MRI - Guided Adaptive RadioTHerapy for Reducing XerostomiA in Head and Neck Cancer (MARTHA-trial)

  • STATUS
    Recruiting
  • End date
    Oct 15, 2023
  • participants needed
    44
  • sponsor
    Panagiotis Balermpas
Updated on 8 May 2021
carcinoma
squamous cell carcinoma
dental caries
x-rays
squamous cell carcinoma of head and neck
intensity-modulated radiation therapy
squamous cell carcinoma of the oral cavity
head and neck carcinoma
mouth cancer
locally advanced squamous cell carcinoma

Summary

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.

Details
Condition head and neck cancer, Xerostomia Due to Radiotherapy, cancer of the head and neck
Treatment Pre-defined MR-linac based IGRT and plan adaptation protocol, salivary flow measurements
Clinical Study IdentifierNCT03972072
SponsorPanagiotis Balermpas
Last Modified on8 May 2021

Eligibility

Yes No Not Sure

Inclusion Criteria

Is your age greater than or equal to 18 yrs?
Gender: Male or Female
Do you have any of these conditions: head and neck cancer or Xerostomia Due to Radiotherapy?
Do you have any of these conditions: Xerostomia Due to Radiotherapy or cancer of the head and neck or head and neck cancer?
Do you have any of these conditions: cancer of the head and neck or Xerostomia Due to Radiotherapy or head and neck cancer?
Do you have any of these conditions: cancer of the head and neck or Xerostomia Due to Radiotherapy or head and neck cancer?
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

Exclusion Criteria

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
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 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.)
Lactating and pregnant women
Previous radiotherapy of the neck
Contraindications for MRI (e.g. pacemaker/ICD, tattoos, cochlear or other not MR-compatible implants)
Pre-existing salivary gland disease (e.g. Sjorgen's-syndrome) or xerostomia-inducing medication (e.g. anticholinergic medication like tricyclic antidepressant)
Claustrophobia
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