Clinical trial · Interventional
Margin-Based Vs. Robust Photon Radiotherapy Planning in IMRT of HN-SQCC
Prospective Randomized Pilot Clinical Trial of Margin-Based Vs. Robust Photon Radiotherapy Planning in Intensity-Modulated Radiation Therapy of Squamous-Cell Carcinoma of the Head and Neck
- Source
- ClinicalTrials.gov
- Retrieved
- Sep 8, 2026
- Layer
- normalized (units and labels harmonized; values unchanged)
- Run
- ING-CLINICALTRIALS-20260908-000001
Summary
Brief summary (as posted)
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.
Conditions
Conditions (1)
Free-text conditions as registered, with the CancerIndex entity they were reconciled to and the match type.
| Condition (as posted) | Mapped entity | Match | Confidence |
|---|---|---|---|
| Squamous Cell Carcinoma of the Head and Neck | Head and Neck Squamous Cell Carcinoma | ALIAS | 0.90 |
Interventions
Interventions (2)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| Margin-Based Radiotherapy planning | Other | — | UNRESOLVED |
| Robust Radiotherapy planning | Other | — | UNRESOLVED |
Design
Arms and outcomes
Arms (2)
- type
- ACTIVE_COMPARATOR
- label
- Margin-Based Radiotherapy Planning
- description
- This arm will receive Intensity-Modulated Radiation Therapy (IMRT) that was calculated by introducing a margin to the target area.
- interventionNames
- Other: Margin-Based Radiotherapy planning
- type
- ACTIVE_COMPARATOR
- label
- Robust Radiotherapy Planning
- description
- This arm will receive Intensity-Modulated Radiation Therapy (IMRT) that was calculated to minimize the dose of radiation to normal tissue.
- interventionNames
- Other: Robust Radiotherapy planning
Primary outcomes (10)
- measure
- Grade of Xerostomia
Eligibility
Eligibility (as posted)
- Sex
- All
- Minimum age
- 21 Years
Show eligibility criteria text
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
References
Publications (0)
Data not yet available