NL-OMON35606
Completed
Not Applicable
Identification of the genetic pathways involved in patients overreacting to radiotherapy - GENEPI II
Overview
- Phase
- Not Applicable
- Intervention
- Not specified
- Conditions
- Not specified
- Sponsor
- MAASTRO clinic
- Enrollment
- 6
- Status
- Completed
- Last Updated
- last year
Overview
Brief Summary
No summary available.
Investigators
Eligibility 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)
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,
Outcomes
Primary Outcomes
Not specified
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