Cancer of the Head and NeckPhase 2ENIDNCT04444869
Testing Less Intensive Radiation With Chemotherapy to Treat Low-risk Patients With HPV-positive Oropharyngeal Cancer
A Phase 2 study testing Cisplatin injection in people with Cancer of the Head and Neck and Oropharynx Cancer, run by University of Missouri-Columbia at 1 site in United States.
Trial summary
This trial will explore giving standard dose chemotherapy and radiation therapy to sites of disease including all lymph nodes involved with HPV-positive oropharyngeal cancer, but administer lower doses of radiation therapy to the lymph nodes that are not known to be involved with cancer. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Cancer of the Head and Neck, Oropharynx Cancer, HPV Positive Oropharyngeal Squamous Cell Carcinoma
- What is being tested?
- Cisplatin injection
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 28 participants
- Where
- 1 siteUnited States
- Study dates
- 28 Sep 2020to Jun 2026
- 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
- Patients generally must have the psychological ability and general health that permits completion of the study requirements and required follow up.
- Women of childbearing potential and men who are sexually active should be willing and able to use medically acceptable forms of contraception throughout the treatment phase of the trial and until at least 60 days following the last study treatment.
- Pathologically (histologically or cytologically) proven diagnosis of squamous cell carcinoma (including the histological variants papillary squamous cell carcinoma and basaloid squamous cell carcinoma) of the oropharynx (tonsil, base of tongue, soft palate, or oropharyngeal walls); 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).
- Patients must have clinically or radiographically evident measurable disease at the primary site or at nodal stations. Tonsillectomy or local excision of the primary without removal of nodal disease is permitted, as is excision removing gross nodal disease but with intact primary site. Limited neck dissections retrieving ≤ 4 nodes are permitted and considered as non-therapeutic nodal excisions.
- Immunohistochemical staining for p16 must be performed on tissue and documented in the pathology report(s) with reported result positive for p16.
- Clinical stage T1-T3, N0-N2c (AJCC, 7th ed.), which is equal to T1-T3, N0-2 (AJCC, 8th ed.) including no distant metastases based on the following diagnostic workup:
Show all 27Show fewer
- General history and physical examination within 30 days prior to registration;
- Fiberoptic exam with laryngopharyngoscopy (mirror and/or fiberoptic and/or direct procedure) within 60 days prior to registration;
- One of the following combinations of imaging is required within 45 days prior to registration:
- A CT scan of the neck (with contrast) and a chest CT scan (with or without contrast);
- or an MRI of the neck (with contrast) and a chest CT scan (with or without contrast);
- or a CT scan of neck (with contrast) and a PET/CT of neck and chest (with or without contrast);
- or an MRI of the neck (with contrast) and a PET/CT of neck and chest (with or without contrast).
- Note: A CT scan of neck and/or a PET/CT performed for the purposes of radiation planning may serve as both staging and planning tools.
- Patients will be asked about their personal smoking history prior to enrollment. Only active smokers with greater than 10 pack years will be excluded from the trial. The total number of pack years will be collected at baseline. Current smokers who wish to discontinue will be offered smoking cessation information, and if they are able to discontinue smoking prior to initiation of radiation therapy, they can remain eligible for the trial.
- Number of pack-years = [Frequency of smoking (number of cigarettes per day) × duration of cigarette smoking (years)] / 20 Note: Twenty cigarettes is considered equivalent to one pack. The effect of non-cigarette tobacco products on the survival of patients with p16-positive oropharyngeal cancers is undefined.
- Zubrod Performance Status of 0-1 within 30 days prior to registration;
- Adequate hematologic function within 14 days prior to registration, defined as follows:
- Absolute neutrophil count (ANC) ≥ 1,500 cells/mm3;
- Platelets ≥ 100,000 cells/mm3;
- Hemoglobin ≥ 8.0 g/dl; Note: The use of transfusion or other intervention to achieve Hgb ≥ 8.0 g/dl is acceptable.
- Adequate renal function within 14 days prior to registration, defined as follows:
- Serum creatinine < 1.5 mg/dl or creatinine clearance (CC) ≥ 50 ml/min
- Adequate hepatic function within 14 days prior to registration defined as follows:
- Bilirubin < 2 mg/dl;
- AST or ALT < 3 x the upper limit of normal.
- Negative serum pregnancy test within 14 days prior to registration for women of childbearing potential
Who cannot join
- Cancers considered to be from an oral cavity site (oral tongue, floor mouth, alveolar ridge, buccal or lip), or the nasopharynx, hypopharynx, or larynx, even if p16 positive;
- Carcinoma of the neck of unknown primary site origin (even if p16 positive);
- T1-T2 N0-1 lateralized squamous cell carcinoma of the tonsil.
- Radiographically matted nodes, that span 6 cm or more; N3 disease
- Supraclavicular nodes, defined as nodes visualized on the same axial imaging slice as the clavicle;
- Definitive clinical or radiologic evidence of metastatic disease or adenopathy below the clavicles;
Show all 17Show fewer
- Gross total excision of both primary and nodal disease; this includes tonsillectomy, local excision of primary site, and nodal excision that removes all clinically and radiographically evident disease.
- Simultaneous primary cancers or separate bilateral primary tumor sites;
- Prior invasive malignancy (except non-melanomatous skin cancer) unless disease free for a minimum of 5 years (for example, carcinoma in situ of the breast, oral cavity, or cervix are all permissible);
- Prior systemic chemotherapy for the study cancer; note that prior chemotherapy for a different cancer is allowable;
- Prior radiotherapy to the region of the study cancer that would result in overlap of radiation therapy fields;
- Severe, active co-morbidity defined as follows:
- Unstable angina and/or congestive heart failure requiring hospitalization within the last 6 months;
- Transmural myocardial infarction within the last 6 months;
- Acute bacterial or fungal infection requiring intravenous antibiotics at the time of registration;
- Chronic Obstructive Pulmonary Disease exacerbation or other respiratory illness requiring hospitalization or precluding study therapy within 30 days of registration;
- Hepatic insufficiency resulting in clinical jaundice and/or coagulation defects; note, however, that laboratory tests for liver function and coagulation parameters are not required for entry into this protocol other than those requested in Section 3.2.11 of the protocol.
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
United States1 site, 1 recruiting
- Recruiting
University of Missouri
Columbia, Missouri, 65203
Gregory Biedermann, MD, 573-884-8264, biedermanng@health.missouri.edu
Ken Baker, RN, (573) 884-6479, bakerrk@health.missouri.edu
About this study
Official title: Phase II Trial of Definitive Chemoradiation With Elective Nodal Irradiation Dose De-escalation for p16 Positive Squamous Cell Carcinoma of the Oropharynx "ENID"
This trial will explore giving standard dose chemotherapy and radiation therapy to sites of disease including all lymph nodes involved with HPV-positive oropharyngeal cancer, but administer lower doses of radiation therapy to the lymph nodes that are not known to be involved with cancer. By doing so, it is hypothesized that there will be equally good long term loco-regional and distant disease control but will reduced long term treatment side effects and improved quality of life in persons living well beyond their cancer treatment.
Read the detailed description
This is a trial of definitive chemotherapy and radiation therapy in human papilloma virus positive oropharyngeal cancers, in a population whose cancer is thought to be highly radio-sensitive. This is a population whose outcomes are already known to be very good with high rates of local and distant control of the disease. With the long term disease control and survival of patients with this disease, long term treatment toxicity and resulting reduction in quality of life poses new problems. This has lead to several studies to examine the role of radiation dose de-escalation through various strategies in attempt to reduce long term toxicity from treatment and yet achieve equivalent long term disease control.
This trial specifically hypothesizes that a lower dose of radiation therapy to the clinically and radiographically uninvolved lymph nodes will no detrimental effect on loco-regional control or overall survival and will improve the long-term side effect profile, particularly with regards to xerostomia and dysphagia. The goal of this study is therefore to determine whether a lower dose to the clinically and radiographically uninvolved lymph nodes can be done safely and with better long-term toxicity profile and better overall quality of life without compromising the expected outcomes of progression free survival.
- Conditions
- Cancer of the Head and Neck, Oropharynx Cancer, HPV Positive Oropharyngeal Squamous Cell Carcinoma, Throat Carcinoma
- Being tested
- Cisplatin injection
- Medical subject headings
- Head and Neck Neoplasms, Oropharyngeal Neoplasms
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Cisplatin injectionDrug
Standard dose cisplatin given concurrently with radiation therapy
| Study group | Role | What they receive |
|---|---|---|
| Open label single-arm study | Other | All patients will receive concurrent cisplatin and radiation therapy with radiation dose de-escalation to clinically and radiologically uninvolved lymph nodes. Receives: Drug: Cisplatin injection |
What is being measured
The primary outcome is the main question the study is designed to answer.
Rate of PEG tube placement
To determine rate of PEG tube placement
Measured: During the procedure
Secondary outcomes (6)
Progression-free survival
Progression-free survival of 85% or more at measured a 2 years post treatment
Measured: Two years post treatment
Dysphagia index
To report the change in dysphagia using the M. D. Anderson Dysphagia Inventory (MDADI) scores. Scores are 0 (lowest functioning) to 100 (highest functioning).
Measured: Baseline, 1 month and 6 months after treatment
Patient Reported Outcomes
European Organisation for Research and Treatment of Cancer (EORTC) Quality of Life Questionnaire
Measured: Baseline and 1, 6, and 12 months after end of treatment
Survival
To determine overall survival and progression-free survival
Measured: At 6 months and at 2 years
Toxicity profiles
Incidence of Common Terminology Criteria for Adverse Events (CTCAE) grade 2 or higher for mucositis, dysphagia, xerostomia and altered taste
Measured: 1 year and 2 years post treatment
Hypothyroidism incidence
To monitor rate of hypothyroidism
Measured: At 1 and 2 years post treatment
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted24 Jun 2020
- Study start28 Sep 2020
- Primary completionJun 2025 (estimated)
- Study completionJun 2026 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Cancer of the Head and NeckStudies of the same condition, open and under way.
- More trials run by University of Missouri-ColumbiaThe 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
- Not applicable
- Intervention model
- Single group
- Model description
- All patients are treated with the same approach.
- Masking
- None (open label)
- Enrolment
- 28 participants (estimated)
Sponsor and investigators
- Lead sponsor
- University of Missouri-Columbia
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Gregory Biedermann, University of Missouri-Columbia
- Investigators
- Gregory Biedermann, MD, Principal investigator, University of Missouri - Ellis Fischel Cancer Center
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04444869
- Sponsor's protocol ID
- 2017520
- Acronym
- ENID
- Status last verified
- May 2024
- First submitted
- 28 May 2020
- Last updated
- 17 May 2024
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- Yes
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 17 May 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Phase II Trial of Definitive Chemoradiation With Elective Nodal Irradiation Dose De-escalation for p16 Positive Squamous Cell Carcinoma of the Oropharynx "ENID"
- ClinicalTrials.gov ID
- NCT04444869
- Acronym / sponsor ID
- ENID / 2017520
- Conditions
- Cancer of the Head and Neck, Oropharynx Cancer, HPV Positive Oropharyngeal Squamous Cell Carcinoma, Throat Carcinoma
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 28 participants (estimated)
- Lead sponsor
- University of Missouri-ColumbiaUniversity, hospital or other
- Study start
- 28 Sep 2020 (actual)
- Primary completion
- Jun 2025 (estimated)
- Study completion
- Jun 2026 (estimated)
- First posted
- 24 Jun 2020 (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 trial will explore giving standard dose chemotherapy and radiation therapy to sites of disease including all lymph nodes involved with HPV-positive oropharyngeal cancer, but administer lower doses of radiation therapy to the lymph nodes that are not known to be involved with cancer. By doing so, it is hypothesized that there will be equally good long term loco-regional and distant disease control but will reduced long term treatment side effects and improved quality of life in persons living well beyond their cancer treatment.
Detailed description
This is a trial of definitive chemotherapy and radiation therapy in human papilloma virus positive oropharyngeal cancers, in a population whose cancer is thought to be highly radio-sensitive. This is a population whose outcomes are already known to be very good with high rates of local and distant control of the disease. With the long term disease control and survival of patients with this disease, long term treatment toxicity and resulting reduction in quality of life poses new problems. This has lead to several studies to examine the role of radiation dose de-escalation through various strategies in attempt to reduce long term toxicity from treatment and yet achieve equivalent long term disease control.
This trial specifically hypothesizes that a lower dose of radiation therapy to the clinically and radiographically uninvolved lymph nodes will no detrimental effect on loco-regional control or overall survival and will improve the long-term side effect profile, particularly with regards to xerostomia and dysphagia. The goal of this study is therefore to determine whether a lower dose to the clinically and radiographically uninvolved lymph nodes can be done safely and with better long-term toxicity profile and better overall quality of life without compromising the expected outcomes of progression free survival.
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
- Model description
- All patients are treated with the same approach.
| Arm | Type | Receives |
|---|---|---|
| Open label single-arm study | Other | Drug: Cisplatin injectionAll patients will receive concurrent cisplatin and radiation therapy with radiation dose de-escalation to clinically and radiologically uninvolved lymph nodes. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (27 listed)
- Patients generally must have the psychological ability and general health that permits completion of the study requirements and required follow up.
- Women of childbearing potential and men who are sexually active should be willing and able to use medically acceptable forms of contraception throughout the treatment phase of the trial and until at least 60 days following the last study treatment.
- Pathologically (histologically or cytologically) proven diagnosis of squamous cell carcinoma (including the histological variants papillary squamous cell carcinoma and basaloid squamous cell carcinoma) of the oropharynx (tonsil, base of tongue, soft palate, or oropharyngeal walls); 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).
- Patients must have clinically or radiographically evident measurable disease at the primary site or at nodal stations. Tonsillectomy or local excision of the primary without removal of nodal disease is permitted, as is excision removing gross nodal disease but with intact primary site. Limited neck dissections retrieving ≤ 4 nodes are permitted and considered as non-therapeutic nodal excisions.
- Immunohistochemical staining for p16 must be performed on tissue and documented in the pathology report(s) with reported result positive for p16.
Key exclusion criteria (17 listed)
- Cancers considered to be from an oral cavity site (oral tongue, floor mouth, alveolar ridge, buccal or lip), or the nasopharynx, hypopharynx, or larynx, even if p16 positive;
- Carcinoma of the neck of unknown primary site origin (even if p16 positive);
- T1-T2 N0-1 lateralized squamous cell carcinoma of the tonsil.
- Radiographically matted nodes, that span 6 cm or more; N3 disease
- Supraclavicular nodes, defined as nodes visualized on the same axial imaging slice as the clavicle;
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 |
|---|---|---|
| Cisplatin injectionStandard dose cisplatin given concurrently with radiation therapy | Drug | Open label single-arm study |
Primary outcome
Rate of PEG tube placement
Time frame: During the procedure
To determine rate of PEG tube placement
6 secondary outcomes
Progression-free survival
Time frame: Two years post treatment
Dysphagia index
Time frame: Baseline, 1 month and 6 months after treatment
Patient Reported Outcomes
Time frame: Baseline and 1, 6, and 12 months after end of treatment
Survival
Time frame: At 6 months and at 2 years
Toxicity profiles
Time frame: 1 year and 2 years post treatment
Hypothyroidism incidence
Time frame: At 1 and 2 years post treatment
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 17 May 2024.
- Individual participant dataSharing planned: No
Related trials for Cancer of the Head and Neck
RecruitingPhase 1/2
Study of INBRX-106 and INBRX-106 in Combination With Pembrolizumab (Keytruda®) in Subjects With Locally Advanced or Metastatic Solid Tumors (Hexavalent OX40 Agonist)
Solid Tumor, Non-Small Cell Lung Cancer
RecruitingObservational study
Proton Re-irradiation in Patients With Recurrent or Second Primary Head and Neck Cancer , a Multicentre Phase II Single Arm Trial
Head & Neck Cancer
RecruitingPhase 2
Proton Spatially Fractionated Radiotherapy or Photon Stereotactic Body Radiotherapy in Combination With Pembrolizumab Before Surgery for the Treatment of Locally Advanced and Radiation-Naive Locoregionally Recurrent Oral Cavity Cancer, OSPRI Trial
Locally Advanced Oral Cavity Squamous Cell Carcinoma, Locally Recurrent Oral Cavity Squamous Cell Carcinoma
RecruitingPhase 4
Lidocaine Infiltration and Neuroimmunomodulation in Head and Neck Cancer Surgery
Head and Neck Cancer (H&N)
RecruitingObservational study
A Study of Neurocognitive Tests and Questionnaires for People With Head and Neck Cancer Who Are Undergoing Radiation Therapy
Head and Neck Cancer
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.
Gregory Biedermann, MD principal investigator
University of Missouri - Ellis Fischel 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 Cisplatin injection in people with Cancer of the Head and Neck and Oropharynx Cancer, run by University of Missouri-Columbia 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 27 inclusion and 17 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 17 May 2024. 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 Gregory Biedermann, MD ((573) 884-8264, biedermanng@health.missouri.edu), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Rate of PEG tube placement (time frame: During the procedure). 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 17 May 2024.