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

What You Need to Know Before You Apply

What is the purpose of this trial?

This trial explores a new method to treat oropharyngeal cancer, which affects the throat area, using lower doses of radiation combined with chemotherapy. The aim is to determine if this approach can control the cancer as effectively as traditional high-dose treatments but with fewer long-term side effects. Individuals with a specific type of this cancer, located in the throat and neck, who have not received previous treatments, might be ideal candidates for this trial. Participants will undergo a modified schedule of radiation (intensity modulated radiotherapy) and weekly chemotherapy to assess its effectiveness and side effect profile. As an unphased trial, this study provides a unique opportunity for patients to contribute to innovative research that could lead to more effective and less harmful cancer treatments.

Will I have to stop taking my current medications?

The trial information does not specify whether you need to stop taking your current medications. It's best to discuss this with the trial coordinators or your doctor.

What prior data suggests that this modified radiotherapy is safe for oropharyngeal cancer patients?

Research has shown that using lower doses of intensity-modulated radiation therapy (IMRT) with chemotherapy might reduce side effects for patients with oropharyngeal cancer. Previous studies have found IMRT effective in treating cancer, but it often causes many side effects, especially at high doses.

One study comparing different radiation treatments found that patients who received IMRT experienced fewer side effects than those who received other types of radiation. This suggests that lower doses of IMRT can still effectively control cancer while possibly causing fewer side effects.

This finding is encouraging for those concerned about the severe side effects of traditional high-dose treatments. However, it is important to note that while lower doses may be gentler on the body, they are still under study to ensure both effectiveness and safety. ^{1 2 3 4 5}

Why are researchers excited about this trial?

Modified radiotherapy for oropharyngeal cancer is unique because it combines a tailored radiation dose with precise delivery techniques like Intensity Modulated Radiation Therapy (IMRT) and Image-Guided Radiation Therapy (IGRT). Unlike traditional treatments that use a standard radiation approach, this method aims to minimize damage to healthy tissues by adjusting the radiation dose and targeting the cancer more accurately. Researchers are excited about this treatment because it includes weekly doses of cisplatin, a chemotherapy drug, which is expected to enhance the effectiveness of the radiation. The combination of these advanced technologies and precise dosing could potentially improve patient outcomes and reduce side effects compared to standard treatments.

What evidence suggests that this modified radiotherapy is effective for oropharyngeal cancer?

Research has shown that intensity-modulated radiation therapy (IMRT) combined with chemotherapy can effectively treat oropharyngeal cancer. In this trial, participants will receive IMRT with Cisplatin chemotherapy. Studies have found that up to 98.4% of patients remain alive two years after treatment with IMRT, either alone or with other therapies. By using lower doses and targeting smaller areas with radiation, this method aims to control cancer effectively while reducing side effects. As a result, patients might experience fewer long-term health problems compared to more intense treatments. This approach seeks to balance effective cancer treatment with a better quality of life during and after treatment. ^{2 3 4 5 6}

Are You a Good Fit for This Trial?

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 for a Trial Participant

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

What Are the Treatments Tested in This Trial?

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.

How Is the Trial Designed?

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+

Citations

1. pmc.ncbi.nlm.nih.gov pmc.ncbi.nlm.nih.gov/articles/PMC3479880/

Clinical evaluation of intensity-modulated radiotherapy for ... The overall survival at 5 years for Stage III and IV laryngeal cancers using the most aggressive chemoradiation approaches is only 50–60%. Escalation of ...

2. jamanetwork.com jamanetwork.com/journals/jamanetworkopen/fullarticle/2798320

Toxicity Profiles and Survival Outcomes Among Patients ... This cohort study compares the toxic effects and oncologic outcomes associated with intensity-modulated radiation therapy (IMRT) vs ...

3. sciencedirect.com sciencedirect.com/science/article/abs/pii/S036030160500708X

Intensity-modulated radiation therapy (IMRT) of cancers ... The calculated mean volume receiving >110% for all patients planned with WF-IMRT was 9.3% (0.8%–25%) compared to 13.7% (2.7%–23.7%) with HB-IMRT (p = 0.09). The ...

4. link.springer.com link.springer.com/article/10.1007/s42399-023-01562-5

Clinical Efficacy and Complications of Intensity-modulated ... Based on data from November 2022, the 5-year overall survival (OS) for OPC is reported to be 61.3% [5]. Intensity-modulated radiation therapy ( ...

5. mdpi.com mdpi.com/2072-6694/13/7/1549

Early Clinical Outcomes of Intensity Modulated Radiation ... Among all patients, the 2-year OS rates were 92.1% and 98.4% in the IMRT only and IMRT/IMPT combination groups (p = 0.235), and the 2-year PFS rates were 76.2% ...

6. pmc.ncbi.nlm.nih.gov pmc.ncbi.nlm.nih.gov/articles/PMC8037748/

Early Clinical Outcomes of Intensity Modulated Radiation ... Purpose: To report the early clinical outcomes of combining intensity-modulated radiation therapy (IMRT) and intensity-modulated proton therapy (IMPT) in ...