HPV-Related Oropharynx Squamous Cell CarcinomaPhase 2MINT-2NCT06702033
The Minimalist Trial-2
A Phase 2 study testing Radiation therapy, Cisplatin and Surgery in people with HPV-Related Oropharynx Squamous Cell Carcinoma, run by Washington University School of Medicine at 3 sites in United States.
Trial summary
Head and neck squamous cell carcinoma (HNSCC) is the sixth most common cancer. Oropharynx SCC (OPSCC) is a common sub-type of HNSCC. Each year, 16,000 new cases of OPSCC are diagnosed in the USA. Most cases of OPSCC (>90%) are caused by the human papillomavirus (HPV) and are often cured with current therapy. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- HPV-Related Oropharynx Squamous Cell Carcinoma
- What is being tested?
- Radiation therapy, Cisplatin and Surgery
- Type of treatment
- Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 142 participants
- Where
- 3 sitesUnited States
- Study dates
- 10 Apr 2025to 15 Jul 2033
- 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
- Histologically or cytologically confirmed HPV-related, clinical stages I-II OPSCC (8th edition of AJCC/UICC Staging Manual) or HPV-related neck node with unknown primary. Clinical T1N0M0 and T2N0M0 disease are excluded. HPV-related may be defined by p16 IHC stain and/or HPV-High Risk RNA ISH/HPV DNA genotyping by PCR, using standard definitions of positive and negative test results.
- Planned resection of the primary tumor site by a transoral approach (TORS, TLM, or conventional surgery).
- Planned unilateral or contralateral selective neck dissection.
- ECOG PS 0-2.
- Adequate organ and marrow function defined as:
- Creatinine clearance ≥ 50 mL/min.
Show all 11Show fewer
- ANC ≥ 1.0 K/cumm.
- Platelet count ≥100 K/cumm.
- At least 18 years of age.
- Women of childbearing potential and men must agree to use adequate contraception (hormonal or barrier method of birth control, abstinence) prior to study entry and for the duration of participation. Should a woman become pregnant or suspect she is pregnant while participating in this study, she must inform her treating physician immediately.
- Ability to understand and willingness to sign an IRB approved written informed consent document. Legally authorized representatives may sign and give informed consent on behalf of study participants.
Who cannot join
- Clinical T1N0M0 or T2N0M0 disease.
- Prior radiation therapy for HNSCC.
- Planned free-flap reconstruction of the resected primary site.
- Cirrhosis with Child-Pugh Score B or C.
- History of prior invasive malignancy diagnosed within 2 years prior to study enrollment; exceptions are malignancies with a low risk of metastasis or death (e.g., expected 5-year OS > 90%) that were treated with curative-intent therapy.
- Receiving any other investigational agents.
- Uncontrolled serious inter-current illness or serious psychiatric illness/social situations that would limit compliance with study requirements.
- Pregnant and/or breastfeeding. A negative serum pregnancy test is required at screening for all female patients of childbearing potential.
Trial locations and contacts
3 sites in 1 country. Contact the study team or a site near you to ask about taking part.
United States3 sites, 3 recruiting
- Recruiting
Sanford Roger Maris Cancer Center
Fargo, North Dakota, 58102
Daniel Almquist, M.D., 701-234-6161
Daniel Almquist, M.D.
- Recruiting
Sanford Cancer Center
Sioux Falls, South Dakota, 57104
Steven Powell, M.D., 605-328-8000
Steven Powell, M.D.
- Recruiting
Washington University School of Medicine
St Louis, Missouri, 63110
Douglas Adkins, M.D., 314-747-8475, dadkins@wustl.edu
Douglas Adkins, M.D.
About this study
Official title: Phase II Trial of Surgery Followed by Risk-Directed Post-Operative Adjuvant Therapy for HPV-Related Oropharynx Squamous Cell Carcinoma: "The Minimalist Trial-2 (MINT-2)"
Head and neck squamous cell carcinoma (HNSCC) is the sixth most common cancer. Oropharynx SCC (OPSCC) is a common sub-type of HNSCC. Each year, 16,000 new cases of OPSCC are diagnosed in the USA. Most cases of OPSCC (>90%) are caused by the human papillomavirus (HPV) and are often cured with current therapy.
However, patients treated with surgery followed by postoperative adjuvant chemotherapy and radiation therapy (POA(C)RT) still experience substantial morbidity. In this highly curable disease, current clinical research interest is focused on investigation of de-escalated therapy, with the goal to reduce treatment-related adverse events (AEs) while maintaining a low recurrence rate.
Read more
In this study, patients with HPV-related OPSCC will undergo resection of the primary tumor site and involved/at-risk regional neck nodes. Based on the pathology report, patients will be assigned to:
- Arm 1 (de-POACRT-42 Gy)
- Arm 2A (de-POART-42 Gy)
- Arm 2B (de-POART-37.8 Gy)
- Arm 2C (de-POACRT-30 Gy).
All patients with high-risk pathology will be assigned to Arm 1 whereas patients with intermediate-risk pathology will be randomized (1:1:1) to Arm 2A, Arm 2B, or Arm 2C. Patients with highest-risk pathology and low-risk pathology will be removed from the trial after surgery and will be advised to pursue standard of care options.
- Being tested
- Radiation therapy, Cisplatin, Surgery
- Keywords
- De-escalation, Adjuvant therapy, Oropharyngeal cancer, Human papillomavirus
- Medical subject headings
- Oropharyngeal Neoplasms
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Radiation therapyRadiation
IMRT or IMPT
CisplatinDrug
Dose of 100 mg/m^2 IVPB over 60 minutes
SurgeryProcedure or surgery
Standard of care
| Study group | Role | What they receive |
|---|---|---|
| Arm 1: Radiation therapy + Cisplatin | Experimental | * Standard of care surgery will occur before adjuvant therapy.
* It is recommended that radiation therapy begin within 28 to 49 days (and no later than 56 days).
* The total dose to the postoperative tumor bed will be 4200 cGy in 21 fractions of 200 cGy each over 4 weeks.
* Additional regions in the ipsilateral and contralateral neck at risk for microscopic disease in the cervical lymph nodes will receive 3780 cGy in 21 fractions of 180 cGy each.
* Cisplatin will be given on the same day as one of the initial 5 doses of radiation therapy. Receives: Radiation: Radiation therapy; Drug: Cisplatin; Procedure: Surgery |
| Arm 2A: Radiation therapy | Experimental | * Standard of care surgery will occur before adjuvant therapy.
* It is recommended that radiation therapy begin within 28 to 49 days (and no later than 56 days).
* The total dose to the postoperative tumor bed will be 4200 cGy in 21 fractions of 200 cGy each over 4 weeks.
* Additional regions in the ipsilateral and contralateral neck at risk for microscopic disease in the cervical lymph nodes will receive 3780 cGy in 21 fractions of 180 cGy each. Receives: Radiation: Radiation therapy; Procedure: Surgery |
| Arm 2B: Radiation therapy | Experimental | * Standard of care surgery will occur before adjuvant therapy.
* It is recommended that radiation therapy begin within 28 to 49 days (and no later than 56 days).
* The total dose to the postoperative tumor bed will be 3780 cGY in 21 fractions of 180 cGy each over 4 weeks.
* Additional regions in the ipsilateral and contralateral neck at risk for microscopic disease in the cervical lymph nodes will receive 3360 cGy in 21 fractions of 160 cGy each. Receives: Radiation: Radiation therapy; Procedure: Surgery |
| Arm 2C: Radiation therapy + Cisplatin | Experimental | * Standard of care surgery will occur before adjuvant therapy.
* It is recommended that radiation therapy begin within 28 to 49 days (and no later than 56 days).
* The total dose to the postoperative tumor bed will be 3000 cGy in 15 fractions of 200 cGy over 3 weeks.
* Additional regions in the ipsilateral and contralateral neck at risk for microscopic disease in the cervical lymph nodes will receive 2700 cGy in 15 fractions of 180 cGy each.
* Cisplatin will be given on the same day as one of the initial 5 doses of radiation therapy. Receives: Radiation: Radiation therapy; Drug: Cisplatin; Procedure: Surgery |
What is being measured
The primary outcome is the main question the study is designed to answer.
Recurrence rate
Measured: At 2 years
Secondary outcomes (8)
Percent weight loss
For assessing percent weight loss, weight (kg) will be collected weekly during radiation within each arm, starting at Day 1 of RT and ending on the last day of RT. The percent weight loss from the baseline is calculated at any post-baseline.
Measured: From start of radiation therapy to completion of radiation therapy (estimated to be 6 weeks)
Proportion of patients undergoing PEG tube placement
Measured: Through completion of follow-up (estimated to be 5 years and 10 weeks)
Duration of need for an indwelling PEG tube
Measured: Through completion of follow-up (estimated to be 5 years and 10 weeks)
Proportion of patients taking narcotic
Measured: Through completion of follow-up (estimated to be 5 years and 10 weeks)
Number of participants with adverse events
Measured: From start of surgery through 24-month follow-up visit (estimated to be 2 years and 10 weeks)
Mean change in serum creatinine during radiation therapy
Serum creatinine levels are collected at Day 1 of RT and ending on the last day of RT.
Measured: From start of radiation therapy to completion of radiation therapy (estimated to be 6 weeks)
Progression-free survival (PFS)
PFS will be calculated from the date of surgery to the date of progression, death of any cause, or last known date alive.
Measured: Through completion of follow-up (estimated to be 5 years and 10 weeks)
Overall survival (OS)
OS will be calculated from the date of surgery to the date of death or last known date alive.
Measured: Through completion of follow-up (estimated to be 5 years and 10 weeks)
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted22 Nov 2024
- Study start10 Apr 2025
- Primary completion30 Apr 2030 (estimated)
- Study completion15 Jul 2033 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for HPV-Related Oropharynx Squamous Cell CarcinomaStudies of the same condition, open and under way.
- More trials run by Washington University School of MedicineThe 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
- Model description
- * Highest risk pathology (pT4) = remove from trial. * High-risk pathology = Arm 1 * Intermediate-risk pathology will be randomized to Arm 2A, Arm 2B, or Arm 2C. * Low-risk pathology = remove from trial.
- Masking
- None (open label)
- Enrolment
- 142 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Washington University School of Medicine
- Sponsor type
- University, hospital or other
- Collaborators
- The Joseph Sanchez Foundation
- Responsible party
- Sponsor
- Investigators
- Douglas Adkins, M.D., Principal investigator, Washington University School of Medicine
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06702033
- Sponsor's protocol ID
- 202501127
- Acronym
- MINT-2
- Status last verified
- Jul 2026
- First submitted
- 19 Nov 2024
- Last updated
- 24 Jul 2026
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- Yes
- FDA-regulated device
- No
- Individual data sharing
- Yes: Individual participant data that underlie the results reported in this article, after de-identification (text, tables, figures, and appendices), and the study protocol will be shared, beginning 9 months and ending 24 months following article publication, with investigators whose proposed use of the data has been approved by an independent review committee ("learned intermediary") identified for this purpose. Types of acceptable analyses include approved proposal(s) or individual participant data for meta-analyses.
Study at a glance
From the registry record, last updated by the sponsor on 24 Jul 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Phase II Trial of Surgery Followed by Risk-Directed Post-Operative Adjuvant Therapy for HPV-Related Oropharynx Squamous Cell Carcinoma: "The Minimalist Trial-2 (MINT-2)"
- ClinicalTrials.gov ID
- NCT06702033
- Acronym / sponsor ID
- MINT-2 / 202501127
- Keywords
- De-escalation, Adjuvant therapy, Oropharyngeal cancer, Human papillomavirus
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 142 participants (estimated)
- Lead sponsor
- Washington University School of MedicineUniversity, hospital or other
- Collaborators
- The Joseph Sanchez Foundation
- Study start
- 10 Apr 2025 (actual)
- Primary completion
- 30 Apr 2030 (estimated)
- Study completion
- 15 Jul 2033 (estimated)
- First posted
- 22 Nov 2024 (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.
Head and neck squamous cell carcinoma (HNSCC) is the sixth most common cancer. Oropharynx SCC (OPSCC) is a common sub-type of HNSCC. Each year, 16,000 new cases of OPSCC are diagnosed in the USA. Most cases of OPSCC (>90%) are caused by the human papillomavirus (HPV) and are often cured with current therapy.
However, patients treated with surgery followed by postoperative adjuvant chemotherapy and radiation therapy (POA(C)RT) still experience substantial morbidity. In this highly curable disease, current clinical research interest is focused on investigation of de-escalated therapy, with the goal to reduce treatment-related adverse events (AEs) while maintaining a low recurrence rate.
In this study, patients with HPV-related OPSCC will undergo resection of the primary tumor site and involved/at-risk regional neck nodes. Based on the pathology report, patients will be assigned to:
- Arm 1 (de-POACRT-42 Gy)
- Arm 2A (de-POART-42 Gy)
- Arm 2B (de-POART-37.8 Gy)
- Arm 2C (de-POACRT-30 Gy).
All patients with high-risk pathology will be assigned to Arm 1 whereas patients with intermediate-risk pathology will be randomized (1:1:1) to Arm 2A, Arm 2B, or Arm 2C. Patients with highest-risk pathology and low-risk pathology will be removed from the trial after surgery and will be advised to pursue standard of care options.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 4
- Model description
- * Highest risk pathology (pT4) = remove from trial. * High-risk pathology = Arm 1 * Intermediate-risk pathology will be randomized to Arm 2A, Arm 2B, or Arm 2C. * Low-risk pathology = remove from trial.
| Arm | Type | Receives |
|---|---|---|
| Arm 1: Radiation therapy + Cisplatin | Experimental | Radiation: Radiation therapy, Drug: Cisplatin, Procedure: Surgery* Standard of care surgery will occur before adjuvant therapy. * It is recommended that radiation therapy begin within 28 to 49 days (and no later than 56 days). * The total dose to the postoperative tumor bed will be 4200 cGy in 21 fractions of 200 cGy each over 4 weeks. * Additional regions in the ipsilateral and contralateral neck at risk for microscopic disease in the cervical lymph nodes will receive 3780 cGy in 21 fractions of 180 cGy each. * Cisplatin will be given on the same day as one of the initial 5 doses of radiation therapy. |
| Arm 2A: Radiation therapy | Experimental | Radiation: Radiation therapy, Procedure: Surgery* Standard of care surgery will occur before adjuvant therapy. * It is recommended that radiation therapy begin within 28 to 49 days (and no later than 56 days). * The total dose to the postoperative tumor bed will be 4200 cGy in 21 fractions of 200 cGy each over 4 weeks. * Additional regions in the ipsilateral and contralateral neck at risk for microscopic disease in the cervical lymph nodes will receive 3780 cGy in 21 fractions of 180 cGy each. |
| Arm 2B: Radiation therapy | Experimental | Radiation: Radiation therapy, Procedure: Surgery* Standard of care surgery will occur before adjuvant therapy. * It is recommended that radiation therapy begin within 28 to 49 days (and no later than 56 days). * The total dose to the postoperative tumor bed will be 3780 cGY in 21 fractions of 180 cGy each over 4 weeks. * Additional regions in the ipsilateral and contralateral neck at risk for microscopic disease in the cervical lymph nodes will receive 3360 cGy in 21 fractions of 160 cGy each. |
| Arm 2C: Radiation therapy + Cisplatin | Experimental | Radiation: Radiation therapy, Drug: Cisplatin, Procedure: Surgery* Standard of care surgery will occur before adjuvant therapy. * It is recommended that radiation therapy begin within 28 to 49 days (and no later than 56 days). * The total dose to the postoperative tumor bed will be 3000 cGy in 15 fractions of 200 cGy over 3 weeks. * Additional regions in the ipsilateral and contralateral neck at risk for microscopic disease in the cervical lymph nodes will receive 2700 cGy in 15 fractions of 180 cGy each. * Cisplatin will be given on the same day as one of the initial 5 doses of radiation therapy. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (11 listed)
- Histologically or cytologically confirmed HPV-related, clinical stages I-II OPSCC (8th edition of AJCC/UICC Staging Manual) or HPV-related neck node with unknown primary. Clinical T1N0M0 and T2N0M0 disease are excluded. HPV-related may be defined by p16 IHC stain and/or HPV-High Risk RNA ISH/HPV DNA genotyping by PCR, using standard definitions of positive and negative test results.
- Planned resection of the primary tumor site by a transoral approach (TORS, TLM, or conventional surgery).
- Planned unilateral or contralateral selective neck dissection.
- ECOG PS 0-2.
- Adequate organ and marrow function defined as:
Key exclusion criteria (8 listed)
- Clinical T1N0M0 or T2N0M0 disease.
- Prior radiation therapy for HNSCC.
- Planned free-flap reconstruction of the resected primary site.
- Cirrhosis with Child-Pugh Score B or C.
- History of prior invasive malignancy diagnosed within 2 years prior to study enrollment; exceptions are malignancies with a low risk of metastasis or death (e.g., expected 5-year OS > 90%) that were treated with curative-intent therapy.
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 |
|---|---|---|
| Radiation therapyIMRT or IMPT | Radiation | Arm 1: Radiation therapy + Cisplatin, Arm 2A: Radiation therapy, Arm 2B: Radiation therapy, Arm 2C: Radiation therapy + Cisplatin |
| CisplatinDose of 100 mg/m^2 IVPB over 60 minutes | Drug | Arm 1: Radiation therapy + Cisplatin, Arm 2C: Radiation therapy + Cisplatin |
| SurgeryStandard of care | Procedure or surgery | Arm 1: Radiation therapy + Cisplatin, Arm 2A: Radiation therapy, Arm 2B: Radiation therapy, Arm 2C: Radiation therapy + Cisplatin |
Primary outcome
Recurrence rate
Time frame: At 2 years
8 secondary outcomes
Percent weight loss
Time frame: From start of radiation therapy to completion of radiation therapy (estimated to be 6 weeks)
Proportion of patients undergoing PEG tube placement
Time frame: Through completion of follow-up (estimated to be 5 years and 10 weeks)
Duration of need for an indwelling PEG tube
Time frame: Through completion of follow-up (estimated to be 5 years and 10 weeks)
Proportion of patients taking narcotic
Time frame: Through completion of follow-up (estimated to be 5 years and 10 weeks)
Number of participants with adverse events
Time frame: From start of surgery through 24-month follow-up visit (estimated to be 2 years and 10 weeks)
Mean change in serum creatinine during radiation therapy
Time frame: From start of radiation therapy to completion of radiation therapy (estimated to be 6 weeks)
Progression-free survival (PFS)
Time frame: Through completion of follow-up (estimated to be 5 years and 10 weeks)
Overall survival (OS)
Time frame: Through completion of follow-up (estimated to be 5 years and 10 weeks)
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 24 Jul 2026.
- Alvin J. Siteman Cancer Center at Barnes-Jewish Hospital and Washington University School of MedicineLink provided by the sponsor.
- Individual participant dataSharing planned: Yes. Individual participant data that underlie the results reported in this article, after de-identification (text, tables, figures, and appendices), and the study protocol will be shared, beginning 9 months and ending 24 months following article publication, with investigators whose proposed use of the data has been approved by an independent review committee ("learned intermediary") identified for this purpose. Types of acceptable analyses include approved proposal(s) or individual participant data for meta-analyses.
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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.
Douglas Adkins, M.D. principal investigator
Washington University School of Medicine
3 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 2 study testing Radiation therapy, Cisplatin and Surgery in people with HPV-Related Oropharynx Squamous Cell Carcinoma, run by Washington University School of Medicine at 3 sites 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 11 inclusion and 8 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 24 Jul 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 3 sites 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 Douglas Adkins, M.D. (314-747-8475, dadkins@wustl.edu), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Recurrence rate (time frame: 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 24 Jul 2026.