N/A
Completed N=23
Margin-Based Vs. Robust Photon Radiotherapy Planning in IMRT of HN-SQCC
Source: ClinicalTrials.gov NCT03552965 ↗Enrolled (actual)
23
Serious AEs
30.4%
Results posted
May 2025
Primary outcomePrimary: Grade of Xerostomia — 1.14; 1.17 units on a scale
Summary
This is a research study to evaluate the quality of life and amount of dry mouth experienced as a result of radiotherapy in subjects who have squamous cell carcinoma of the head and neck (HN-SQCC). This study will compare the side effects experienced based on the method to plan radiotherapy, Margin Based or Robust.
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Grade of Xerostomia |
2.00; 2.38 | — |
| PRIMARY Prevalence of Xerostomia |
50.75; 38.4375 | — |
Eligibility Criteria
Inclusion Criteria
- Histological documentation of Squamous-Cell Carcinoma of the Head and Neck (HN-SQCC)
- Older than 21 years of age
- Subject is eligible for routine chemo-radiotherapy for treatment of HN-SQCC
- Informed consent is obtained
- Karnofsky performance of at least 70 points
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
- Use of saliva stimulating prescription drugs such as Evoxac or Salagen
- Unable to receive standard chemotherapy
Data sourced from ClinicalTrials.gov (NCT03552965). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication. Informational only — not medical advice.