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NCT Number: NCT06309225

Dose Adjusted Chemoradiotherapy in HPV-Associated Oropharynx Cancer of the Elderly

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.

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Key information

Conditions

Oropharynx Cancer Frailty Head and Neck Neoplasms Neoplasms Neoplasms by Site Oropharyngeal Neoplasms Otorhinolaryngologic Diseases Otorhinolaryngologic Neoplasms Pathologic Processes Pathological Conditions, Signs and Symptoms Pharyngeal Diseases Pharyngeal Neoplasms Stomatognathic Diseases

Age range

65 year–99 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Baptist MD Anderson Cancer Center

Jacksonville, Florida, 32207, United States

Location status: Recruiting

Location contact

Clinical Trials and Translational Medicine Divsion

CONTACT

[email protected]

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • 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:
  • 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

Exclusion criteria

  • 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

Treatment and study plan

Modified dose and fields intensity modulated radiotherapy

Radiation

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.

Primary outcomes

  1. 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.

Secondary outcomes

  1. Benefit and Tolerance of Treatment

    Time frame: 2 years

    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

  2. Acute Toxicity

    Time frame: 2 years

    Acute toxicity (Grade 3 or higher)

  3. Late toxicity

    Time frame: 2 years

    Late toxicity (Grade 3 or higher)

  4. Failure pattern

    Time frame: 2 years

    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.

Study contacts

Contact information is provided by the study sponsor or research team.

Clinical Trials Office

CONTACT

[email protected]

Regulatory Office

CONTACT

[email protected]

904-202-7300

Sponsors and collaborators

Lead sponsor

Omar Mahmoud

Other

Registry information

Official study title

Pilot Feasibility Trial of Dose Adjusted Chemoradiotherapy in HPV-Associated Oropharynx Cancer of the Elderly (DACHOC-E)

Acronym: (DACHOC-E)

Important dates

Study start
2025
Primary completion
2026
Study completion
2026
First posted
Mar 13, 2024
Registry last updated
May 22, 2025

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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