To investigate if concomitant and adjuvant temozolomide chemotherapy improves survival in elderly patients that are managed with a short course of radiotherapy.
ID
Source
Brief title
Condition
- Nervous system neoplasms malignant and unspecified NEC
Synonym
Research involving
Sponsors and support
Intervention
Outcome measures
Primary outcome
overall survival
Secondary outcome
progression free survival, toxicity, quality of life
Background summary
Glioblastoma are the most frequent and the most aggressive primary brain tumors
in adults. The standard of care for adults with glioblastoma consists of
chemo-irradiation with temozolomide. It is unclear however if elderly patients
(over 65 years of age) also benefit of this combined chemo-irradiation (as
compared to treatment with radiotherapy only). In another study it has been
shown that in elderly patients a shortened series of radiotherapy with a
biologically equivalent dosage (40 Gy in 15 fractions) results in a similar
outcome compared to 60 Gy in 30 fractions. This approach reduces the treatment
time considerable. The question now is, whether the survival of elderly
patients that are treated with a short course of radiotherapy is improved if
this schedule is combined with temozolomide chemotherapy.
Study objective
To investigate if concomitant and adjuvant temozolomide chemotherapy improves
survival in elderly patients that are managed with a short course of
radiotherapy.
Study design
prospective randomized phase III study
Intervention
daily 75 mg/m2 temozolomide (oral) concomitantly during the entire period of
radiotherapy, followed by up to 12 cycles of adjuvant temozolomide at a dose
level of 150-200 mg/m2 daily given day 1- 5 every 4 weeks.
Study burden and risks
The risks for the patients consist mainly of myelosuppresion, which if severe
may cause severe leukopenia and thrombocytopenia. This may result in a bleeding
tendency and a vulnerability for infections. Other side effects of temozolomide
are usually mild and self limiting upon discontinuation. These more aspecific
side effects (eg, like fatigue) can occasionally be pronounced. Apart from that
is the participation to a study and all that comes with that potentially a
burden for the patient. In view of the severity of the disease and its grave
prognosis these risks appear however acceptable.
av E Mounier 83/ bte11
1200 Brussel 9999
BE
av E Mounier 83/ bte11
1200 Brussel 9999
BE
Listed location countries
Age
Inclusion criteria
- Histopathologically confirmed newly diagnosed glioblastoma multiforme (GBM, WHO grade IV).
- The histological diagnosis must have been made after biopsy or neurosurgical tumour resection.
- Initial surgery/biopsy at diagnosis performed < 4 weeks (28 days) prior to randomization.
- Patient*s age is > 65 years.
- Patient is not deemed suitable by the treating physician to receive the standard radiotherapy regimen
- (60Gy/30 fractions over 6 weeks) in combination with temozolomide.
- ECOG performance status of 0, 1 or 2
- Patient may have received and continue to receive corticosteroids, but s/he have to be on a stable or decreasing dose for at least 14 days prior to randomization.
- Patient has not received prior chemotherapy or radiotherapy.
- Adequate hematological, renal and hepatic functions within 14 days prior to randomization
- Patients must be accessible for treatment and follow-up
- Informed consent
Exclusion criteria
- Patients with a history of other malignancies, except: adequately treated non-melanoma skin cancer, curatively treated in-situ cancer of the cervix, or other solid tumours curatively treated with no evidence of disease for > 5 years.
- Patients with a serious active infection (such as a wound infection requiring parenteral antibiotics) at the time of randomization or other serious underlying medical conditions that would impair the ability of the patient to receive protocol treatment.
- Patients with any condition (e.g. psychological, geographical, etc.) that does not permit compliance with the protocol.
- Patients with known hypersensitivity to temozolomide or compounds with similar chemical composition to temozolomide.
- Patients who have had treatment with any investigational cancer drug prior to randomization.
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 | EUCTR2008-001949-26-NL |
| ClinicalTrials.gov | NCT00482677 |
| CCMO | NL25615.078.09 |