NCT03972072Completed
MRI - Guided Adaptive RadioTHerapy for Reducing XerostomiA in Head and Neck Cancer (MARTHA-trial)
MARTHA-trial: MRI - Guided Adaptive RadioTHerapy for Reducing XerostomiA in Head and Neck Cancer Including Longitudinal Evaluation of the Patient's Immune Profile Under Radiotherapy
Source: ClinicalTrials.gov · Last updated 3 Aug 2026
Brief summary (registry, in English)
Radiotherapy is the main treatment for locally advanced squamous cell carcinoma of the head and neck (SCCHN). Many advances regarding tumor control and patient survival have been made over the past decades. However, treatment-induced toxicity remains a crucial problem, leading to reduced quality of life and permanent impairment for many survivors. Xerostomia is up to this day the leading cause of late toxicity for these patients. Toxicity has been reduced by implementation of modern image guided radiotherapy (IGRT) and intensity-modulated radiotherapy (IMRT), but the low soft-tissue contrast of routine x-ray image guidance does not allow exact planning adaptation and daily imaging is associated with high radiation exposure. Furthermore, despite the routinely use of IMRT, rates of clinically relevant xerostomia (i.e. grade 2 or worse) are still common and reported in approximately 38%. Recently developed hybrid machines (MRidian®-CE approval since 2016), consisting of a linear accelerator and an integrated low-field MRI, could allow a) better visualization of tumor and organs at risk, such as parotid glands during patient positioning and daily treatment, b) daily imaging without additional radiation exposure, c) narrowest established safety margins for the treatment volumes, and finally d) repetitive adaptation of target volumes according to changes in patient weight and tumor anatomy during the radiotherapy course. These procedures would facilitate a high-precision treatment and help reduce dose exposure of critical structures.
- Status (registry)
- Completed
- Study type
- Interventional
- Enrollment
- 49 (actual)
- First submitted
- 23 May 2019
- Start date
- Oct 2019
- Primary completion date
- May 2025
- Lead sponsor
- Panagiotis Balermpas
- Diseases
- Head and neck cancer
- NCT number
- NCT03972072
What you commit to
- Study type: Interventional
- Participants enrolled: 49
- From Oct 2019 to the primary completion date, May 2025
- 1 site in 1 country
- Visits and tests: ask the trial team, the registry does not list them
Built from the registry fields of ClinicalTrials.gov. It describes the study, not your situation.
Who cannot take part
Copied verbatim from ClinicalTrials.gov and grouped by topic. Only the trial team decides who can take part.
Prior treatment
- Other severe comorbidities or psychic disorders (e.g. myocardial infraction within 6 months prior to registration, permanent cardiac arrhythmia, COPD Gold IV, hepatitis B/C, schizophrenia, ongoing alcohol abuse etc.)
- Previous radiotherapy of the neck
- Contraindications for MRI (e.g. pacemaker/ICD, tattoos, cochlear or other not MR-compatible implants)
Other illness
- Not adequately controlled hepatitis or HIV disease (HIV-viral load detectable)
- Second non-controlled malignancy other than basalioma or cervical/genital/anal in situ neoplasia during the last 2 years before enrollment
- Pre-existing salivary gland disease (e.g. Sjorgen's-syndrome) or xerostomia-inducing medication (e.g. anticholinergic medication like tricyclic antidepressant)
Lab values
- Bilirubin \> 2,0 mg/dl, SGOT, SGPT, AP, Gamma-GT \>3x norm, GFR \< 30 ml/min
- leucocytes \<3,5 x 10\^9/l or platelets \< 100 x 10\^9/l or neutrophiles \< 1,5 x 10\^9/l
Other
- Lactating and pregnant women
- Claustrophobia
Who the study is looking for
- Histologically proven squamous cell carcinoma of the oral cavity oro- or hypopharynx or larynx, Stages II-IVB, requiring definitive or postoperative bilateral neck irradiation
- Age ≥ 18 years, no upper age limit
- ECOG-Performance score \< 2
- The trial is open to both genders
- History/physical examination within 30 days prior to registration by head and neck surgeon and Radiation Oncologist
- FDG-PET-CT-scan within 30 days prior to registration
Age in the registry: 18 years to - · Sex: All · Does not accept healthy volunteers
Sites (1)
Sites in registry order. Pick your city on the disease page to sort them by distance.
| Site | City | Country | Site status |
|---|---|---|---|
| Zurich University Hospital Coordinator of this site? Confirm its status | Zurich | Switzerland | Unknown status |
This page is information, not medical advice. Discuss any trial with your doctor.