HPV Related Oropharyngeal Squamous Cell CarcinomaPhase 2MINTNCT03621696
Surgery Followed by Risk-Directed Post-Operative Adjuvant Therapy for HPV-Related Oropharynx Squamous Cell Carcinoma: "The Minimalist Trial (MINT)"
A Phase 2 study testing Cisplatin, Intensity modulated radiation therapy and Intensity modulated proton therapy in people with HPV Related Oropharyngeal Squamous Cell Carcinoma, run by Washington University School of Medicine at 1 site in United States.
Trial summary
The overarching goal of the MINT trial is to reduce treatment-related toxicity while maintaining efficacy. Patients with HPV-related oropharyngeal squamous cell carcinoma (OPSCC) will undergo resection of the primary tumor site and involved/at risk regional neck nodes. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- HPV Related Oropharyngeal Squamous Cell Carcinoma
- What is being tested?
- Cisplatin, Intensity modulated radiation therapy and Intensity modulated proton therapy
- Type of treatment
- Injection or infusion, Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 63 participants
- Where
- 1 siteUnited States
- Study dates
- 23 Oct 2018to 17 Mar 2026
- Phase
- Phase 2
- Are there results?
- Yes, posted in the registrySummary in the doctors' view
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 stages I-III OPSCC (8th edition of AJCC/UICC Staging Manual) or HPV-related neck node with unknown primary. HPV-related may be defined by p16 IHC stain and/or HPV-ISH or PCR using standard definitions of positive and negative test results.
- Primary tumor that will be resected via a transoral oral approach (conventional surgery, transoral laser microsurgery, transoral robotic surgery)
- Eastern Cooperative Oncology Group (ECOG) Performance Status (PS) 0-2.
- Normal organ and marrow function defined as:
- Creatinine clearance > 50 cc/min.
- ANC > 1,000/mcL.
Show all 10Show fewer
- Platelet count >100,000/mcL.
- 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.
- Patient (or legally authorized representative) must be able to understand and willing to sign a written informed consent document.
Who cannot join
- Prior curative therapy for HNSCC.
- Patient must not have known distant metastatic disease at presentation.
- 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 overall survival (OS) > 90%) that were treated with an expected curative outcome, such as squamous cell carcinoma of the skin, in-situ carcinoma of the cervix uteri, non-melanomatous skin cancer, carcinoma in situ of the breast, or incidental histological finding of prostate cancer (TNM stage of T1a or T1b).
- 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 or urine pregnancy test is required at screening for all female patients of childbearing potential.
Trial locations and contacts
1 site in 1 country.
United States1 site
Washington University School of Medicine
St Louis, Missouri, 63110
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 (MINT)"
The overarching goal of the MINT trial is to reduce treatment-related toxicity while maintaining efficacy. Patients with HPV-related oropharyngeal squamous cell carcinoma (OPSCC) will undergo resection of the primary tumor site and involved/at risk regional neck nodes.
- Being tested
- Cisplatin, Intensity modulated radiation therapy, Intensity modulated proton therapy, Surgery, FACT-H&N
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
CisplatinDrug
Also called Platinol®, Platinol-AQ®
-100 mg/m^2 intravenous push bolus (IVPB)
Intensity modulated radiation therapyRadiation
Also called IMRT
-IMRT or IMPT can be used
Intensity modulated proton therapyRadiation
Also called IMPT
-IMRT or IMPT can be used
SurgeryProcedure or surgery
-Standard of care
FACT-H&NOther
-Baseline, interim assessment (14-42 days post-surgery), day 1 of radiation, day 21 of radiation, day 36 of radiation, 6 weeks after completion of adjuvant therapy, 4 months after the completion of adjuvant therapy, 6 months after the completion of adjuvant therapy, 12 months after the completion of adjuvant therapy, and 24 months after completion of adjuvant therapy
MD Anderson Dysphagia InventoryOther
-Baseline, interim assessment (14-42 days post-surgery), day 1 of radiation, day 21 of radiation, day 36 of radiation, 6 weeks after completion of adjuvant therapy, 4 months after the completion of adjuvant therapy, 6 months after the completion of adjuvant therapy, 12 months after the completion of adjuvant therapy, and 24 months after completion of adjuvant therapy
University of Michigan Xerostomia IndexOther
-Baseline, interim assessment (14-42 days post-surgery), day 1 of radiation, day 21 of radiation, day 36 of radiation, 6 weeks after completion of adjuvant therapy, 4 months after the completion of adjuvant therapy, 6 months after the completion of adjuvant therapy, 12 months after the completion of adjuvant therapy, and 24 months after completion of adjuvant therapy
Scale of Subjective Total Taste AcuityOther
-Baseline, interim assessment (14-42 days post-surgery), day 1 of radiation, day 21 of radiation, day 36 of radiation, 6 weeks after completion of adjuvant therapy, 4 months after the completion of adjuvant therapy, 6 months after the completion of adjuvant therapy, 12 months after the completion of adjuvant therapy, and 24 months after completion of adjuvant therapy
Neck Dissection Impairment IndexOther
-Baseline, interim assessment (14-42 days post-surgery), day 1 of radiation, day 21 of radiation, day 36 of radiation, 6 weeks after completion of adjuvant therapy, 4 months after the completion of adjuvant therapy, 6 months after the completion of adjuvant therapy, 12 months after the completion of adjuvant therapy, and 24 months after completion of adjuvant therapy
| Study group | Role | What they receive |
|---|---|---|
| Arm 1: POAmCRT | Experimental | * Patients with extracapsular extension (ECE) or positive margin but not clinical or pathologic T4 or clinical N3 disease
* Standard of care surgery (surgical resection of the primary tumor via a transoral approach and surgical management of cervical lymph nodes
* Treated with post-operative adjuvant modified chemoradiation therapy (POAmCRT) which is 42 Gy radiation therapy in 21 doses and 1 dose of cisplatin.
* It is recommended that radiation therapy begin within 28-49 days (no later than 56 days) after surgical resection
* Intensity modulated radiation therapy (IMRT) or intensity modulated proton therapy (IMPT) is to be used for this study Receives: Drug: Cisplatin; Radiation: Intensity modulated radiation therapy; Radiation: Intensity modulated proton therapy; Procedure: Surgery; Other: FACT-H&N; Other: MD Anderson Dysphagia Inventory; Other: University of Michigan Xerostomia Index; Other: Scale of Subjective Total Taste Acuity; Other: Neck Dissection Impairment Index |
| Arm 2: POAmRT | Experimental | * Patients with no extracapsular extension (ECE) and no positive margins and not clinical or pathologic T4 or clinical N3 disease
* Standard of care surgery (surgical resection of the primary tumor via a transoral approach and surgical management of cervical lymph nodes
* Treated with post-operative adjuvant modified radiation therapy (POAmRT) which is 42 Gy radiation therapy in 21 doses
* It is recommended that radiation therapy begin within 28-49 days (no later than 56 days) after surgical resection
* Intensity modulated radiation therapy (IMRT) or intensity modulated proton therapy (IMPT) is to be used for this study Receives: Radiation: Intensity modulated radiation therapy; Radiation: Intensity modulated proton therapy; Procedure: Surgery; Other: FACT-H&N; Other: MD Anderson Dysphagia Inventory; Other: University of Michigan Xerostomia Index; Other: Scale of Subjective Total Taste Acuity; Other: Neck Dissection Impairment Index |
| Arm 3: POACRT | Experimental | * Patients with clinical or pathologic T4 or clinical N3 disease
* Standard of care surgery (surgical resection of the primary tumor via a transoral approach and surgical management of cervical lymph nodes
* Treated with post-operative adjuvant chemoradiation therapy (POACRT) which is 60 Gy radiation therapy in 30 doses and 3 doses of cisplatin (if there is pathologic evidence of ECE or positive margins)
* The first dose of cisplatin will given on one of the days during the initial 5 days of radiation therapy, the 2nd dose on the day of radiation dose 16, and the 3rd dose on the day of radiation dose 26.
* It is recommended that radiation therapy begin within 28-49 days (no later than 56 days) after surgical resection
* Intensity modulated radiation therapy (IMRT) or intensity modulated proton therapy (IMPT) is to be used for this study Receives: Drug: Cisplatin; Radiation: Intensity modulated radiation therapy; Radiation: Intensity modulated proton therapy; Procedure: Surgery; Other: FACT-H&N; Other: MD Anderson Dysphagia Inventory; Other: University of Michigan Xerostomia Index; Other: Scale of Subjective Total Taste Acuity; Other: Neck Dissection Impairment Index |
What is being measured
The primary outcome is the main question the study is designed to answer.
Mean Percent Weight Change
- Weight in kilograms will be collected weekly during radiation
- The percent weight loss from the baseline is calculated at any post-baseline
Measured: Starting at Day 1 and ending on the last day of radiation therapy (approximately 4 weeks)
Secondary outcomes (6)
Proportion of PEG Tube Placements in Each Arm
-95% confidence intervals will be calculated assuming a binomial distribution
Measured: Through completion of follow-up (approximately 63 months)
Change in Serum Creatinine
Measured: Baseline to 6 weeks after POAmCRT (approximately 90 days)
Percentage of Participants Taking Narcotics
-95% confidence intervals will be calculated assuming a binomial distribution
Measured: 6 weeks after POAmCRT (approximately 90 days)
Disease Recurrence Rate
Measured: 24 months post-treatment (approximately 27 months)
Progression-free Survival (PFS)
Measured: Through completion of follow-up (approximately 63 months)
Overall Survival (OS)
Measured: Through completion of follow-up (approximately 63 months)
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted8 Aug 2018
- Study start23 Oct 2018
- Primary completion10 Mar 2021
- Study completion17 Mar 2026
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
- Other trials for HPV Related Oropharyngeal 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
- Non-randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 63 participants (actual)
Sponsor and investigators
- Lead sponsor
- Washington University School of Medicine
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Douglas Adkins, M.D., Principal investigator, Washington University School of Medicine
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03621696
- Sponsor's protocol ID
- 201808045
- Acronym
- MINT
- Status last verified
- Mar 2026
- First submitted
- 26 Jul 2018
- Last updated
- 21 Apr 2026
- Results posted
- Yes, on ClinicalTrials.gov
- 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 21 Apr 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 (MINT)"
- ClinicalTrials.gov ID
- NCT03621696
- Acronym / sponsor ID
- MINT / 201808045
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 63 participants (actual)
- Lead sponsor
- Washington University School of MedicineUniversity, hospital or other
- Study start
- 23 Oct 2018 (actual)
- Primary completion
- 10 Mar 2021 (actual)
- Study completion
- 17 Mar 2026 (actual)
- First posted
- 8 Aug 2018 (actual)
- Results
- Posted 11 Mar 2022
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
The overarching goal of the MINT trial is to reduce treatment-related toxicity while maintaining efficacy. Patients with HPV-related oropharyngeal squamous cell carcinoma (OPSCC) will undergo resection of the primary tumor site and involved/at risk regional neck nodes.
Study design
- Primary purpose
- Treatment
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| Arm 1: POAmCRT | Experimental | Drug: Cisplatin, Radiation: Intensity modulated radiation therapy, Radiation: Intensity modulated proton therapy, Procedure: Surgery, Other: FACT-H&N, Other: MD Anderson Dysphagia Inventory, Other: University of Michigan Xerostomia Index, Other: Scale of Subjective Total Taste Acuity, Other: Neck Dissection Impairment Index* Patients with extracapsular extension (ECE) or positive margin but not clinical or pathologic T4 or clinical N3 disease * Standard of care surgery (surgical resection of the primary tumor via a transoral approach and surgical management of cervical lymph nodes * Treated with post-operative adjuvant modified chemoradiation therapy (POAmCRT) which is 42 Gy radiation therapy in 21 doses and 1 dose of cisplatin. * It is recommended that radiation therapy begin within 28-49 days (no later than 56 days) after surgical resection * Intensity modulated radiation therapy (IMRT) or intensity modulated proton therapy (IMPT) is to be used for this study |
| Arm 2: POAmRT | Experimental | Radiation: Intensity modulated radiation therapy, Radiation: Intensity modulated proton therapy, Procedure: Surgery, Other: FACT-H&N, Other: MD Anderson Dysphagia Inventory, Other: University of Michigan Xerostomia Index, Other: Scale of Subjective Total Taste Acuity, Other: Neck Dissection Impairment Index* Patients with no extracapsular extension (ECE) and no positive margins and not clinical or pathologic T4 or clinical N3 disease * Standard of care surgery (surgical resection of the primary tumor via a transoral approach and surgical management of cervical lymph nodes * Treated with post-operative adjuvant modified radiation therapy (POAmRT) which is 42 Gy radiation therapy in 21 doses * It is recommended that radiation therapy begin within 28-49 days (no later than 56 days) after surgical resection * Intensity modulated radiation therapy (IMRT) or intensity modulated proton therapy (IMPT) is to be used for this study |
| Arm 3: POACRT | Experimental | Drug: Cisplatin, Radiation: Intensity modulated radiation therapy, Radiation: Intensity modulated proton therapy, Procedure: Surgery, Other: FACT-H&N, Other: MD Anderson Dysphagia Inventory, Other: University of Michigan Xerostomia Index, Other: Scale of Subjective Total Taste Acuity, Other: Neck Dissection Impairment Index* Patients with clinical or pathologic T4 or clinical N3 disease * Standard of care surgery (surgical resection of the primary tumor via a transoral approach and surgical management of cervical lymph nodes * Treated with post-operative adjuvant chemoradiation therapy (POACRT) which is 60 Gy radiation therapy in 30 doses and 3 doses of cisplatin (if there is pathologic evidence of ECE or positive margins) * The first dose of cisplatin will given on one of the days during the initial 5 days of radiation therapy, the 2nd dose on the day of radiation dose 16, and the 3rd dose on the day of radiation dose 26. * It is recommended that radiation therapy begin within 28-49 days (no later than 56 days) after surgical resection * Intensity modulated radiation therapy (IMRT) or intensity modulated proton therapy (IMPT) is to be used for this study |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (10 listed)
- Histologically or cytologically confirmed HPV-related stages I-III OPSCC (8th edition of AJCC/UICC Staging Manual) or HPV-related neck node with unknown primary. HPV-related may be defined by p16 IHC stain and/or HPV-ISH or PCR using standard definitions of positive and negative test results.
- Primary tumor that will be resected via a transoral oral approach (conventional surgery, transoral laser microsurgery, transoral robotic surgery)
- Eastern Cooperative Oncology Group (ECOG) Performance Status (PS) 0-2.
- Normal organ and marrow function defined as:
- At least 18 years of age.
Key exclusion criteria (6 listed)
- Prior curative therapy for HNSCC.
- Patient must not have known distant metastatic disease at presentation.
- 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 overall survival (OS) > 90%) that were treated with an expected curative outcome, such as squamous cell carcinoma of the skin, in-situ carcinoma of the cervix uteri, non-melanomatous skin cancer, carcinoma in situ of the breast, or incidental histological finding of prostate cancer (TNM stage of T1a or T1b).
- Receiving any other investigational agents.
- Uncontrolled serious inter-current illness or serious psychiatric illness/social situations that would limit compliance with study requirements.
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 |
|---|---|---|
| CisplatinAlso: Platinol®, Platinol-AQ®-100 mg/m^2 intravenous push bolus (IVPB) | Drug | Arm 1: POAmCRT, Arm 3: POACRT |
| Intensity modulated radiation therapyAlso: IMRT-IMRT or IMPT can be used | Radiation | Arm 1: POAmCRT, Arm 2: POAmRT, Arm 3: POACRT |
| Intensity modulated proton therapyAlso: IMPT-IMRT or IMPT can be used | Radiation | Arm 1: POAmCRT, Arm 2: POAmRT, Arm 3: POACRT |
| Surgery-Standard of care | Procedure or surgery | Arm 1: POAmCRT, Arm 2: POAmRT, Arm 3: POACRT |
| FACT-H&N-Baseline, interim assessment (14-42 days post-surgery), day 1 of radiation, day 21 of radiation, day 36 of radiation, 6 weeks after completion of adjuvant therapy, 4 months after the completion of adjuvant therapy, 6 months after the completion of adjuvant therapy, 12 months after the completion of adjuvant therapy, and 24 months after completion of adjuvant therapy | Other | Arm 1: POAmCRT, Arm 2: POAmRT, Arm 3: POACRT |
| MD Anderson Dysphagia Inventory-Baseline, interim assessment (14-42 days post-surgery), day 1 of radiation, day 21 of radiation, day 36 of radiation, 6 weeks after completion of adjuvant therapy, 4 months after the completion of adjuvant therapy, 6 months after the completion of adjuvant therapy, 12 months after the completion of adjuvant therapy, and 24 months after completion of adjuvant therapy | Other | Arm 1: POAmCRT, Arm 2: POAmRT, Arm 3: POACRT |
| University of Michigan Xerostomia Index-Baseline, interim assessment (14-42 days post-surgery), day 1 of radiation, day 21 of radiation, day 36 of radiation, 6 weeks after completion of adjuvant therapy, 4 months after the completion of adjuvant therapy, 6 months after the completion of adjuvant therapy, 12 months after the completion of adjuvant therapy, and 24 months after completion of adjuvant therapy | Other | Arm 1: POAmCRT, Arm 2: POAmRT, Arm 3: POACRT |
| Scale of Subjective Total Taste Acuity-Baseline, interim assessment (14-42 days post-surgery), day 1 of radiation, day 21 of radiation, day 36 of radiation, 6 weeks after completion of adjuvant therapy, 4 months after the completion of adjuvant therapy, 6 months after the completion of adjuvant therapy, 12 months after the completion of adjuvant therapy, and 24 months after completion of adjuvant therapy | Other | Arm 1: POAmCRT, Arm 2: POAmRT, Arm 3: POACRT |
| Neck Dissection Impairment Index-Baseline, interim assessment (14-42 days post-surgery), day 1 of radiation, day 21 of radiation, day 36 of radiation, 6 weeks after completion of adjuvant therapy, 4 months after the completion of adjuvant therapy, 6 months after the completion of adjuvant therapy, 12 months after the completion of adjuvant therapy, and 24 months after completion of adjuvant therapy | Other | Arm 1: POAmCRT, Arm 2: POAmRT, Arm 3: POACRT |
Primary outcome
Mean Percent Weight Change
Time frame: Starting at Day 1 and ending on the last day of radiation therapy (approximately 4 weeks)
* Weight in kilograms will be collected weekly during radiation * The percent weight loss from the baseline is calculated at any post-baseline
6 secondary outcomes
Proportion of PEG Tube Placements in Each Arm
Time frame: Through completion of follow-up (approximately 63 months)
Change in Serum Creatinine
Time frame: Baseline to 6 weeks after POAmCRT (approximately 90 days)
Percentage of Participants Taking Narcotics
Time frame: 6 weeks after POAmCRT (approximately 90 days)
Disease Recurrence Rate
Time frame: 24 months post-treatment (approximately 27 months)
Progression-free Survival (PFS)
Time frame: Through completion of follow-up (approximately 63 months)
Overall Survival (OS)
Time frame: Through completion of follow-up (approximately 63 months)
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 21 Apr 2026.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
- Alvin J. Siteman Cancer Center at Barnes-Jewish Hospital and Washington University School of MedicineLink provided by the sponsor.
- Individual participant dataSharing planned: No
Related trials for HPV Related Oropharyngeal Squamous Cell Carcinoma
Active, not recruitingPhase 2
De-Escalation Radiotherapy in Patients With Low-Risk HPV-Related Oropharyngeal Squamous Cell Carcinoma
Oropharyngeal Cancer
RecruitingPhase 1/2
E7 T-cell Receptor (TCR) -T Cell Induction Therapy for Locoregionally Advanced HPV-associated Cancers
HPV-Associated Cervical Carcinoma, HPV-Related Carcinoma
RecruitingPhase 2
E7 TCR-T Cell Immunotherapy for Human Papillomavirus (HPV) Associated Cancers
Cervical Cancer, Throat Cancer
Active, not recruitingPhase 1/2
A Vaccine (PDS0101) Alone or in Combination With Pembrolizumab for the Treatment of Locally Advanced Human Papillomavirus-Associated Oropharynx Cancer
Clinical Stage III HPV-Mediated (p16-Positive) Oropharyngeal Carcinoma AJCC v8, Human Papillomavirus-Related Carcinoma
RecruitingPhase 2
De-Escalated Adjuvant and Definitive Radiation Therapy Informed by DART 2.0 ctHPV-DNA
Clinical Stage I HPV-Mediated (p16-Positive) Oropharyngeal Carcinoma AJCC v8, Clinical Stage II HPV-Mediated (p16-Positive) Oropharyngeal Carcinoma AJCC v8
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.
Douglas Adkins, M.D. principal investigator
Washington University School of Medicine
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, Intensity modulated radiation therapy and Intensity modulated proton therapy in people with HPV Related Oropharyngeal Squamous Cell Carcinoma, run by Washington University School of Medicine 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 10 inclusion and 6 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: finished, as of the sponsor's last update on 21 Apr 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
Yes. Results are posted in the registry (first posted 11 Mar 2022). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.
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?
Mean Percent Weight Change (time frame: Starting at Day 1 and ending on the last day of radiation therapy (approximately 4 weeks)). 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 21 Apr 2026.