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

Studien-Informationen Einschlusskriterien Studien-Rationale Geprüfte Regime

Rekrutierend

NCT-Nummer:
NCT03972072

Studienbeginn:
Oktober 2019

Letztes Update:
29.11.2023

Wirkstoff:
-

Indikation (Clinical Trials):
Head and Neck Neoplasms, Xerostomia

Geschlecht:
Alle

Altersgruppe:
Erwachsene (18+)

Phase:
-

Sponsor:
Panagiotis Balermpas

Collaborator:
-

Studienleiter

Panagiotis Balermpas, M.D.
Principal Investigator
University Hospital Zurich, Department of Radiation-Oncology

Kontakt

Panagiotis Balermpas, M.D.
Kontakt:
Phone: +41 44 255 35 67
E-Mail: panagiotis.balermpas@usz.ch» Kontaktdaten anzeigen

Studienlocations
(1 von 1)

Zurich University Hospital
8091 Zurich
SwitzerlandRekrutierend» Google-Maps
Ansprechpartner:
Panagiotis Balermpas, M.D.
Phone: +41797493375
E-Mail: rao_akademischesoffice@usz.ch

Debra Fesslmeier
Phone: +41432530151
E-Mail: rao_akademischesoffice@usz.ch» Ansprechpartner anzeigen

Studien-Informationen

Brief 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.

Ein-/Ausschlusskriterien

Inclusion Criteria:

- 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

Studien-Rationale

Primary outcome:

1. Percentage of patients with xerostomia of grade 2 or worse (Time Frame - 12 month-follow up):
will be evaluated by the LENT-SOMA (Late Effects Normal Tissue Task Force (LENT)-Subjective, Objective, Management, Analytic (SOMA)) side-effect scale: SOM (1)-(4) (higher score represents higher grade xerostomia), A: objective flow measurement (1) 76-95%, (2) 51-75%, (3) 26-50%, (4) 0-25%

Secondary outcome:

1. Percentage of patients with xerostomia of grade 2 or worse (Time Frame - 6- and 24-months follow up):
will be evaluated by the LENT-SOMA (Late Effects Normal Tissue Task Force (LENT)-Subjective, Objective, Management, Analytic (SOMA)) side-effect scale: SOM (1)-(4) (higher score represents higher grade xerostomia), A: objective flow measurement (1) 76-95%, (2) 51-75%, (3) 26-50%, (4) 0-25%

2. Locoregional control rate as defined from treatment start to histologically confirmed tumor progression, persistence or last follow up (Time Frame - 2-years):
as defined from treatment start to histologically confirmed tumor progression, persistence or last follow up

3. Overall survival (Time Frame - 2-years):
as defined from treatment start to death from any cause or last follow up

4. Description of Quality of life - scoring 6 months after treatment, assessed according to the general EORTC-quality of life "core" questionnaire QLQ C30 (overall quality of life for cancer patients) (Time Frame - 6 months after treatment):
Questionnaire consists of 30 questions with a maximal score of 100. Absolute scores after linear transformation will be reported as descriptive statistics The QLQ-C30 is composed of both multi-item scales and single-item measures. These include five functional scales, three symptom scales, a global health status / QoL scale, and six single items. Each of the multi-item scales includes a different set of items - no item occurs in more than one scale. All of the scales and single-item measures range in score from 0 to 100. A high scale score represents a higher response level. A high score for a functional scale represents a high / healthy level of functioning, a high score for the global health status / QoL represents a high QoL, but a high score for a symptom scale / item represents a high level of symptomatology / problems. See also: https://www.eortc.org/app/uploads/sites/2/2018/02/SCmanual.pdf

5. Description of Head-Neck cancer related symptoms 6 months after treatment, assessed according to the specific EORT-head and neck quality of life supplementary questionnaire HN35 (Time Frame - 6 months after treatment):
total scoring of an additional 35 questions with a similar approach to that of the core questionnaire will be reported as descriptive statistics

6. Description of Quality of life - scoring 12 months after treatment, assessed according to the general EORTC-quality of life "core" questionnaire QLQ C30 (overall quality of life for cancer patients) (Time Frame - 12 months after treatment):
Questionnaire consists of 30 questions with a maximal score of 100. Absolute scores after linear transformation will be reported as descriptive statistics The QLQ-C30 is composed of both multi-item scales and single-item measures. These include five functional scales, three symptom scales, a global health status / QoL scale, and six single items. Each of the multi-item scales includes a different set of items - no item occurs in more than one scale. All of the scales and single-item measures range in score from 0 to 100. A high scale score represents a higher response level. A high score for a functional scale represents a high / healthy level of functioning, a high score for the global health status / QoL represents a high QoL, but a high score for a symptom scale / item represents a high level of symptomatology / problems. See also: https://www.eortc.org/app/uploads/sites/2/2018/02/SCmanual.pdf

7. Description of Head-Neck related symptoms 12 months after treatment, assessed according to the specific EORT-head and neck quality of life supplementary questionnaire HN35 (Time Frame - 12 months after treatment):
total scoring of an additional 35 questions with a similar approach to that of the core questionnaire will be reported as descriptive statistics

8. Description of Quality of life - scoring 24 months after treatment, assessed according to the general EORTC-quality of life "core" questionnaire QLQ C30 (overall quality of life for cancer patients) (Time Frame - 24 months after treatment):
Questionnaire consists of 30 questions with a maximal score of 100. Absolute scores after linear transformation will be reported as descriptive statistics The QLQ-C30 is composed of both multi-item scales and single-item measures. These include five functional scales, three symptom scales, a global health status / QoL scale, and six single items. Each of the multi-item scales includes a different set of items - no item occurs in more than one scale. All of the scales and single-item measures range in score from 0 to 100. A high scale score represents a higher response level. A high score for a functional scale represents a high / healthy level of functioning, a high score for the global health status / QoL represents a high QoL, but a high score for a symptom scale / item represents a high level of symptomatology / problems. See also: https://www.eortc.org/app/uploads/sites/2/2018/02/SCmanual.pdf

9. Description of Head-Neck related symptoms 24 months after treatment, assessed according to the specific EORT-head and neck quality of life supplementary questionnaire HN35 (Time Frame - 24 months after treatment):
total scoring of an additional 35 questions with a similar approach to that of the core questionnaire will be reported as descriptive statistics

10. Toxicity rates (Time Frame - weekly during radiotherapy and at 3, 6, 9, 12, 15, 18, 21 and 24 months):
evaluated by the CTCAE v5-questionnaires

Geprüfte Regime

Pre-defined MR-linac based IGRT and plan adaptation protocol:
daily MR-imaging/MR guided radiotherapy once weekly offline plan adaptation to a total of 6
salivary flow measurements:
baseline, 6 month-, 12 month- and 24 month-follow up salivary flow measurements and LENT-SOMA subjective/objective evaluation of xerostomia

Quelle: ClinicalTrials.gov

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