Oropharynx CancerPhase 2DeEscONCT06563362
Personalized Volume-deescalated Elective Nodal Irradiation in Oropharyngeal Head and Neck Squamous Cell Carcinoma
A Phase 2 study testing De-escalation of irradiated volume in people with Oropharynx Cancer, run by University of Zurich at 7 sites in Switzerland.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Oropharynx Cancer
- What is being tested?
- De-escalation of irradiated volume
- Type of treatment
- Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 120 participants
- Where
- 7 sitesSwitzerland
- Study dates
- 4 Feb 2025to 30 Sep 2030
- Phase
- Phase 2
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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.
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- Participants need to provide informed consent.
- 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.
Who cannot join
- 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.
Trial locations and contacts
7 sites in 1 country. Contact the study team or a site near you to ask about taking part.
7 sites in 1 country
Switzerland7 sites, 7 recruiting
- Recruiting
Cantonal Hospital Aarau
Aarau
Oliver Riesterer, Prof. Dr. med., +41 62 838 42 49, oliver.riesterer@ksa.ch
- Recruiting
Ospedale Regionale di Bellinzona
Bellinzona
Francesco Martucci
- Recruiting
Inselspital Bern
Bern
Olgun Elicin, +41 31 632 26 32, Olgun.Elicin@insel.ch
- Recruiting
Hôpitaux universitaires de Genève
Geneva
Sébastien Tran, Dr. med., +41 22 372 70 90, sebastien.tran@hug.ch
- Recruiting
Réseau Hospitalier Neuchâtelois
Neuchâtel
Sarah Melab, Dr. med., +41 79 559 44 83, sarah.melab@rhne.ch
- Recruiting
Kantonsspital Winterthur
Winterthur
Christoph Oehler, Prof. Dr. med., +41 52 266 26 45, christoph.oehler@ksw.ch
- Recruiting
Zurich University Hospital
Zurich, Canton of Zurich, 8091
Panagiotis Balermpas
About this study
Official title: Personalized Volume-deescalated Elective Nodal Irradiation in Oropharyngeal Head and Neck
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
Read the 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.
- Conditions
- Oropharynx Cancer
- Being tested
- De-escalation of irradiated volume
- Keywords
- head and neck cancer, radiotherapy, elective CTV, clinical target volume, de-escalation
- Medical subject headings
- Oropharyngeal Neoplasms, Head and Neck Neoplasms
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
De-escalation of irradiated volumeRadiation
De-escalation of elective clinical target volumes as recommended by a model-based approach
| Study group | Role | What they receive |
|---|---|---|
| Elective target volume de-escalation arm | Experimental | Target volume de-escalation Receives: Radiation: De-escalation of irradiated volume |
What is being measured
The primary outcome is the main question the study is designed to answer.
out-of field nodal recurrence rate at 2 years
efficacy of personalized CTV-N reduction in oropharyngeal SCC patients 2 years after the end of the primary (chemo)radiotherapy treatment measured by the Kaplan-Meier estimator for the cumulative probability of out-of-field N-site recurrences (incidence of lymph node metastases in non-irradiated LNLs).
Measured: from completion of treatment up to 2 years after radiotherapy
Secondary outcomes (17)
out-of field nodal recurrence rate at 3 years
efficacy of personalized CTV-N reduction in oropharyngeal SCC patients measured by the Kaplan-Meier estimator for the cumulative probability of out-of-field N-site recurrences (incidence of lymph node metastases in non-irradiated LNLs)
Measured: from completion of treatment up to 3 years after radiotherapy
Loco-regional control (LCR) rate at 2 years
assessed by the Kaplan-Meier estimator for the cumulative probability of local recurrence of the primary tumor or recurrence in any cervical LNL (both irradiated and non-irradiated LNLs)
Measured: from completion of treatment up to 2 years after radiotherapy
Loco-regional control (LCR) rate at 3 years
assessed by the Kaplan-Meier estimator for the cumulative probability of local recurrence of the primary tumor or recurrence in any cervical LNL (both irradiated and non-irradiated LNLs)
Measured: from completion of treatment up to 3 years after radiotherapy
Progression-free survival (PFS) at 2 years
assessed by the Kaplan-Meier estimator for the cumulative probability of any local, regional, distant progression or death
Measured: from completion of treatment up to 2 years after radiotherapy
Progression-free survival (PFS) at 3 years
assessed by the Kaplan-Meier estimator for the cumulative probability of any local, regional, distant progression or death
Measured: from completion of treatment up to 3 years after radiotherapy
Overall Survival (OS) at 2 years
assessed by the Kaplan-Meier estimator for the cumulative probability of death from any cause
Measured: from completion of treatment up to 2 years after radiotherapy
Overall Survival (OS) at 3 years
assessed by the Kaplan-Meier estimator for the cumulative probability of death from any cause
Measured: from completion of treatment up to 3 years after radiotherapy
Early toxicity of treatment
assessed by grading of toxicities according to CTCAE v5.0 - overall toxicity will be evaluated according to the TAME methodology.
Measured: treatment start up to 3 months after treatment
Late toxicity of treatment
assessed by grading of toxicities according to CTCAE v5.0 - overall toxicity will be evaluated according to the TAME methodology.
Measured: >3 months up to 3 years after treatment
Overall Quality of life at end of treatment
assessed according to paper-based questionnaires EORTC QLQ C30 All of the scales and single-item measures range in score from 0 to 100. A high scale score A high score for the global health status / QoL represents a high QoL, A high score for a symptom scale / item represents a high level of symptomatology / problems
Measured: at the last day of radiotherapy (+/- 1week)
Quality of life regarding head and neck specific symptoms at end of treatment
assessed according to paper-based questionnaires, i.e. head and neck module HN43: All of the scales and single-item measures range in score from 0 to 100. A high scale score A high score for the global health status / QoL represents a high QoL, A high score for a symptom scale / item represents a high level of symptomatology / problems
Measured: at the last day of radiotherapy (+/- 1week)
Overall Quality of life at 6 months after treatment
assessed according to paper-based questionnaires EORTC QLQ C30: All of the scales and single-item measures range in score from 0 to 100. A high scale score A high score for the global health status / QoL represents a high QoL, A high score for a symptom scale / item represents a high level of symptomatology / problems
Measured: at 6 months after the last day of radiotherapy (+/- 2 weeks)
Quality of life regarding head and neck specific symptoms at 6 months after treatment
assessed according to paper-based questionnaires, i.e. head and neck module HN43: All of the scales and single-item measures range in score from 0 to 100. A high scale score A high score for the global health status / QoL represents a high QoL, A high score for a symptom scale / item represents a high level of symptomatology / problems
Measured: at 6 months after the last day of radiotherapy (+/- 2 weeks)
Overall Quality of life at 12 months after treatment
assessed according to paper-based questionnaires EORTC QLQ C30: All of the scales and single-item measures range in score from 0 to 100. A high scale score A high score for the global health status / QoL represents a high QoL, A high score for a symptom scale / item represents a high level of symptomatology / problems
Measured: at 12 months after the last day of radiotherapy (+/- 2 weeks)
Quality of life regarding head and neck specific symptoms at 12 months after treatment
assessed according to paper-based questionnaires, i.e. head and neck module HN43: All of the scales and single-item measures range in score from 0 to 100. A high scale score A high score for the global health status / QoL represents a high QoL, A high score for a symptom scale / item represents a high level of symptomatology / problems
Measured: at 12 months after the last day of radiotherapy (+/- 2 weeks)
Overall Quality of life at 24 months after treatment
assessed according to paper-based questionnaires EORTC QLQ C30: All of the scales and single-item measures range in score from 0 to 100. A high scale score A high score for the global health status / QoL represents a high QoL, A high score for a symptom scale / item represents a high level of symptomatology / problems
Measured: at 24 months after the last day of radiotherapy (+/- 2 weeks)
Quality of life regarding head and neck specific symptoms at 24 months after treatment
assessed according to paper-based questionnaires, i.e. head and neck module HN43: All of the scales and single-item measures range in score from 0 to 100. A high scale score A high score for the global health status / QoL represents a high QoL, A high score for a symptom scale / item represents a high level of symptomatology / problems
Measured: at 24 months after the last day of radiotherapy (+/- 2 weeks)
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted20 Aug 2024
- Study start4 Feb 2025
- Primary completion30 Sep 2029 (estimated)
- Study completion30 Sep 2030 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Oropharynx CancerStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 2
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 120 participants (estimated)
Sponsor and investigators
- Lead sponsor
- University of Zurich
- Sponsor type
- University, hospital or other
- Collaborators
- Insel Gruppe AG, University Hospital Bern, University Hospital, Geneva, Ospedale Regionale Bellinzona e Valli, Réseau Hospitalier Neuchâtelois, Kantonsspital Aarau, Kantonsspital Winterthur KSW
- Responsible party
- Sponsor
- Investigators
- Panagiotis Balermpas, MD, Principal investigator, University of Zurich
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06563362
- Sponsor's protocol ID
- DeEscO
- Acronym
- DeEscO
- Status last verified
- Oct 2026
- First submitted
- 8 Aug 2024
- Last updated
- 8 Oct 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
Looman EL, Perez Haas Y, Ludwig R, Lauer D, Morand GB, Guckenberger M, Elicin O, Giger R, Tran S, Martucci F, Melab-Belkhodja S, Riesterer O, Benke-Bruderer S, Unkelbach J, Balermpas P. Personalized volume de-escalated elective nodal irradiation in oropharyngeal squamous cell carcinoma (DeEscO): a study protocol. Clin Transl Radiat Oncol. 2026 May 12;59:101182. doi: 10.1016/j.ctro.2026.101182. eCollection 2026 Jul.
PubMed 42200110