Identification of the genetic pathways involved in patients overreacting to radiotherapy

Completed

• Conditions: overreaction; radiotherapy; 10027656

• Registration Number: NL-OMON35606
• Lead Sponsor: MAASTRO clinic

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Last Update Posted: 18 June 2024

Recruitment & Eligibility

• Status: Completed
• Sex: Not specified
• Target Recruitment: 6

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

- 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

Study & Design

• Study Type: Observational invasive
• Study Design: Not specified