CI

At a glance

ClinicalIndex Comparison Record
Phase 2Completed· 261 enrolled
Drug / intervention
Cediranib Maleate +5 moredrug
Likely dose
Not stated in record
Structured eligibility isn't available for this trial yet — see the full criteria in the Eligibility tab below.

Standardized by ClinicalIndex from the ClinicalTrials.gov record · verify against the source.

Search/NCT01062425
NCT01062425Phase 2Completed

Randomized, Phase II, Double-Blind, Placebo-Controlled Trial of Conventional Chemoradiation and Adjuvant Temozolomide Plus Cediranib Versus Conventional Chemoradiation and Adjuvant Temozolomide Plus Placebo in Patients With Newly Diagnosed Glioblastoma

National Cancer Institute (NCI)·interventional·Posted Feb 4, 2010·Updated Jul 26, 2022

In Brief

A Phase 2 clinical trial evaluating 3-Dimensional Conformal Radiation Therapy, Cediranib Maleate, and 4 other interventions for Adult Glioblastoma and Adult Gliosarcoma. Completed, enrolled 261 participants across 105 sites.

Detailed Summary

This randomized phase II trial studies temozolomide, radiation therapy, and cediranib maleate to see how well they work compared with temozolomide, radiation therapy, and a placebo in treating patients with newly diagnosed glioblastoma (a type of brain tumor). Drugs used in chemotherapy, such as temozolomide, work in different ways to stop the growth of tumor cells, either by killing the cells or by stopping them from dividing. Radiation therapy uses high energy x-rays to kill tumor cells. Cediranib maleate may stop the growth of tumor cells by blocking some of the enzymes needed for cell growth and by blocking blood flow to the tumor. It is not yet known whether temozolomide and radiation therapy are more effective when given with or without cediranib maleate in treating glioblastoma.

Study Details

Study Typeinterventional
Allocation--
Masking--
Primary Purpose--
CountriesUnited States

Timeline

Phase 2CompletedFinished
20102011201220132014201520162017201820192020202120222023202420252026
First PostedFeb 4, 2010
Enrollment StartFeb 26, 2010
Primary CompletionDec 6, 2015
Study CompletionMay 20, 2022
TodayJul 2, 2026
Enrollment to primary: 5.8 yearsPosted 16.4 years ago

Interventions

3-Dimensional Conformal Radiation Therapyradiation

Undergo 3-dimensional conformal radiotherapy

Cediranib Maleatedrug

Given PO

Intensity-Modulated Radiation Therapyradiation

Undergo intensity-modulated radiation therapy

Laboratory Biomarker Analysisother

Correlative studies

Placebo Administrationother

Given PO

Temozolomidedrug

Given PO