HPV-Mediated (P16-Positive) Oropharyngeal Carcinoma by AJCC V8 Clinical StageNCT04638465
De-Escalation Protocol Of HPV Mediated Oropharyngeal Squamous Cell Carcinoma
An observational study of HPV-Mediated (P16-Positive) Oropharyngeal Carcinoma by AJCC V8 Clinical Stage and Oropharynx Cancer, run by Nebraska Methodist Health System at 1 site in United States.
Trial summary
The purpose of this study is to evaluate the effects, good and/or bad, of treating participants with HPV-mediated oropharyngeal cancer, with less treatment, using the new staging system. The investigators believe this treatment will provide the same effectiveness as the usual treatment, but decrease the side effects. Read more about this study
- Who is it for?
- Ages 19 years and older
- Conditions the study is for
- HPV-Mediated (P16-Positive) Oropharyngeal Carcinoma by AJCC V8 Clinical Stage, Oropharynx Cancer
- What is being tested?
- Transoral robotic surgery, Cisplatin - Dose Level 1 and Cisplatin - Dose Level 2
- Type of treatment
- Surgery or procedure
- How many people
- 150 participants
- Where
- 1 siteUnited States
- Study dates
- 6 Aug 2018to Jan 2030
- Phase
- Observational
- 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 19 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Study population: Participants must have newly diagnosed, histologically, or cytologically confirmed HPV positive, squamous cell carcinoma of the base of tongue, tonsil, oropharyngeal cavity or unknown primary. Participants must have tumors staged using AJCC TNM 8th edition Staging for Head and Neck cancers.
Who may be able to join
- Participants must have newly diagnosed, histologically, or cytologically confirmed HPV positive, squamous cell carcinoma of the base of tongue, tonsil, oropharyngeal cavity or unknown primary.
- Participants must have tumors staged using AJCC TNM 8th edition Staging for Head and Neck cancers.
- Participants must have an exam by a Head and Neck Oncologist within 6 weeks before registration.
- Participants must not have any evidence of distant metastatic disease.
- Participants with other active malignancies may be eligible, at the discretion of the investigator, as long as the treatment plan for the head and neck cancer outlined in this protocol can still be followed. The potential effect of the treatment and disease progress of the second active malignancy should also have minimal or no impact on the toxicities being monitored on this study.
- Participants must not have any uncontrolled intercurrent illnesses, psychiatric illnesses, psychosocial problems, or social situations that would limit the patient's compliance with the study or ability to successfully complete the study treatment safely.
- Participants with inconclusive pathology after biopsy; who are found to have HPV positive SCC following standard of care surgery are eligible to enroll.
- Participants who require additional surgery to complete staging with known HPV+ SCC are eligible to enroll.
Who cannot join
- Participants must not be receiving or planning to receive any other clinical trial therapy or intervention.
- Participants with an unknown primary tumor who are both HPV positive and EBV positive are NOT eligible for this protocol.
- These additional evaluations must be performed on participants with T0 (unknown primary site) P16+ squamous cell carcinoma of the head and neck prior to registration.
- Flexible laryngoscope
- Ultrasound guided Fine-needle aspirate (FNA) of the known site of disease with the following analysis:
- Human papilloma virus (HPV); p16 Immuno-Histo-Chemical Staining. If negative, complete high risk HPV Fluorescence in-situ Hybridization (FISH).
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- Epstein Barr Virus (EBV): Epstein Barr Virus Encoded RNA (EBER) in-situ Hybridization.
- Direct Laryngoscopy with directed biopsy of bilateral base of tongue, bilateral palatine tonsillectomy, and dental extraction, as needed.
- If a participant is both HPV positive and EBV positive, he/she is not eligible.
Trial locations and contacts
1 site in 1 country.
About this study
Official title: De-Escalation Protocol Of HPV Mediated Oropharyngeal Squamous Cell Carcinoma Based On The AJCC 8th Edition Staging Manual
The purpose of this study is to evaluate the effects, good and/or bad, of treating participants with HPV-mediated oropharyngeal cancer, with less treatment, using the new staging system. The investigators believe this treatment will provide the same effectiveness as the usual treatment, but decrease the side effects. The radiation doses, chemotherapy doses, and the type of surgical approaches that will be used in this treatment protocol have all been previously investigated. Previous research suggests that this can be done safely, but there has not been a study done basing treatment on the new staging system.
- Conditions
- HPV-Mediated (P16-Positive) Oropharyngeal Carcinoma by AJCC V8 Clinical Stage, Oropharynx Cancer
- Being tested
- Transoral robotic surgery, Cisplatin - Dose Level 1, Cisplatin - Dose Level 2, Dose Level 1, Dose Level 2
- Keywords
- HPV-Mediated, Oropharyngeal Cancer, P16-Positive
- Medical subject headings
- Oropharyngeal Neoplasms
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Transoral robotic surgeryProcedure or surgery
Transoral resection with neck dissection
Cisplatin - Dose Level 1Drug
6 Cycles of 40 mg/m2
Cisplatin - Dose Level 2Drug
7 Cycles of 40 mg/m2
Dose Level 1Radiation
60 Gy/6 weeks - 2 Gy/fraction, 5 fractions/week
Dose Level 2Radiation
70 Gy/7 weeks - 2 Gy/fraction, 5 fractions/week
| Study group | Role | What they receive |
|---|---|---|
| A - Surgery Only | Participants with the following diagnosis will receive transoral robotic surgery with neck dissection:
* Base of Tongue/Non-Tonsil Oropharynx - Stage: cT1-2, cN0 or N1 (single node)
* Tonsil - Stage: cT1-3, cN0 or N1 (single node)
* Unknown primary - Stage: cT0 N1 (single node)
Radiation also given if indicated by intermediate or high risk features following surgery. Receives: Procedure: Transoral robotic surgery | |
| B - Surgery with Adjuvant Therapy | Participants with the following diagnosis will receive surgery followed by 6 Cycles of Cisplatin 40 mg/m2:
* Base of Tongue/Non-Tonsil Oropharynx - Stage: cT1-2, cN1 (2-4 nodes) or N2
* Tonsil - Stage: cT1-3, N1 (2-4 nodes)
Radiation also given if indicated by intermediate or high risk features following surgery. Receives: Procedure: Transoral robotic surgery; Drug: Cisplatin - Dose Level 1 | |
| C - Concurrent Chemo/Radiation Therapy - Dose Level 1 | Participants with the following diagnosis will receive 6 Cycles of Cisplatin 40 mg/m2 + 60 Gy Radiation:
* Tonsil - Stage: cT1-3, N2
* Unknown Primary - Stage: cT0, N2 Receives: Drug: Cisplatin - Dose Level 1; Radiation: Dose Level 1 | |
| D - Concurrent Chemo/Radiation Therapy - Dose Level 2 | Participants with the following diagnosis will receive 7 Cycles of Cisplatin 40 mg/m2 + 70 Gy Radiation:
* Base of Tongue/Non-Tonsil Oropharynx - Stage: cT3-4, any N
* Base of Tongue/Non-Tonsil Oropharynx - Stage: cAny T, N3
* Tonsil - Stage: cT1-3, N3
* Tonsil - Stage: cT4, any N
* Unknown Primary - Stage: cT0, N3 Receives: Drug: Cisplatin - Dose Level 2; Radiation: Dose Level 2 |
What is being measured
The primary outcome is the main question the study is designed to answer.
Overall survival
To determine if overall survival remains the same with the de-escalated protocol as the historical standard of care survival benefit.
Measured: From randomization to death, assessed up to 10 years
Disease Free Survival
To determine if disease free survival remains the same with the de-escalated protocol as the historical standard of care survival benefit.
Measured: From randomization to date of progression, second primary tumor from the head and neck region, or death, assessed up to 10 years
Secondary outcomes (3)
Rate of Patients with a Grade 3 or Higher Adverse Event
To evaluate the side effects patients experience when being treated on the de-escalated protocol.
Measured: From randomization to death, assessed up to 10 years
Measure the quality of life of participants using the FACT H&N assessment tool
To evaluate the quality of life of patients who are treated with the de-escalated protocol.
Measured: From randomization to death, assessed up to 10 years
Measure the depression of participants using the Self-Report Quick Inventory of Depressive Symptomatology assessment
To evaluate depression in patients who are treated with the de-escalated protocol.
Measured: From randomization to death, assessed up to 10 years
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted20 Nov 2020
- Study start6 Aug 2018
- Primary completionJan 2025 (estimated)
- Study completionJan 2030 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for HPV-Mediated (P16-Positive) Oropharyngeal Carcinoma by AJCC V8 Clinical StageStudies 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
- Observational
- Observational model
- Cohort
- Time perspective
- Prospective
- Enrolment
- 150 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Nebraska Methodist Health System
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04638465
- Sponsor's protocol ID
- MECC-HN01
- Status last verified
- Apr 2023
- First submitted
- 11 Nov 2020
- Last updated
- 9 Nov 2023
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- Yes
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
Panwar A, Shah S, Reid AE, Lydiatt W, Holcomb AJ, Osmolak A, Coughlin A, Militsakh O, Su YB, Mirmiran A, Huang TS, Nolan N, Duckert R, Barney C, Chiu M, Nguyen C, Sayles H, Ganti AK, Lindau R. Quality of Life and Depression Symptoms After Therapy De-Escalation in HPV+ Oropharyngeal Squamous Cell Carcinoma: A Nonrandomized Controlled Trial. JAMA Otolaryngol Head Neck Surg. 2024 May 1;150(5):429-435. doi: 10.1001/jamaoto.2024.0262.
PubMed 38573597
Study at a glance
From the registry record, last updated by the sponsor on 9 Nov 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- De-Escalation Protocol Of HPV Mediated Oropharyngeal Squamous Cell Carcinoma Based On The AJCC 8th Edition Staging Manual
- ClinicalTrials.gov ID
- NCT04638465
- Acronym / sponsor ID
- MECC-HN01
- Conditions
- HPV-Mediated (P16-Positive) Oropharyngeal Carcinoma by AJCC V8 Clinical Stage, Oropharynx Cancer
- Keywords
- HPV-Mediated, Oropharyngeal Cancer, P16-Positive
- Study type
- Observational
- Recruitment status
- Active, not recruiting
- Enrolment
- 150 participants (estimated)
- Lead sponsor
- Nebraska Methodist Health SystemUniversity, hospital or other
- Study start
- 6 Aug 2018 (actual)
- Primary completion
- Jan 2025 (estimated)
- Study completion
- Jan 2030 (estimated)
- First posted
- 20 Nov 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.
The purpose of this study is to evaluate the effects, good and/or bad, of treating participants with HPV-mediated oropharyngeal cancer, with less treatment, using the new staging system. The investigators believe this treatment will provide the same effectiveness as the usual treatment, but decrease the side effects. The radiation doses, chemotherapy doses, and the type of surgical approaches that will be used in this treatment protocol have all been previously investigated. Previous research suggests that this can be done safely, but there has not been a study done basing treatment on the new staging system.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
- Number of arms
- 4
| Arm | Type | Receives |
|---|---|---|
| A - Surgery Only | – | Procedure: Transoral robotic surgeryParticipants with the following diagnosis will receive transoral robotic surgery with neck dissection: * Base of Tongue/Non-Tonsil Oropharynx - Stage: cT1-2, cN0 or N1 (single node) * Tonsil - Stage: cT1-3, cN0 or N1 (single node) * Unknown primary - Stage: cT0 N1 (single node) Radiation also given if indicated by intermediate or high risk features following surgery. |
| B - Surgery with Adjuvant Therapy | – | Procedure: Transoral robotic surgery, Drug: Cisplatin - Dose Level 1Participants with the following diagnosis will receive surgery followed by 6 Cycles of Cisplatin 40 mg/m2: * Base of Tongue/Non-Tonsil Oropharynx - Stage: cT1-2, cN1 (2-4 nodes) or N2 * Tonsil - Stage: cT1-3, N1 (2-4 nodes) Radiation also given if indicated by intermediate or high risk features following surgery. |
| C - Concurrent Chemo/Radiation Therapy - Dose Level 1 | – | Drug: Cisplatin - Dose Level 1, Radiation: Dose Level 1Participants with the following diagnosis will receive 6 Cycles of Cisplatin 40 mg/m2 + 60 Gy Radiation: * Tonsil - Stage: cT1-3, N2 * Unknown Primary - Stage: cT0, N2 |
| D - Concurrent Chemo/Radiation Therapy - Dose Level 2 | – | Drug: Cisplatin - Dose Level 2, Radiation: Dose Level 2Participants with the following diagnosis will receive 7 Cycles of Cisplatin 40 mg/m2 + 70 Gy Radiation: * Base of Tongue/Non-Tonsil Oropharynx - Stage: cT3-4, any N * Base of Tongue/Non-Tonsil Oropharynx - Stage: cAny T, N3 * Tonsil - Stage: cT1-3, N3 * Tonsil - Stage: cT4, any N * Unknown Primary - Stage: cT0, N3 |
Who may qualify
- Ages
- 19 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- Participants must have newly diagnosed, histologically, or cytologically confirmed HPV positive, squamous cell carcinoma of the base of tongue, tonsil, oropharyngeal cavity or unknown primary. Participants must have tumors staged using AJCC TNM 8th edition Staging for Head and Neck cancers.
Key inclusion criteria (8 listed)
- Participants must have newly diagnosed, histologically, or cytologically confirmed HPV positive, squamous cell carcinoma of the base of tongue, tonsil, oropharyngeal cavity or unknown primary.
- Participants must have tumors staged using AJCC TNM 8th edition Staging for Head and Neck cancers.
- Participants must have an exam by a Head and Neck Oncologist within 6 weeks before registration.
- Participants must not have any evidence of distant metastatic disease.
- Participants with other active malignancies may be eligible, at the discretion of the investigator, as long as the treatment plan for the head and neck cancer outlined in this protocol can still be followed. The potential effect of the treatment and disease progress of the second active malignancy should also have minimal or no impact on the toxicities being monitored on this study.
Key exclusion criteria (9 listed)
- Participants must not be receiving or planning to receive any other clinical trial therapy or intervention.
- Participants with an unknown primary tumor who are both HPV positive and EBV positive are NOT eligible for this protocol.
- These additional evaluations must be performed on participants with T0 (unknown primary site) P16+ squamous cell carcinoma of the head and neck prior to registration.
- Flexible laryngoscope
- Ultrasound guided Fine-needle aspirate (FNA) of the known site of disease with the following analysis:
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 |
|---|---|---|
| Transoral robotic surgeryTransoral resection with neck dissection | Procedure or surgery | A - Surgery Only, B - Surgery with Adjuvant Therapy |
| Cisplatin - Dose Level 16 Cycles of 40 mg/m2 | Drug | B - Surgery with Adjuvant Therapy, C - Concurrent Chemo/Radiation Therapy - Dose Level 1 |
| Cisplatin - Dose Level 27 Cycles of 40 mg/m2 | Drug | D - Concurrent Chemo/Radiation Therapy - Dose Level 2 |
| Dose Level 160 Gy/6 weeks - 2 Gy/fraction, 5 fractions/week | Radiation | C - Concurrent Chemo/Radiation Therapy - Dose Level 1 |
| Dose Level 270 Gy/7 weeks - 2 Gy/fraction, 5 fractions/week | Radiation | D - Concurrent Chemo/Radiation Therapy - Dose Level 2 |
Primary outcome
Overall survival
Time frame: From randomization to death, assessed up to 10 years
To determine if overall survival remains the same with the de-escalated protocol as the historical standard of care survival benefit.
Disease Free Survival
Time frame: From randomization to date of progression, second primary tumor from the head and neck region, or death, assessed up to 10 years
To determine if disease free survival remains the same with the de-escalated protocol as the historical standard of care survival benefit.
3 secondary outcomes
Rate of Patients with a Grade 3 or Higher Adverse Event
Time frame: From randomization to death, assessed up to 10 years
Measure the quality of life of participants using the FACT H&N assessment tool
Time frame: From randomization to death, assessed up to 10 years
Measure the depression of participants using the Self-Report Quick Inventory of Depressive Symptomatology assessment
Time frame: From randomization to death, assessed up to 10 years
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 9 Nov 2023.
- Derived from this study: PubMed 38573597Panwar A, Shah S, Reid AE, Lydiatt W, Holcomb AJ, Osmolak A, Coughlin A, Militsakh O, Su YB, Mirmiran A, Huang TS, Nolan N, Duckert R, Barney C, Chiu M, Nguyen C, Sayles H, Ganti AK, Lindau R. Quality of Life and Depression Symptoms After Therapy De-Escalation in HPV+ Oropharyngeal Squamous Cell Carcinoma: A Nonrandomized Controlled Trial. JAMA Otolaryngol Head Neck Surg. 2024 May 1;150(5):429-435. doi: 10.1001/jamaoto.2024.0262.
- Individual participant dataSharing planned: No
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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.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of HPV-Mediated (P16-Positive) Oropharyngeal Carcinoma by AJCC V8 Clinical Stage and Oropharynx Cancer, run by Nebraska Methodist Health System 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 8 inclusion and 9 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 9 Nov 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.
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?
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 (time frame: From randomization to death, assessed up to 10 years). The study lists 2 primary outcomes in all. 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 NCT04638465, which also lists 1 linked publication.
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 9 Nov 2023.