Oropharynx Cancer(DACHOC-E)NCT06309225
Dose Adjusted Chemoradiotherapy in HPV-Associated Oropharynx Cancer of the Elderly
A study testing Modified dose and fields intensity modulated radiotherapy in people with Oropharynx Cancer and Frailty, run by Omar Mahmoud at 1 site in United States.
Trial summary
Previous studies of this type of head and necl cancer have shown high rates of cancer control but result in many short and long term side effects when treated with high dose radiation and chemotherapy. Read more about this study
- Who is it for?
- Ages 65 to 99 years
- Conditions the study is for
- Oropharynx Cancer, Frailty
- What is being tested?
- Modified dose and fields intensity modulated radiotherapy
- Type of treatment
- Injection or infusion, Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 20 participants
- Where
- 1 siteUnited States
- Study dates
- 15 Dec 2025to 30 Sep 2027
- Phase
- Interventional
- 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 65 to 99 years
- All sexes
- No healthy volunteers
- Older adult
Who may be able to join
- Pathologically proven diagnosis of squamous cell carcinoma of the oropharynx (tonsil, base of tongue, soft palate, or oropharyngeal walls)
- Patients must have clinically or radiographically evident measurable disease at the primary site or at nodal stations.
- P16-positive based on local site immunohistochemical tissue staining
- Clinical stage T1-3, N1-2, M0 (AJCC, 8th ed.)
- Age ≥ 65.
- Normal organ and marrow function within 14 days prior to registration defined as follows:
Show all 12Show fewer
- Absolute neutrophil count ≥ 1,500/mcL
- Platelets ≥ 100,000/mcL
- Hemoglobin ≥ 8.0 g/dL
- Total bilirubin ≤ 1.5× institutional upper limit of normal (ULN)
- AST(SGOT) or ALT(SGPT) ≤ 3.0 × institutional ULN
- Serum creatinine ≤ 1.5× ULN
Who cannot join
- Metastatic disease
- Recurrent disease after primary management Cancers with center of mass is outside the oropharyngeal boundaries
- Synchronous double primaries
- Prior radiotherapy for lymphoma or other malignancy
- Prior systemic therapy including immunotherapy
- Severe active comorbidity where life expectancy is <1 year.
- Autoimmune disease
- Uncontrolled HIV
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
Clinical Trials Office contact
United States1 site, 1 recruiting
- Recruiting
Baptist MD Anderson Cancer Center
Jacksonville, Florida, 32207
Clinical Trials and Translational Medicine Divsion, clinicaltrialsdivision@bmcjax.com
About this study
Official title: Pilot Feasibility Trial of Dose Adjusted Chemoradiotherapy in HPV-Associated Oropharynx Cancer of the Elderly (DACHOC-E)
Previous studies of this type of head and necl cancer have shown high rates of cancer control but result in many short and long term side effects when treated with high dose radiation and chemotherapy. Recently, investigators have noticed similar high rates of cancer control in small numbers of patients who receive less intensive treatments using lower doses of radiation, smaller radiation fields with chemotherapy. It is expected that the side effects of treatment with lower doses of radiation would be less.
For this reason this study is looking at a different regimen of reducing the intensity of the treatment.
The purpose of this study is to compare any good and bad effects of using lower dose smaller fields radiation therapy and chemotherapy with published outcomes. This study will allow the researchers to know whether these different approaches are better, the same, or worse than the usual approach. To be better, the study approach should result in the same survival rate of the usual approach (about 85 out of 100 patients alive and free of cancer at 2 years) but with less long-term side effects.
Read the detailed description
There will be about 30 people taking part in this study. This study has one study group. All the people on the study will receive radiation therapy once a day, 5 days a week (for a total of 55 Gy over 5 weeks) and chemotherapy, cisplatin, (given through the vein for about 30-60 minutes) once a week for 5 weeks.
Medications and saline solutions to prevent side effects of chemotherapy may also be given by vein and may prolong your time in the chemotherapy clinic to as much as 4-6 hours.
Standard regimen not delivered on this study pertains to radiation therapy and chemotherapy, cisplatin in a schedule of 5 treatments a week for a total of 69.96 Gy over 6.5 weeks.
- Conditions
- Oropharynx Cancer, Frailty
- Being tested
- Modified dose and fields intensity modulated radiotherapy
- Medical subject headings
- Oropharyngeal Neoplasms, Frailty
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Modified dose and fields intensity modulated radiotherapyRadiation
Instead of standard bilateral or extensive neck fields, the current radiation fields will cover disease with only 3cm expansion. The clinical target volumes doses are biologically equivalent to the standard but given in a shorter hypofractionated approach.
| Study group | Role | What they receive |
|---|---|---|
| Experimental | Experimental | Cisplatin: 30-40 mg/m2/week, every week during radiation. Dose should be based on actual body weight. The first cisplatin infusion should be started within 24 hours before or after the first scheduled radiation treatment.
Intensity Modulated Radiation Therapy (IMRT) and Image-Guided Radiation Therapy (IGRT) are mandatory for this study.
55 Gy radiation in 5 weeks using 5 fractions per week + Cisplatin every week Receives: Radiation: Modified dose and fields intensity modulated radiotherapy |
What is being measured
The primary outcome is the main question the study is designed to answer.
Two-year progression free survival
Assuming the primary endpoint (non-inferior 2 year locoregional control) is met and both of these toxicity outcome goals are met, then concurrent short course radiotherapy would be considered an effective and less toxic alternative to concurrent standard arm, in locally advanced HPV-associated carcinoma of the oropharynx.
Measured: 2 years
Secondary outcomes (4)
Benefit and Tolerance of Treatment
Frailty index G8 score 14 as major determinant of benefit and tolerance to treatment through:
Per prior study score <14 (1-17) is an indicator of frailty. The frailty as a factor in completing therapy (yes or no) and number of days break from therapy will be used as a variable.
G20 frailty index (G-20 is the actual name and not abbreviation) is as follows:
A Has food intake declined over the past 3 months due to loss of appetite, digestive problems, chewing or swallowing difficulties? B Weight loss during the last 3 months C Mobility D Neuropsychological problems E Body Mass Index (BMI (weight in kg) / (height in m²) F Takes more than 3 medications per day G In comparison with other people of the same age, how does the patient consider his/her health status? H Age
Measured: 2 years
Acute Toxicity
Acute toxicity (Grade 3 or higher)
Measured: 2 years
Late toxicity
Late toxicity (Grade 3 or higher)
Measured: 2 years
Failure pattern
Pattern failure (local in field, local marginal miss, local regional failure, distant failure, combination of the above).
As some of the patient may have recurrence in the radiation fields, this will be termed local recurrence. Recurrence outside the radiation fields but in the head and neck area will be quantified as regional failure. Failure outside the head and neck area will be classified as distant failure. This outcome will be quantified as global number of failure out of the 20 patients and their distribution will be quantified in a diagram as explain above.
Measured: 2 years
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted13 Mar 2024
- Study start15 Dec 2025
- Primary completion30 Sep 2027 (estimated)
- Study completion30 Sep 2027 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Oropharynx CancerStudies 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
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 20 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Omar Mahmoud
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor-investigator, Omar Mahmoud, Baptist MD Anderson Cancer Center, Florida
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06309225
- Sponsor's protocol ID
- BMDA-2301
- Acronym
- (DACHOC-E)
- Status last verified
- Sep 2026
- First submitted
- 22 Feb 2024
- Last updated
- 29 Sep 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 29 Sep 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Pilot Feasibility Trial of Dose Adjusted Chemoradiotherapy in HPV-Associated Oropharynx Cancer of the Elderly (DACHOC-E)
- ClinicalTrials.gov ID
- NCT06309225
- Acronym / sponsor ID
- (DACHOC-E) / BMDA-2301
- Conditions
- Oropharynx Cancer, Frailty
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 20 participants (estimated)
- Lead sponsor
- Omar MahmoudUniversity, hospital or other
- Study start
- 15 Dec 2025 (actual)
- Primary completion
- 30 Sep 2027 (estimated)
- Study completion
- 30 Sep 2027 (estimated)
- First posted
- 13 Mar 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.
Previous studies of this type of head and necl cancer have shown high rates of cancer control but result in many short and long term side effects when treated with high dose radiation and chemotherapy. Recently, investigators have noticed similar high rates of cancer control in small numbers of patients who receive less intensive treatments using lower doses of radiation, smaller radiation fields with chemotherapy. It is expected that the side effects of treatment with lower doses of radiation would be less.
For this reason this study is looking at a different regimen of reducing the intensity of the treatment.
The purpose of this study is to compare any good and bad effects of using lower dose smaller fields radiation therapy and chemotherapy with published outcomes. This study will allow the researchers to know whether these different approaches are better, the same, or worse than the usual approach. To be better, the study approach should result in the same survival rate of the usual approach (about 85 out of 100 patients alive and free of cancer at 2 years) but with less long-term side effects.
Detailed description
There will be about 30 people taking part in this study. This study has one study group. All the people on the study will receive radiation therapy once a day, 5 days a week (for a total of 55 Gy over 5 weeks) and chemotherapy, cisplatin, (given through the vein for about 30-60 minutes) once a week for 5 weeks.
Medications and saline solutions to prevent side effects of chemotherapy may also be given by vein and may prolong your time in the chemotherapy clinic to as much as 4-6 hours.
Standard regimen not delivered on this study pertains to radiation therapy and chemotherapy, cisplatin in a schedule of 5 treatments a week for a total of 69.96 Gy over 6.5 weeks.
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Experimental | Experimental | Radiation: Modified dose and fields intensity modulated radiotherapyCisplatin: 30-40 mg/m2/week, every week during radiation. Dose should be based on actual body weight. The first cisplatin infusion should be started within 24 hours before or after the first scheduled radiation treatment. Intensity Modulated Radiation Therapy (IMRT) and Image-Guided Radiation Therapy (IGRT) are mandatory for this study. 55 Gy radiation in 5 weeks using 5 fractions per week + Cisplatin every week |
Who may qualify
- Ages
- 65 to 99 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Older adult
Key inclusion criteria (12 listed)
- Pathologically proven diagnosis of squamous cell carcinoma of the oropharynx (tonsil, base of tongue, soft palate, or oropharyngeal walls)
- Patients must have clinically or radiographically evident measurable disease at the primary site or at nodal stations.
- P16-positive based on local site immunohistochemical tissue staining
- Clinical stage T1-3, N1-2, M0 (AJCC, 8th ed.)
- Age ≥ 65.
Key exclusion criteria (8 listed)
- Metastatic disease
- Recurrent disease after primary management Cancers with center of mass is outside the oropharyngeal boundaries
- Synchronous double primaries
- Prior radiotherapy for lymphoma or other malignancy
- Prior systemic therapy including immunotherapy
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 |
|---|---|---|
| Modified dose and fields intensity modulated radiotherapyInstead of standard bilateral or extensive neck fields, the current radiation fields will cover disease with only 3cm expansion. The clinical target volumes doses are biologically equivalent to the standard but given in a shorter hypofractionated approach. | Radiation | Experimental |
Primary outcome
Two-year progression free survival
Time frame: 2 years
Assuming the primary endpoint (non-inferior 2 year locoregional control) is met and both of these toxicity outcome goals are met, then concurrent short course radiotherapy would be considered an effective and less toxic alternative to concurrent standard arm, in locally advanced HPV-associated carcinoma of the oropharynx.
4 secondary outcomes
Benefit and Tolerance of Treatment
Time frame: 2 years
Acute Toxicity
Time frame: 2 years
Late toxicity
Time frame: 2 years
Failure pattern
Time frame: 2 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 29 Sep 2026.
- 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.
Clinical Trials Office contact
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Modified dose and fields intensity modulated radiotherapy in people with Oropharynx Cancer and Frailty, run by Omar Mahmoud 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 12 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 29 Sep 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.
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 Regulatory Office (904-202-7300, RegBMDA@bmcjax.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Two-year progression free survival (time frame: 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 29 Sep 2026.