Eligibility Module
The Eligibility Module contains detailed information about who can participate in the clinical trial. This includes eligibility criteria, age restrictions, gender requirements, healthy volunteer status, and study population descriptions, helping researchers understand who is eligible to participate in the study.
Eligibility Module path is as follows:
Study -> Protocol Section -> Eligibility Module
Eligibility Module
Ignite Creation Date:
2025-12-24 @ 5:39 PM
Ignite Modification Date:
2025-12-24 @ 5:39 PM
NCT ID:
NCT03981068
Eligibility Criteria:
Inclusion Criteria:
* Histological verified loco-regional recurrence or new primary
* Available dose plan from primary radiotherapy course
* Comparative dose plan with advantages for proton radiotherapy e.g. integral dose
* Dmax dose (0.03 cm3) on the cumulated photon dose planā„90 Gy
* Complete Response (CR)\* after initial therapy, except in the case where the recurrence is considered a geometric miss (recurrence center of mass (COM) outside the 95% of prescription dose.
* Inoperable or salvage surgery with R1/R2 resection, extranodal extension (ENE) or extensive soft tissue infiltration
* Absence of distant metastasis at both
* clinical examination AND
* PET-CT or CT of thorax and upper abdomen
* Life expectancy due to age and co-morbidity of \>=1 year. The general condition must be sufficient to tolerate persistent significant side effects, e.g. tube or cannulae
* PS\<=2 (WHO See appendix)
Exclusion Criteria:
* Radical surgery (R0) and absence of adverse prognostic pathological features
* Lymphoma or malignant melanoma
* Inability to attend full course of radiotherapy or follow-up visits in the outpatient clinic
* As of 2019, patients with tracheal cannulas are excluded due to dose uncertainties. This may change if a technical solution becomes available.
Healthy Volunteers:
False
Sex:
ALL
Minimum Age:
18 Years
Study:
NCT03981068
Study Brief:
Protocol Section:
NCT03981068