Establishing the criteria for over-reacting patients
The criteria to define over-reacting patients were established. Overreacting patients that will be included in the prospective study are those with 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 agent(s)) will thus be allowed.
Severe side effects were defined as follows:
Severe acute side effects
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.
Identification of new partners
In the official news letter of the ESTRO, an article was written on the study to be launched on over-reacting patients. Since then, several institutes from different European countries have responded positively. Moreover, the NCI from Canada will also join our study.
Protocols for over-reacting patients
Identification of Patients
Patient Informed Consent Form: (EN),(NL)
Case Report Form (CRF)
this page was last updated on 29 October 2008