over 1-2 hours on days 0 and 21. |
| Arm II (cetuximab, radiation therapy, cisplatin) | Experimental | Biological: Cetuximab, Drug: Cisplatin, Other: Quality-of-Life Assessment, Other: Questionnaire Administration, Radiation: Radiation TherapyPatients receive cetuximab IV over 120 minutes 5-7 days prior to start of radiation therapy and then IV over 60 minutes weekly on Monday or Tuesday for 7 weeks. Patients also undergo radiation therapy and receive cisplatin as in Arm I. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (16 listed)
- Written informed consent obtained from the patient/legal representative prior to performing any protocol-related procedures, including screening evaluation
- Newly diagnosed, untreated, biopsy-proven HPV+ squamous cell carcinoma of the oropharynx. Cytologic diagnosis from a cervical lymph node is sufficient in the presence of clinical evidence of a primary tumor in the oropharynx. Clinical evidence should be documented, may consist of palpation, imaging, or endoscopic evaluation and should be sufficient to estimate the size of the primary (for T stage). HPV-positivity will be defined as tumors that are p16-positive by immunohistochemistry
- Selective stage III-IV disease (T3-T4 or N2-N3 disease) by American Joint Committee on Cancer (AJCC) 8th edition as determined by a computed tomography (CT) scan or magnetic resonance imaging (MRI) of the head and neck, CT neck, chest, abdomen, pelvis or a PET =< 6 weeks of registration
- Confirmation of KRAS-variant status as assessed by genotyping from a cheek swab sample at MiraDx
- Lifetime cumulative smoking history of < 10 pack-years. The cumulative total of the number of pack-years during each period of active smoking is the lifetime cumulative history
Key exclusion criteria (18 listed)
- Patients with biopsy-proven metastatic, HPV-negative, KRAS-variant negative, or recurrent head and neck squamous cell carcinoma (HNSCC)
- Patients with primary site of tumor outside of the oropharynx, specifically of the oral cavity, salivary glands, nasal cavity, paranasal sinuses, larynx, hypopharynx, or nasopharynx
- Patients with prior radiation therapy (RT) that would result in overlap of radiation therapy treatment fields (superficial x-ray of skin lesions excluded)
- Gross total excision (ex. tonsillectomy) of the primary tumor; however, partial removal of the tumor to alleviate an impending airway obstruction does not make the patient ineligible. Initial surgical treatment, excluding diagnostic biopsy of the primary site or nodal sampling of neck disease, as well as radical or modified neck dissection is not permitted
- Prior systemic chemotherapy or biologic therapy for the study cancer; note that prior chemotherapy or biologic therapy for a different cancer is allowable
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 |
|---|---|---|
| CetuximabAlso: Cetuximab Biosimilar CDP-1, Cetuximab Biosimilar CMAB009, Cetuximab Biosimilar KL 140, Chimeric Anti-EGFR Monoclonal AntibodyGiven IV | Biological | Arm II (cetuximab, radiation therapy, cisplatin) |
| CisplatinAlso: Abiplatin, Blastolem, Briplatin, CDDPGiven IV | Drug | Arm I (radiation therapy, cisplatin), Arm II (cetuximab, radiation therapy, cisplatin) |
| Quality-of-Life AssessmentAlso: Quality of Life AssessmentAncillary studies | Other | Arm I (radiation therapy, cisplatin), Arm II (cetuximab, radiation therapy, cisplatin) |
| Questionnaire AdministrationAncillary studies | Other | Arm I (radiation therapy, cisplatin), Arm II (cetuximab, radiation therapy, cisplatin) |
| Radiation TherapyAlso: Cancer Radiotherapy, Irradiate, Irradiated, irradiationUndergo radiation therapy | Radiation | Arm I (radiation therapy, cisplatin), Arm II (cetuximab, radiation therapy, cisplatin) |
Primary outcome
Overall survival (OS)
Time frame: From time of randomization to death due to any cause, assessed at 2 years
OS will be estimated in each study arm by Kaplan-Meier estimate. Summaries of the number and percentage of patients who have died, are still in survival follow-up, are lost to follow-up and have withdrawn consent will be provided along with median OS. Furthermore, a binomial test of proportions will be used to test difference in 2-year OS between the two arms. Exact tests and continuity correction strategies will be considered when appropriate.
4 secondary outcomes
Primary tumor control
Time frame: Up to 5 years
Locoregional recurrence rate
Time frame: Up to 5 years
Acute toxicity
Time frame: Up to 5 years
Late toxicity
Time frame: Up to 5 years
Results and safety
The study was stopped early (reason given: low enrollment). Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 1 Jun 2023.
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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.
Robert K Chin principal investigator
UCLA / Jonsson Comprehensive Cancer Center
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 Cetuximab, Cisplatin and Quality-of-Life Assessment in people with Clinical Stage III HPV-Mediated (p16-Positive) Oropharyngeal Carcinoma AJCC v8 and Clinical Stage IV HPV-Mediated (p16-Positive) Oropharyngeal Carcinoma AJCC v8, run by Jonsson Comprehensive Cancer Center 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 16 inclusion and 18 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: stopped early, as of the sponsor's last update on 1 Jun 2023. 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?
The study was stopped early (reason given: low enrollment). Results are not available in the source record.
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?
Overall survival (OS) (time frame: From time of randomization to death due to any cause, assessed at 2 years). 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 1 Jun 2023.