* To explore the single fraction dose and volume that can be safely given in a preoperative setting additional to the standard treatment of postoperative surgery and (chemo)radiation. * To assess the tumor control and (re)growth between surgery and…
ID
Source
Brief title
Condition
- Nervous system neoplasms malignant and unspecified NEC
- Nervous system neoplasms malignant and unspecified NEC
Synonym
Research involving
Sponsors and support
Intervention
Outcome measures
Primary outcome
* maximum tolerated dose (MTD)
* maximum tolerated irradiated volume (MTIV)
Secondary outcome
* Registration of postoperative surgical complications.
* Progression free survival.
* Overall survival.
Background summary
The prognosis of GBM patients is poor despite extensive therapeutic efforts
with surgery, (chemo) radiation and adjuvant chemotherapy. Radiotherapy has
shown to contribute significantly to the survival of GBM patients although
doses above 60 Gy showed no further improvement. Gross total resection is a
favorable prognostic factor for survival but microscopic total resection can
never be achieved. Also, extensive surgery may lead to neurological deficits,
which can deteriorate not only prognosis but also quality of life. In addition,
wound factors released during and after surgery can provoke accelerated tumor
cell proliferation and migration. In particular for GBM patients a relation
between tumor regrowth between surgery and radiotherapy and prognosis has been
shown. With our study of upfront radiotherapy we want to hit the tumor cells
before surgery to reduce the proliferation and migration postoperatively. We
hypothesize that this method will prevent or delay the regrowth of remnant
tumor cells and will increase the effect of adjuvant (chemo)radiation in a safe
and feasible manner.
Study objective
* To explore the single fraction dose and volume that can be safely given in a
preoperative setting additional to the standard treatment of postoperative
surgery and (chemo)radiation.
* To assess the tumor control and (re)growth between surgery and post-operative
radiotherapy.
* To confirm usability of the MRI to select GBM patients for preoperative
single fraction radiotherapy
* To explore the effect of the tumor and therapy on the red and white blood
cells
* To assess if there are any differences between the tumor characteristics of
the irradiated part of tumor and the non-irradiated part of the tumor
Study design
Phase I/II study
Intervention
Single fraction preoperative radiotherapy.
Study burden and risks
Complications can occur during or as a result of the standard treatment. The
preoperative radiation may cause the operation or the standard radiotherapy
treatment to postpone due to edema complications after this radiation.
Other disadvantages
- the extra MRI scan and radiation will cost extra time
- Extra infusion for the MRI
- 2 tot 6 extra blood samples (5cc per sample)
- Starting dexamethasone if not already prescribed
- extra telephone consults
Plesmanlaan 121
AMSTERDAM 1066CX
NL
Plesmanlaan 121
AMSTERDAM 1066CX
NL
Listed location countries
Age
Inclusion criteria
* 18 years or older
* Newly diagnosed GBM (based on MRI imaging or biopsy)
* Ability to undergo standard treatment consisting of (chemo)radiation and surgery (i.e. KPS > 70, indication that more than 70% of the tumor can be removed)
* Neuro-oncology multidisciplinary team consensus to include the patient for the current study
* Signed written informed consent
Exclusion criteria
* Prior or second invasive malignancy, except non-melanoma skin cancer, completely resected cervical or prostate cancer (with PSA of less than or equal to 0.1 ng/ml)
* Suspicion of primary tumor on CT thorax/abdomen in case no biopsy is available
* Inability to secure a *coldspot* in the tumor (volume of 2 cc of the contrast enhancing tumor that should not receive irradiation dose, see Chapter 2 and 4)
* Inability to secure radiotherapy dose constraints for organs at risk for either the neoadjuvant stereotactic radiosurgery or adjuvant fractionated radiotherapy (see Chapter 2 and 4)
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 | NL63385.031.18 |