Robust vs. Margin-Based Radiotherapy for Head and Neck Cancer
What You Need to Know Before You Apply
What is the purpose of this trial?
This trial explores how two methods of planning radiotherapy affect quality of life and dry mouth in people with squamous cell carcinoma of the head and neck. It compares Margin-Based Radiotherapy, which includes a buffer area around the target, with Robust Radiotherapy, which minimizes radiation to healthy tissue. People diagnosed with this type of cancer and eligible for standard chemo-radiotherapy may be a good fit. The goal is to determine which method leads to fewer side effects, improving patients' daily lives. As an unphased trial, this study allows patients to contribute to research that could enhance future treatment options.
Do I need to stop my current medications for the trial?
The trial requires that you stop using saliva-stimulating prescription drugs like Evoxac or Salagen. Other medications are not specifically mentioned, so it's best to discuss with the trial team.
What prior data suggests that these radiotherapy planning methods are safe for head and neck cancer patients?
Research has shown that both robust and margin-based radiotherapy are generally safe for treating head and neck cancer. Early results suggest that robust radiotherapy, such as intensity-modulated radiation therapy (IMRT), effectively controls tumors and results in fewer long-term side effects than expected. This method reduces radiation exposure to normal tissues, helping to minimize side effects.
Studies on margin-based radiotherapy indicate it effectively targets cancer while adjusting for changes in tumor size or position during treatment. It uses a planning margin to ensure sufficient radiation reaches the cancer while protecting nearby healthy tissues.
Both methods prioritize precision and safety. Research supports their tolerance by patients with head and neck cancer. However, like any treatment, some side effects can occur, so discussing potential risks with a doctor is important.12345Why are researchers excited about this trial?
Researchers are excited about this trial because it explores two innovative approaches to radiotherapy for head and neck cancer. Unlike traditional methods that often risk exposing healthy tissue to radiation, the robust radiotherapy planning technique is designed to minimize radiation exposure to normal tissues, potentially reducing side effects. Meanwhile, the margin-based radiotherapy planning involves adding a margin around the target area, which could improve accuracy in targeting cancer cells. This trial aims to find out which method is more effective at delivering precise treatment while sparing healthy tissue, offering hope for more efficient and safer treatment options.
What evidence suggests that this trial's radiotherapy planning methods could be effective for head and neck cancer?
This trial will compare Robust Radiotherapy Planning with Margin-Based Radiotherapy Planning for head and neck cancer. Research has shown that a strong radiotherapy plan, like the robust method, can effectively control head and neck cancer by ensuring even distribution of the radiation dose. This approach improves tumor coverage by 5.8% and reduces unnecessary radiation to healthy tissues. Studies indicate that this type of planning reliably targets the cancer while minimizing harm to surrounding areas, potentially leading to better outcomes.
In this trial, the Margin-Based Radiotherapy Planning arm will use a slightly different method. This approach involves adding extra space around the tumor to ensure it receives the necessary dose, even with slight movement. While it provides good coverage, it may not reduce radiation to healthy tissues as effectively as the robust planning method. Both methods aim to treat cancer effectively, but they differ in managing radiation exposure to nearby healthy tissues.16789Who Is on the Research Team?
Mausam Patel, MD
Principal Investigator
University of Arkansas
Are You a Good Fit for This Trial?
This trial is for adults over 21 with a type of cancer called HN-SQCC, who are fit enough for standard chemo-radiotherapy. They must be able to follow the study procedures and not use certain saliva-stimulating drugs. Pregnant or breastfeeding women cannot participate unless they agree to use contraception.Inclusion Criteria
Exclusion Criteria
Timeline for a Trial Participant
Screening
Participants are screened for eligibility to participate in the trial
Treatment
Participants receive Intensity-Modulated Radiation Therapy (IMRT) with either margin-based or robust radiotherapy planning, along with standard chemotherapy
Follow-up
Participants are monitored for xerostomia and quality of life using questionnaires at 3, 6, 9, and 12 months after radiotherapy
What Are the Treatments Tested in This Trial?
Interventions
- Margin-Based Radiotherapy planning
- Robust Radiotherapy planning
Find a Clinic Near You
Who Is Running the Clinical Trial?
University of Arkansas
Lead Sponsor