In the first place, we will collect tissues from over-reacting patients, including a thorough quality assurance program. Thereafter, we will identify the gene profiles of the patients that exhibit extreme radio-sensitivity without known hereditary…
ID
Source
Brief title
Condition
- Miscellaneous and site unspecified neoplasms benign
Synonym
Research involving
Sponsors and support
Intervention
Outcome measures
Primary outcome
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.
Secondary outcome
not applicable
Background summary
Radiotherapy is an important treatment modality for many cancers. The doses
that are used in patients are to a great extend based on the clinical
experience that was derived from historical series. However, in most cases,
there was great uncertainty about the doses and the volumes that normal tissues
had received. This is at present, with the advent of modern 3D and 4D
technology no longer the case.
However, on top of the historical dosimetric uncertainties involved, the
so-called normal tissue tolerance was derived from the most radiosensitive
sub-group of patients. As the incidence of severe, late irreversible tissue
damage could not exceed 5 %, the 5 % most radiosensitive patients thus
determined the prescribed radiation doses. However, because of this, radiation
dose-escalation and therefore a higher chance of local tumor control is
hampered. Identifying the most radiosensitive group would therefore have huge
clinical implications. This is the aim of the present investigation.
Identification of the most susceptible patients for severe radiation damage
before the onset of the treatment would allow reducing side effects in this
group by reducing the radiation dose (if the premise holds that their tumors
are indeed also extremely radio-sensitive) or by offering them alternative
treatments if available, whilst the majority of the other patients could
benefit with more aggressive therapies such as dose-escalation.
Study objective
In the first place, we will collect tissues from over-reacting patients,
including a thorough quality assurance program. Thereafter, we will identify
the gene profiles of the patients that exhibit extreme radio-sensitivity
without known hereditary hyper-radio-sensitivity syndromes.
Study design
20 patients, each overreacting to radiotherapy, 24 ml of blood will be taken
and an skin biopsy will be performed. This blood and tissue will be examined to
determine a relation between the overreaction to the radiotherapy and the
genetic material.
Study burden and risks
The burden for the participating patient only includes a single blood drawing
and a skin biopsy of the upper arm at a time when the patient is already
present for treatment or follow-up.
Patients don't need an extra visit to MAASTRO clinic.
The risks are the common risks involved with drawin blood or a skin biopsy.
Dr. Tanslaan 12
6229 ET Maastricht
Nederland
Dr. Tanslaan 12
6229 ET Maastricht
Nederland
Listed location countries
Age
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
Design
Recruitment
Followed up by the following (possibly more current) registration
No registrations found.
Other (possibly less up-to-date) registrations in this register
No registrations found.
In other registers
| Register | ID |
|---|---|
| CCMO | NL18062.068.07 |