Personalized Reduction of the Irradiated Region (Irradiation Volume) in Throat Cancer (Oropharyngeal Carcinomas)
Summary description of the study
In head and neck cancer, radiation therapy is performed as the standard treatment. The tumor and possible lymph node metastases are irradiated. Additionally, large parts of the neck are irradiated with a slightly lower dose to prevent the future spread of cancer in the body. However, radiation therapy has side effects that increase with the size of the irradiated region and can impair the immune system. In recent years, we have studied the spread of lymph node metastases in about 600 patients. Based on this, we can better estimate tumor spread and the risk of new, yet invisible lymph node metastases. Based on this data and our clinical experience, we have compiled treatment recommendations for the preventively irradiated regions in a table. This way, we can individually reduce the size of the irradiated region with the aim of decreasing the risk of side effects. Only regions with a higher risk of metastasis are irradiated preventively. In this study, we investigate whether this radiation recommendation is safe.
(BASEC)
Intervention under investigation
For each participant, a recommendation for irradiation is developed based on a predefined table. This recommendation is personalized for each participant and is based on the visible individual conditions as well as evaluations from a large dataset. Compared to standard treatment, this study reduces the region that is irradiated preventively. The irradiation lasts 6-7 weeks, followed by regular check-ups up to 3 years after therapy. A total of 18-19 appointments are planned throughout the study duration. The first 7-8 appointments take place before and weekly during irradiation, while the remaining appointments are follow-up visits. In the first two years, these occur every 3 months, then every 6 months. An appointment lasts about 15-30 minutes. Due to the study, the following additional measures are required at some appointments: pregnancy test (if indicated), blood samples (optional), health status questionnaires. Other routine examinations, independent of study participation, include: physical examination, administration of radio-(chemo-)therapy, ultrasound, and imaging using PET-CT or MRI.
(BASEC)
Disease under investigation
Head and Neck Cancer, Oropharyngeal Carcinoma
(BASEC)
1) 18 years or older 2) Newly diagnosed and previously untreated throat cancer (oropharyngeal carcinoma) 3) Indication for primary radiation therapy with curative intent (BASEC)
Exclusion criteria
1) Distant metastases (spread of cancer to other body areas) or tumor recurrence 2) Pregnancy or breastfeeding 3) Other cancer or any other condition that could affect the study (BASEC)
Trial sites
Aarau, Bellinzona, Bern, Geneva, Neuchatel, Zurich
(BASEC)
Sponsor
Universitätsspital Zürich
(BASEC)
Contact
Contact Person Switzerland
Prof. Dr. med. Panagiotis Balermpas
+41 44 255 35 66
panagiotis.balermpas@clutterusz.chUniversitätsspital Zürich Klinik für Radio-Onkologie
(BASEC)
General Information
University of Zurich
+41 44 255 35 67
panagiotis.balermpas@clutterusz.ch(ICTRP)
Name of the authorising ethics committee (for multicentre studies, only the lead committee)
Ethics Committee Zurich
(BASEC)
Date of authorisation
21.01.2025
(BASEC)
ICTRP Trial ID
NCT06563362 (ICTRP)
Official title (approved by ethics committee)
Personalized volume-deescalated elective nodal irradiation in oropharyngeal head and neck squamous cell carcinoma. (BASEC)
Academic title
Personalized Volume-deescalated Elective Nodal Irradiation in Oropharyngeal Head and Neck (ICTRP)
Public title
Personalized Volume-deescalated Elective Nodal Irradiation in Oropharyngeal Head and Neck Squamous Cell Carcinoma (ICTRP)
Disease under investigation
Oropharynx Cancer (ICTRP)
Intervention under investigation
Radiation: De-escalation of irradiated volume (ICTRP)
Type of trial
Interventional (ICTRP)
Trial design
Allocation: N/A. Intervention model: Single Group Assignment. Primary purpose: Treatment. Masking: None (Open Label). (ICTRP)
Inclusion/Exclusion criteria
Inclusion Criteria:
- Patients with a newly diagnosed (no pre-treatment) squamous cell carcinoma of the
oropharynx (i.e. tonsils, base of tongue, oropharyngeal walls, oropharyngeal surface
of epiglottis ICD-10 codes C01, C09, C10), T1-4, N0-3.
- Treatment with definitive (chemo) radiotherapy planned, with elective irradiation of
the lymph nodes.
- Age = 18 years, no upper age limit.
- ECOG performance score < 3.
- History/physical examination within 30 days prior to study inclusion by head and
neck surgeon and/or radiation oncologist.
- FDG-PET scan prior to study inclusion. In case of inability to perform or
contra-indication, at least contrast enhanced MRI scan obligatory.
- Participants need to provide informed consent.
Exclusion Criteria:
Inclusion Criteria:
- Patients with a newly diagnosed (no pre-treatment) squamous cell carcinoma of the
oropharynx (i.e. tonsils, base of tongue, oropharyngeal walls, oropharyngeal surface
of epiglottis ICD-10 codes C01, C09, C10), T1-4, N0-3.
- Treatment with definitive (chemo) radiotherapy planned, with elective irradiation of
the lymph nodes.
- Age = 18 years, no upper age limit.
- ECOG performance score < 3.
- History/physical examination within 30 days prior to study inclusion by head and
neck surgeon and/or radiation oncologist.
- FDG-PET scan prior to study inclusion. In case of inability to perform or
contra-indication, at least contrast enhanced MRI scan obligatory.
- Participants need to provide informed consent.
Exclusion Criteria:
- Multilevel primary tumors extending unambiguously beyond the oropharynx into the
oral cavity, naso- or hypopharynx
- Distant metastases detected.
- Previous surgery, chemotherapy or radiotherapy treatment for other head and neck
cancers.
- Previous surgery in head and neck region affecting the cervical lymphatic system.
Dissection of singular lymph nodes for diagnostic purposes before treatment start is
allowed.
- Synchronous or previous malignancies. Exceptions are curatively treated basal cell
carcinoma or SCC of the skin, or in situ carcinoma of the cervix uteri, low- or
intermediate- risk prostate cancer or breast with a progression-free follow-up time
of at least 3 years without any remaining disease burden, or other previous
malignancy with a progression-free interval of at least 5 years without any
remaining active/progressive disease burden regardless whether the treatment is
completed or ongoing as a maintenance treatment (e.g. androgen deprivation therapy
for prostate cancer).
- Pregnancy or breast feeding
- Any severe mental or psychic disorder affecting decision making and ability to
provide informed consent. (ICTRP)
not available
Primary and secondary end points
out-of field nodal recurrence rate at 2 years (ICTRP)
out-of field nodal recurrence rate at 3 years;Loco-regional control (LCR) rate at 2 years;Loco-regional control (LCR) rate at 3 years;Progression-free survival (PFS) at 2 years;Progression-free survival (PFS) at 3 years;Overall Survival (OS) at 2 years;Overall Survival (OS) at 3 years;Early toxicity of treatment;Late toxicity of treatment;Overall Quality of life at end of treatment;Quality of life regarding head and neck specific symptoms at end of treatment;Overall Quality of life at 6 months after treatment;Quality of life regarding head and neck specific symptoms at 6 months after treatment;Overall Quality of life at 12 months after treatment;Quality of life regarding head and neck specific symptoms at 12 months after treatment;Overall Quality of life at 24 months after treatment;Quality of life regarding head and neck specific symptoms at 24 months after treatment (ICTRP)
Registration date
not available
Incorporation of the first participant
not available
Secondary sponsors
Insel Gruppe AG, University Hospital Bern;University Hospital, Geneva;Ospedale Regionale Bellinzona e Valli;R�seau Hospitalier Neuch�telois;Kantonsspital Aarau (ICTRP)
Additional contacts
Panagiotis Balermpas, MDPanagiotis Balermpas, MD, Panagiotis.Balermpas@usz.ch, +41 44 255 35 67, University of Zurich (ICTRP)
Secondary trial IDs
DeEscO (ICTRP)
Results-Individual Participant Data (IPD)
not available
Further information on the trial
https://clinicaltrials.gov/ct2/show/NCT06563362 (ICTRP)
Results of the trial
Results summary
not available
Link to the results in the primary register
not available