Clinical trial · Interventional
Conventional Adjuvant Temozolomide With Dose Intensive Temozolomide in Patients With Newly Diagnosed Glioblastoma
NCT01364064CI-TRIAL-00021134completedPhase 3ClinicalTrials.gov clinicaltrialsProvenance
- Source
- ClinicalTrials.gov
- Retrieved
- Sep 8, 2026
- Layer
- normalized (units and labels harmonized; values unchanged)
- Run
- ING-CLINICALTRIALS-20260908-000001
Summary
Brief summary (as posted)
This is a Phase III Trial Comparing Conventional Adjuvant Temozolomide with Dose Intensive Temozolomide in Patients with Newly Diagnosed Glioblastoma.
Conditions
Conditions (1)
Free-text conditions as registered, with the CancerIndex entity they were reconciled to and the match type.
| Condition (as posted) | Mapped entity | Match | Confidence |
|---|---|---|---|
| Glioblastoma | Glioblastoma | CURATED_BROADER | 0.80 |
Interventions
Interventions (1)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| TMZ | Drug | Temozolomide | ALIAS |
Design
Arms and outcomes
Arms (2)
- type
- ACTIVE_COMPARATOR
- label
- Conventional adjuvant Temozolomide
- description
- TMZ d 1-5 of 28-d cycle 6 cycles
- interventionNames
- Drug: TMZ
- type
- EXPERIMENTAL
- label
- Dose intensive Temozolomide
- description
- TMZ d 1-21 of 28-d cycle 6 cycles
- interventionNames
- Drug: TMZ
Primary outcomes (1)
- measure
- safety and efficacy
- timeFrame
- 5 years
Eligibility
Eligibility (as posted)
- Sex
- All
Show eligibility criteria text
Inclusion Criteria: 1\. Karnofsky performance status of ≥ 60. 2. Age ≥ 18 years. 4. 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 4. 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 5. 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. 6\. For females of child-bearing potential, negative serum pregnancy test within 72 hours prior to starting temozolomide. 7\. Women of childbearing potential and male participants must practice adequate contraception. Exclusion Criteria: 1. 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). 2. Recurrent or multifocal malignant gliomas 3. Metastases detected below the tentorium or beyond the cranial vault. 4. Prior chemotherapy or radiosensitizers for cancers of the head and neck region; note that prior chemotherapy for a different cancer is allowable. Prior use of Gliadel wafers or any other intratumoral or intracavitary treatment are not permitted. 5. Prior radiotherapy to the head or neck (except for T1 glottic cancer), resulting in overlap of radiation fields. 6. 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.
References
Publications (0)
Data not yet available
No reference posted for this study.