EUCTR2005-005177-29-LV进行中（未招募）不适用
Phase III trial comparing conventional adjuvant temozolomide with dose-intensive temozolomide in patients with newly diagnosed glioblastoma - RTOG
试验速览
- 阶段
- 不适用
- 状态
- 进行中（未招募）
- 发起方
- EORTC
- 入组人数
- 834
研究概览
简要总结
暂无简介。
研究设计
- 研究类型
- Interventional clinical trial of medicinal product
入排标准
- 性别
- All
入选标准
- •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
排除标准
- •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.
研究者
相似试验
进行中（未招募）
1 期
Phase III trial comparing conventional adjuvant temozolomide with dose-intensive temozolomide in patients with newly diagnosed glioblastoma - RTOGEUCTR2005-005177-29-BEEORTC1,125
进行中（未招募）
不适用
Phase III trial comparing conventional adjuvant temozolomide with dose-intensive temozolomide in patients with newly diagnosed glioblastoma - RTOGPatients with Glioblastoma MultiformeMedDRA version: 8.1Level: LLTClassification code 10018337Term: Glioblastoma multiformeEUCTR2005-005177-29-DEEORTC1,153
进行中（未招募）
不适用
Phase III trial comparing conventional adjuvant temozolomide with dose-intensive temozolomide in patients with newly diagnosed glioblastoma - RTOGEUCTR2005-005177-29-SIEORTC834
进行中（未招募）
不适用
Phase III trial comparing conventional adjuvant temozolomide with dose-intensive temozolomide in patients with newly diagnosed glioblastoma - RTOGEUCTR2005-005177-29-NLEORTC1,153
进行中（未招募）
1 期
Phase III trial comparing conventional adjuvant temozolomide with dose-intensive temozolomide in patients with newly diagnosed glioblastoma - RTOGEUCTR2005-005177-29-GBEORTC1,153