overreaction radiotherapy
Conditions
Interventions
None listed
Sponsors
MAASTRO clinic
Eligibility
Age
18 Years to 99 Years
Inclusion criteria
Inclusion criteria: --Overreacting patients: severe acute or late side effects after radiotherapy without concurrent chemotherapy or *biologicals* (e.g. interferon), *targeted drugs* (e.g. EGFR or VEGF inhibitors) or radio-protectors (e.g. amifostine). Neo-adjuvant or adjuvant systemic treatment (e.g. chemotherapy, targeted agents) is thus allowed, as long as they are not given concurrently with radiotherapy. *Severe acute side effects: . CTCAE 3.0 grade 2 or more occurring at very low radiation doses where these side effects are unexpected . CTCAE 3.0 grade 3-4 lasting more than 4 weeks after the end of radiotherapy and/ or requiring surgical intervention at any time. * Severe late side effects: .CTCAE 3.0 grade 3-4 occurring or persisting more than 90 days after the end of radiotherapy. -Knowledge of the dose distribution known, making it clear that the adverse reaction was not due to radiotherapy technique or overdose.;-Concomitant medications at the time of radiotherapy known. -No known hereditary syndromes that increase radio-sensitivity (see list "Exclusion criteria.*). -Medical conditions that may influence the response to radiation known (systemic lupus erythematosus, scleroderma, rheumatoid arthritis) -Neo- or adjuvant chemotherapy or other drugs known. -Concomitant co-morbidities known: diabetes mellitus, COPD, Crohn*s disease, colitis, *
Exclusion criteria
Exclusion criteria: - Concurrent radiotherapy with . Chemotherapy, . *Biologicals* (e.g. interferon), . *Targeted drugs* (e.g. EGFR or VEGF inhibitors) or . Radio-protectors (e.g. amifostine). - Thorough knowledge of the dose distribution at least in 2D not known, even after re-calculation. - Concomitant medications at the time of radiotherapy not known. - Known hereditary syndromes that increase radio-sensitivity such as (2,3,7-11) . Ataxia telangiectasia, . The Nijmegen Breakage Syndrome, . Fanconi*s anemia, . The Li Fraumeni syndrome, . Cockayne*s syndrome
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Establish a tissue bank containing skin fibroblasts, whole blood, lymphocytes, plasma and lymphblastoid cell lines from twenty clinically radiation hypersensitive patients. A control group of patients, namely those who do not exhibit abnormal reactions to radiotherapy, is already available from the ongoing GENEPI I study. | — |
Countries
Netherlands
Outcome results
None listed