To determine the best treatment for anaplastich oligodendroglial tumors with combined 1p/19q loss, and to determine the optimal treatment with respect to the maintenance of a maximal neurological and cognitive functioning.
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
Overall survival, primary question: does the addition of temozolomide
chemotherapy to radiotherapy increase overall survival?
Secondary outcome
Time to event which is defined as the time from study registration to the
earliest evidence of 1) clinical progression, 2) radiographic progression, or
3) neurocognitive progression, whichever comes first
Background summary
The best treatment for anaplastic oligodendroglial tumors is present unclear.
Previous studies have shown that these patients have a median survival of more
than 7 years, and that these tumors respond favorably to both radiation
therapy and chemotherapy. However, these studies failed to provide evident that
chemotherapy given immediately after radiotherapy improves survival (although
it was shown that adjuvant chemotherapy does improve progression free
survival, but it remained unclear if that translates in a longer good clinical
condition). Another study has observed an improved outcome in glioblastoma if
radiotherapy is combined with temozolomide chemotherapy, it is however unclear
if the addition of temozolomide to radiotherapy increases delayed
neurotoxicities. Because of the prolonged survival of 1p/19q co-deleted
anaplastic oligodendroglioma these patients are longer at risk to develop
radiotherapy associated delayed neurotoxicities. Because of these
considerations, at present there is no agreement how these patients should be
treated. The present study is designed to resolve this issue. Because of the
potential of increased neurotoxicities if the initial treatment intensity is
intensified, quality of life studies and evaluation of cognitive functioning
are important secondary objectives.
Study objective
To determine the best treatment for anaplastich oligodendroglial tumors with
combined 1p/19q loss, and to determine the optimal treatment with respect to
the maintenance of a maximal neurological and cognitive functioning.
Study design
Three armed randomized phase III study.
Intervention
either 59.4 Gy radiotherapy in 33 fractions, the same radiotehrapy regimen in
combination with concurrent and adjuvant temozolomide chemotherapy, or one year
standard temozolomide chemotherapy
Study burden and risks
The treatments given within this study are standard of care for this patient
population, and apart from the known risk and side effects do not impose
further hazards. In addition to that, there are the known burdens of the
participation to a study, like the filling in of quality of life questionnaires
and the repeated neuropsychological evaluations.
Av E Mounier 83/11
Brussel 1200
BE
Av E Mounier 83/11
Brussel 1200
BE
Listed location countries
Age
Inclusion criteria
* Provide informed written consent.
* Patient willing to provide tissue samples for deletion status
* *18 years of age.
* Newly diagnosed and <3 months from surgical diagnosis.
* Histological confirmation of anaplastic oligodendroglioma or mixed anaplastic oligoastrocytoma (grade 3-4)
* Loss of heterozygosity for both 1p and 19q (*co-deletion*).
* *2 weeks from the date of surgery and must have recovered from the effects of surgery
* Adequate hematological, renal and liver function
* Negative pregnancy test (B-HCG) done *7 days prior to registration, for women of childbearing potential only.
* Willing and able to complete neurocognitive/QOL questionnaire(s) by themselves or with assistance
* ECOG performance status (PS) of 0 1 or 2
Exclusion criteria
* For women: not pregnant or nursing, for all patients of childbearing potential: willing to employ adequate contraception
* No prior surgery, radiotherapy or chemotherapy for any CNS neoplasm
* No co-morbid systemic illnesses or other severe concurrent disease which, would interfere significantly with the proper assessment of safety and toxicity of the prescribed regimens.
* No concomitant serious immuno-compromised status (other than that related to concomitant steroids).
* No active uncontrolled systemic infection or HIV.
* Not receiving any other investigational agent which would be considered as a treatment for the primary neoplasm.
* No active other malignancy, excepting non-melanotic skin cancer or carcinoma-in-situ of the cervix. If there is a history of prior malignancy, they must not be receiving other specific treatment (other than hormonal therapy) for their cancer.
* No history of myocardial infarction *6 months, or congestive heart failure requiring use of ongoing maintenance therapy for life-threatening ventricular arrhythmias.
Design
Recruitment
Medical products/devices used
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 |
|---|---|
| EudraCT | EUCTR2008-007295-14-NL |
| ClinicalTrials.gov | NCT00887146 |
| CCMO | NL31202.078.10 |