Modified Radiotherapy for Oropharyngeal Cancer

((DACHOC-E) Trial)

Overseen By Clinical Trials Office

Age: 65+

Sex: Any

Trial Phase: Academic

Sponsor: Omar Mahmoud

Disqualifiers: Metastatic, Recurrent, Autoimmune, others

No Placebo Group All trial participants will receive the active study treatment (no placebo)

Compensation: Varies

Number of Visits: 5

Duration: 5 weeks

20 Participants Needed

Trial Summary

What is the purpose of this trial?

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.

Eligibility Criteria

This trial is for individuals aged 65 or older with HPV-associated squamous cell carcinoma of the oropharynx, who have measurable disease and are in specific clinical stages (T1-3, N1-2, M0). Participants must have adequate blood counts and liver function. Those with conditions that could interfere with the study or pose a risk to patient safety are excluded.

Inclusion Criteria

My white blood cell count is healthy.

My platelet count is at least 100,000 per microliter.

My hemoglobin level is at least 8.0 g/dL.

Timeline

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

Treatment

Participants receive radiation therapy once a day, 5 days a week for 5 weeks, and chemotherapy (cisplatin) once a week for 5 weeks

5 weeks

5 visits per week (in-person)

Follow-up

Participants are monitored for safety and effectiveness after treatment, with a focus on progression-free survival and toxicity outcomes

2 years

Treatment Details

Interventions

• Modified dose and fields intensity modulated radiotherapy

Trial Overview The study tests a less intense treatment regimen using lower doses of radiation therapy combined with chemotherapy for elderly patients. It aims to maintain high cancer control rates while reducing long-term side effects compared to traditional high-dose treatments.

Participant Groups

Group I: Experimental Experimental Treatment 1 Intervention

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

Who Is Running the Clinical Trial?

Omar Mahmoud

Lead Sponsor

Trials

1

Recruited

30+