Recruiting

Lower Dose Therapy

Sponsor:

Omar Mahmoud

Code:

NCT06309225

Conditions

Oropharynx Cancer

Frailty

Eligibility Criteria

Sex: All

Age: 65 - 70+

Healthy Volunteers: Not accepted

Interventions

Modified dose and fields intensity modulated radiotherapy

Study Details

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

Study ID

NCT06309225

Start date

May 15, 2025

Status verified date

May, 2025

Completion date

Sep 30, 2026

Anticipated

Primary completion date

Sep 30, 2026

Anticipated

Eligibility Criteria

Eligibility Criteria

Sex: All

Age: 65 - 70+

Healthy Volunteers: Not accepted

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

Study Design

Enrollment

20 participants

Anticipated

Intervention Model

Single group

Primary purpose

Treatment

Interventions and Outcome Measures

Arms

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

Interventions

Modified dose and fields intensity modulated radiotherapy

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 outcome measure

  • Two-year progression free survival [ Time Frame: 2 years ]

Central Contacts and Locations

Central contacts

Regulatory Office

904-202-7300RegBMDA@bmcjax.com

Clinical Trials Office

clinicaltrialsdivision@bmcjax.com

Locations

Baptist MD Anderson Cancer Center

Recruiting

Jacksonville, Florida, United States, 32207

Contacts

Clinical Trials and Translational Medicine Divsion

clinicaltrialsdivision@bmcjax.com

More Information

Sponsor

Omar Mahmoud

Last update posted

May 22, 2025

Last verified

May, 2025

Trial information was received from ClinicalTrials.gov and was last updated on 2026-09-10. This information was provided to ClinicalTrials.gov by Omar Mahmoud on 2025-05-22.