Personalized Volume-deescalated Elective Nodal Irradiation in Oropharyngeal Head and Neck Squamous Cell Carcinoma
NCT Number: NCT06563362
Acronym: DeEscO
Status: NOT_YET_RECRUITING
Study Type: INTERVENTIONAL
Phases: PHASE2
Conditions: Oropharynx Cancer
Interventions: RADIATION: De-escalation of irradiated volume
Sponsor: University of Zurich
Collaborators: University Hospital Inselspital, Bern|HUG - Hôpitaux universitaires de Genève|Ospedale Regionale di Bellinzona - EOC|Réseau Hospitalier Neuchâtelois|Aarau Cantonal Hospital (KSA)
Sex: ALL
Age: ADULT, OLDER_ADULT
Enrollment: 120
Study Design: Allocation: NA|Intervention Model: SINGLE_GROUP|Masking: NONE|Primary Purpose: TREATMENT
Start Date: 2024-12-01
Completion Date: 2029-12-01

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

Primary Outcome Measures: 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)., from completion of treatment up to 2 years after radiotherapy
Secondary Outcome Measures: 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), 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), 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), 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, 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, 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, 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, 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., 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., >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, 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, 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, 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, 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, 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, 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, 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, at 24 months after the last day of radiotherapy (+/- 2 weeks)
Other Outcome Measures: Assessement of values and longitudinal changes in total blood count, including lymphocytes (explorative assessement), Full blood count will be longitudinally assessed at begin of treatment and at every follow up (descriptive analyses and correlation with all oncological outcomes), Treatment start and every 3 months up to 3 years after radiotherapy