Robust vs. Margin-Based Radiotherapy for Head and Neck Cancer

Overseen By Aaron Holley

Age: 18+

Sex: Any

Trial Phase: Academic

Sponsor: University of Arkansas

Must not be taking: Saliva stimulants

Disqualifiers: Pregnancy, Non-compliance, Chemo intolerance, others

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

Compensation: Varies

Number of Visits: 4

Duration: 6-8 weeks

50 Participants Needed

Trial Summary

What is the purpose of this trial?

This trial compares two radiotherapy planning methods in head and neck cancer patients to see which one causes fewer side effects like dry mouth. The results will help design future studies.

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 data supports the effectiveness of Margin-Based Radiotherapy and Robust Radiotherapy planning for head and neck cancer treatment?

Research shows that using robust optimization techniques in radiotherapy can improve the accuracy of targeting cancer cells while reducing the exposure of healthy tissues to radiation. This approach helps ensure that the treatment is more precise and potentially more effective for head and neck cancer patients. ^{1 2 3 4 5}

Is radiotherapy for head and neck cancer safe for humans?

The research articles focus on optimizing radiotherapy techniques for head and neck cancer, but they do not provide specific safety data for humans. They discuss treatment planning and setup errors, but not direct safety outcomes. ^{2 3 4 6 7}

How does robust vs. margin-based radiotherapy differ from other treatments for head and neck cancer?

Robust radiotherapy planning focuses on maximizing the probability of controlling the tumor by ensuring a consistent dose distribution, even if there are small changes in patient positioning or anatomy during treatment. This approach is different from traditional margin-based radiotherapy, which relies on adding extra space around the tumor to account for these uncertainties, potentially exposing more healthy tissue to radiation. ^{1 2 3 4 8}

Research Team

Mausam Patel, MD

Principal Investigator

University of Arkansas

Eligibility Criteria

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

My cancer is a type of squamous-cell carcinoma located in the head or neck.

I am over 21 years old.

I am able to care for myself but cannot do normal activities or work.

Exclusion Criteria

Women with a positive urine pregnancy test are excluded from this study; women of childbearing potential must agree to refrain from breast feeding and practice adequate contraception

Unable to comply with study procedures

I cannot undergo standard chemotherapy.

Timeline

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

Treatment

Participants receive Intensity-Modulated Radiation Therapy (IMRT) with either margin-based or robust radiotherapy planning, along with standard chemotherapy

6-8 weeks

Follow-up

Participants are monitored for xerostomia and quality of life using questionnaires at 3, 6, 9, and 12 months after radiotherapy

12 months

4 visits (in-person or virtual)

Treatment Details

Interventions

• Margin-Based Radiotherapy planning
• Robust Radiotherapy planning

Trial Overview The study compares two radiotherapy planning methods for treating head and neck cancer: Margin-Based and Robust planning. It aims to see which method results in better quality of life and less dry mouth after treatment.

Participant Groups

Group I: Robust Radiotherapy Planning Active Control 1 Intervention

This arm will receive Intensity-Modulated Radiation Therapy (IMRT) that was calculated to minimize the dose of radiation to normal tissue.

Group II: Margin-Based Radiotherapy Planning Active Control 1 Intervention

This arm will receive Intensity-Modulated Radiation Therapy (IMRT) that was calculated by introducing a margin to the target area.

Who Is Running the Clinical Trial?

University of Arkansas

Lead Sponsor

Trials

500

Recruited

153,000+

Findings from Research

A study involving 100 patients with head-and-neck cancer used cine MR imaging to measure tumor motion during radiotherapy, revealing that the average maximum tumor motion was less than 3.0 mm, but varied significantly among patients (0.1-12.0 mm).

Based on the quantified tumor motion, population-based planning target volume (PTV) margins were established, with specific margins of 2.8 mm for nasopharyngeal tumors, 3.2 mm for oropharyngeal tumors, and 4.3 mm in the inferior-superior direction for laryngeal tumors, ensuring more accurate targeting during treatment.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Intrafraction motion quantification and planning target volume margin determination of head-and-neck tumors using cine magnetic resonance imaging. Bruijnen, T., Stemkens, B., Terhaard, CHJ., et al.[2019]

References

1. Ireland pubmed.ncbi.nlm.nih.gov

Intrafraction motion quantification and planning target volume margin determination of head-and-neck tumors using cine magnetic resonance imaging. [2019]

2. England pubmed.ncbi.nlm.nih.gov

Assessment of residual setup errors for anatomical sub-structures in image-guided head-and-neck cancer radiotherapy. [2014]

3. England pubmed.ncbi.nlm.nih.gov

Estimation of adequate setup margins and threshold for position errors requiring immediate attention in head and neck cancer radiotherapy based on 2D image guidance. [2022]

4. Ireland pubmed.ncbi.nlm.nih.gov

Composite minimax robust optimization of VMAT improves target coverage and reduces non-target dose in head and neck cancer patients. [2020]

5. Ireland pubmed.ncbi.nlm.nih.gov

Analysis of the motion of oropharyngeal tumors and consequences in planning target volume determination. [2008]

6. Ireland pubmed.ncbi.nlm.nih.gov

PTV-based VMAT vs. robust IMPT for head-and-neck cancer: A probabilistic uncertainty analysis of clinical plan evaluation with the Dutch model-based selection. [2023]

7. Ireland pubmed.ncbi.nlm.nih.gov

Toward a model-based patient selection strategy for proton therapy: External validation of photon-derived normal tissue complication probability models in a head and neck proton therapy cohort. [2022]

8. Netherlands pubmed.ncbi.nlm.nih.gov

Robust maximization of tumor control probability for radicality constrained radiotherapy dose painting by numbers of head and neck cancer. [2022]