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

NCT06309225 | Recruiting

• 1 other identifier: BMDA-2301
• Study Type: interventional
• Target: 20
• Locations: 1 country
• Sites: 1

Brief 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. 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.

Conditions

Oropharynx Cancer; Frailty

Outcome Measures

Primary Outcomes (1)

• 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.

  2 years

Secondary Outcomes (4)

• Benefit and Tolerance of Treatment

  2 years

• Acute Toxicity

  2 years

• Late toxicity

  2 years

• Failure pattern

  2 years

Study Arms (1)

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

Radiation: Modified dose and fields intensity modulated radiotherapy

Interventions

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.

Experimental

Eligibility Criteria

• Age: 65 Years - 99 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• Omar Mahmoud: lead

Study Sites (1)

Baptist MD Anderson Cancer Center

Jacksonville, Florida, 32207, United States

RECRUITING

MeSH Terms

Conditions

Oropharyngeal Neoplasms; Frailty

Condition Hierarchy (Ancestors)

Pharyngeal Neoplasms; Otorhinolaryngologic Neoplasms; Head and Neck Neoplasms; Neoplasms by Site; Neoplasms; Pharyngeal Diseases; Stomatognathic Diseases; Otorhinolaryngologic Diseases; Pathologic Processes; Pathological Conditions, Signs and Symptoms

Central Study Contacts

Regulatory Office

CONTACT

904-202-7300; RegBMDA@bmcjax.com

Clinical Trials Office

CONTACT

clinicaltrialsdivision@bmcjax.com

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: SPONSOR INVESTIGATOR
• PI Title: Principal Investigator

Study Record Dates

• First Submitted: February 22, 2024
• First Posted: March 13, 2024
• Study Start: May 15, 2025
• Primary Completion (Estimated): September 30, 2026
• Study Completion (Estimated): September 30, 2026
• Last Updated: May 22, 2025

Record last verified: 2025-05

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)