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Trial Title:
Personalized Volume-deescalated Elective Nodal Irradiation in Oropharyngeal Head and Neck Squamous Cell Carcinoma
NCT ID:
NCT06563362
Condition:
Oropharynx Cancer
Conditions: Official terms:
Oropharyngeal Neoplasms
Conditions: Keywords:
head and neck cancer
radiotherapy
elective CTV
clinical target volume
de-escalation
Study type:
Interventional
Study phase:
Phase 2
Overall status:
Not yet recruiting
Study design:
Allocation:
N/A
Intervention model:
Single Group Assignment
Primary purpose:
Treatment
Masking:
None (Open Label)
Intervention:
Intervention type:
Radiation
Intervention name:
De-escalation of irradiated volume
Description:
De-escalation of elective clinical target volumes as recommended by a model-based
approach
Arm group label:
Elective target volume de-escalation arm
Summary:
Multicentric prospective model-based de-escalation of the elective clinical target
volumes (CTV) in radiotherapy of oropharyngeal carcinoma of all stages with the goal to
reduce toxicity.
The study investigates the feasibility of this approach as measured by the number of
expected out-of-field recurrencies based on the individual patient's state of disease
progression and risk factors
Detailed description:
Local treatment of squamous cell carcinoma (SCC) of the oropharynx can consist of
surgery, radiotherapy, or a combination of both. When treated with radiation, the target
volume contains not only the primary tumor and clinically detected lymph node metastases.
In addition, a large part of the lymph drainage system of the neck which is at risk of
harboring occult metastases is irradiated, the so called "elective clinical target volume
(CTV)". This elective CTV is currently based on clinical recommendations, but there is
limited data and evidence on (occult) lymphatic spread and the required size of the
elective CTV. This standard radiotherapy approach is associated with early and late
toxicity. Toxicities such as pain, dermatitis, mucositis, but also long-term sequela like
swallowing dysfunction, lymphedema and dysgeusia are commonly described, which can even
lead to hospitalization or long-term symptoms with subsequent life-quality impairment.
A de-escalation of the treatment could result in less toxicity. Multiple studies have
evaluated potential ways to de-escalate treatment and reduce toxicity, such as dose
reduction or change of chemotherapeutic agent. Another possible de-escalation strategy,
which is pursued here, is to reduce the elective clinical target volume.
A multi-institutional dataset of 598 oropharyngeal SCC patients in whom the detailed
patterns of lymph node involvement are reported was collected. The publicly available
online platform www.LyProX.org was developed to share and visualize the data. Based on
this data, a statistical model of lymphatic tumor progression to perform a statistical
analysis to estimate the probability of occult metastases in the clinically negative
lymph node levels was developed. The patient's state of metastatic lymphatic progression
is described via a hidden Markov model. The state of tumor progression is described by a
collection of hidden binary random variables that indicate the involvement of lymph node
levels. The model parameters are the probabilities for the tumor to spread to and between
lymph node levels and are learned from the dataset. Supporting clinical experience, these
statistical calculations can subsequently be used as a basis, to personalize the risk
estimation of occult lymph node metastases in newly diagnosed patients based on their
distribution of macroscopic metastases, T-stage, and lateralization of the primary tumor.
A table with the possible different combinations of clinically observed lymph node
involvement and the associated risk of occult lymph node involvement in the remaining,
clinically negative lymph node levels (LNL) was created. By interpreting the results from
both the statistical analysis and clinical experience, the elective clinical target
volume (CTV) was personalized based on a patient's individualized risk profile. As a
final measure of quality assurance, the elective CTVs (CTV-3s) constructed in this way
have been discussed individually by the investigators, to ensure consistency with data
and clinical judgement and experience. This leads to a reduction of irradiated volume
and, potentially, to a reduction in early and late toxicity.
The aim of this clinical trial is to determine the safety of the use of a personalized
de-escalated elective nodal CTV in oropharynx SCC patients treated with primary
(chemo)radiotherapy.
Criteria for eligibility:
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.
Gender:
All
Minimum age:
18 Years
Maximum age:
N/A
Healthy volunteers:
No
Start date:
December 1, 2024
Completion date:
December 1, 2029
Lead sponsor:
Agency:
University of Zurich
Agency class:
Other
Collaborator:
Agency:
University Hospital Inselspital, Bern
Agency class:
Other
Collaborator:
Agency:
HUG - Hôpitaux universitaires de Genève
Agency class:
Other
Collaborator:
Agency:
Ospedale Regionale di Bellinzona - EOC
Agency class:
Other
Collaborator:
Agency:
Réseau Hospitalier Neuchâtelois
Agency class:
Other
Collaborator:
Agency:
Aarau Cantonal Hospital (KSA)
Agency class:
Other
Source:
University of Zurich
Record processing date:
ClinicalTrials.gov processed this data on November 12, 2024
Source: ClinicalTrials.gov page:
https://clinicaltrials.gov/ct2/show/NCT06563362
