Phase III trial comparing conventional adjuvant temozolomide with dose-intensive temozolomide in patients with newly diagnosed glioblastoma - RTOG

• Conditions: Patient with Glioblastoma Multiforme; MedDRA version: 9.0Level: LLTClassification code 10018337

• Registration Number: EUCTR2005-005177-29-NL
• Lead Sponsor: EORTC

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Study Start: 2006-09-28
• Last Update Posted: 19 March 2012

Recruitment & Eligibility

• Status: ot Recruiting
• Sex: All
• Target Recruitment: 1153

Inclusion Criteria

Histopathologically proven diagnosis of glioblastoma multiforme.
Patients must have at least 1 block of tissue available for analysis of MGMT status; fresh frozen tumor tissue acquisition is encouraged.
Diagnosis must be made by surgical biopsy or excision.
The tumor must have supratentorial component.
Patients must have recovered from the effects of surgery, post-operative infection, and other complications before study registration.
A diagnostic contrast-enhanced MRI or CT scan (if MRI is not available) of the brain must be performed preoperatively and postoperatively prior to the initiation of radiotherapy, within 28 days prior to study registration. Preoperative and postoperative scans must be the same type. If CT scans were performed perioperatively, a CT and an MRI should be performed before randomization.
Patients diagnosed only by stereotactic biopsy do not require the postoperative scan. However, these patients will only be eligible once review of the tissue block determines that an adequate sample is available for molecular analysis.
Patients unable to undergo MR imaging because of non-compatible devices can be enrolled, provided pre- and post-operative contrast-enhanced CT scans are obtained and are of sufficient quality.
Therapy must begin = 5 weeks after surgery.
History/physical examination within 14 days prior to study registration.
Neurologic examination within 14 days prior to study registration.
Documentation of steroid doses within 14 days prior to study registration and stable or decreasing steroid dose within 5 days prior to registration.
Karnofsky performance status of = 60.
Age = 18 years.
CBC/differential obtained within 14 days prior to study registration, with adequate bone marrow function as defined below:
Absolute neutrophil count (ANC) = 1500 cells/mm3.
Platelets = 100,000 cells/mm3.
Hemoglobin = 10 g/dl. (Note: The use of transfusion or other intervention to achieve Hgb = 10 g/dl is acceptable.)
Adequate renal function, as defined below:
BUN = 25 mg/dl within 14 days prior to study registration
Creatinine = 1.7 mg/dl within 14 days prior to study registration
Adequate hepatic function, as defined below:
Bilirubin = 2.0 mg/dl within 14 days prior to study registration
ALT = 3 x normal range within 14 days prior to study registration
AST = 3 x normal range within 14 days prior to study registration
Patients must sign a study-specific informed consent prior to study registration. If the patient’s mental status precludes his/her giving informed consent, written informed consent may be given by the responsible family member.
For females of child-bearing potential, negative serum pregnancy test within 72 hours prior to starting temozolomide.
Women of childbearing potential and male participants must practice adequate contraception.

Are the trial subjects under 18? no
Number of subjects for this age range:
F.1.2 Adults (18-64 years) yes
F.1.2.1 Number of subjects for this age range
F.1.3 Elderly (>=65 years) yes
F.1.3.1 Number of subjects for this age range

Exclusion Criteria

Prior invasive malignancy (except for non-melanomatous skin cancer) unless disease free for = 3 years. (For example, carcinoma in situ of the breast, oral cavity, and cervix are all permissible).
Recurrent or multifocal malignant gliomas
Metastases detected below the tentorium or beyond the cranial vault.
Prior chemotherapy or radiosensitizers (including Gliadel wafers) for cancers of the head and neck region; note that prior chemotherapy for a different cancer is allowable.
Prior radiotherapy to the head or neck (except for T1 glottic cancer), resulting in overlap of radiation fields.
Severe, active co-morbidity, defined as follows:
Unstable angina and/or congestive heart failure requiring hospitalization
Transmural myocardial infarction within the last 6 months
Acute bacterial or fungal infection requiring intravenous antibiotics at the time of registration
Chronic Obstructive Pulmonary Disease exacerbation or other respiratory illness requiring hospitalization or precluding study therapy at the time of registration
Hepatic insufficiency resulting in clinical jaundice and/or coagulation defects; note, however, that laboratory tests for liver function and coagulation parameters are not required for entry into this protocol.
Acquired Immune Deficiency Syndrome (AIDS) based upon current CDC definition; note, however, that HIV testing is not required for entry into this protocol. The need to exclude patients with AIDS from this protocol is necessary because the treatments involved in this protocol may be significantly immunosuppressive.
Major medical illnesses or psychiatric impairments that in the investigator's opinion will prevent administration or completion of protocol therapy.
Active connective tissue disorders, such as lupus or scleroderma, that in the opinion of the treating physician may put the patient at high risk for radiation toxicity.
Pregnancy or women of childbearing potential and men who are sexually active and not willing/able to use medically acceptable forms of contraception; this exclusion is necessary because the treatment involved in this study may be significantly teratogenic.
Pregnant or lactating women, due to possible adverse effects on the developing fetus or infant due to study drug;
Prior allergic reaction to temozolomide.
Patients treated on any other therapeutic clinical protocols within 30 days prior to study entry or during participation in the study.
No tissue provided for histopathologic central review and MGMT status.

Study & Design

• Study Type: Interventional clinical trial of medicinal product
• Study Design: Not specified