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Summary Design Phase II observational
Treatment
60 Gy/50 fx / 10W-1 at 1.2 Gy/fx
o i.e. EQD2 tumor=56 Gy, EQD2 late=50.4 Gy at α/β= 10 and 3, respectively
Proton radiotherapy
Concomitant cisplatin for eligible patients*
Nimorazole recommended for SCC* *The concurrent medical treatment (weekly cisplatin and nimorazole) are prescribed according to the national treatment guidelines, and are not part of the experimental treatment.
Endpoints
Primary:
o Any new late toxicity grade >=3 according to CTC AE 5.0
Secondary
Full description
Summary Design Phase II observational 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 plan≥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
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)
The patients should be able to read Danish in order to participate with quality of life questionnaires, but can participate in the rest of the protocol without being fluent in Danish, if capable of reading the patient information.
* Complete Response is defined as the situation when a trained clinician, ideally at a multidisciplinary team conference, defines the patient as in complete remission, based on clinical examination and available imaging. This status can of course later be considered wrong as new information becomes available (sub-centimeter nodes grow etc.) 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.
Treatment
60 Gy/50 fx / 10W-1 at 1.2 Gy/fx
o i.e. EQD2 tumor=56 Gy, EQD2 late=50.4 Gy at α/β= 10 and 3, respectively
Proton radiotherapy
Concomitant cisplatin for eligible patients*
Nimorazole recommended for SCC* *The concurrent medical treatment (weekly cisplatin and nimorazole) are prescribed according to the national treatment guidelines, and are not part of the experimental treatment.
Endpoints
Primary:
o Any new late toxicity grade >=3 according to CTC AE 5.0
Secondary
Derived projects
Enrollment
Sex
Ages
Volunteers
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 plan≥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
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
Primary purpose
Allocation
Interventional model
Masking
20 participants in 1 patient group
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Central trial contact
Jesper Eriksen, Professor; Kenneth Jensen, PhD
Data sourced from clinicaltrials.gov
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