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Radiation Therapy, Temozolomide, and Irinotecan in Treating Patients With Newly Diagnosed Glioblastoma Multiforme

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details. Identifier: NCT00099125
Recruitment Status : Completed
First Posted : December 9, 2004
Last Update Posted : January 24, 2014
National Cancer Institute (NCI)
Information provided by (Responsible Party):
Radiation Therapy Oncology Group

Brief Summary:

RATIONALE: Radiation therapy uses high-energy x-rays to damage tumor cells. Drugs used in chemotherapy, such as temozolomide and irinotecan, work in different ways to stop tumor cells from dividing so they stop growing or die. Combining radiation therapy with chemotherapy may kill more tumor cells.

PURPOSE: This phase II trial is studying how well radiation therapy, temozolomide, and irinotecan work in treating patients with newly diagnosed glioblastoma multiforme.

Condition or disease Intervention/treatment Phase
Brain and Central Nervous System Tumors Drug: irinotecan hydrochloride Drug: temozolomide Procedure: adjuvant therapy Radiation: radiation therapy Phase 2

Detailed Description:


  • Compare overall survival of patients with newly diagnosed supratentorial glioblastoma multiforme treated with radiotherapy and temozolomide followed by temozolomide and irinotecan with historical controls from the RTOG database.
  • Determine the short- and long-term toxicity of this regimen in these patients.
  • Determine progression-free survival of patients treated with this regimen.

OUTLINE: This is a multicenter study.

  • Chemoradiotherapy: Patients undergo radiotherapy once daily, 5 days a week, for 6 weeks. Concurrently with radiotherapy, patients receive oral temozolomide once daily, 7 days a week, for 6 weeks.
  • Post-radiotherapy chemotherapy: Beginning 4-6 weeks after the completion of chemoradiotherapy, patients receive irinotecan IV on days 1 and 15 and oral temozolomide once daily on days 1-5. Treatment repeats every 28 days for up to 1 year in the absence of disease progression or unacceptable toxicity.

Patients are followed every 2 months for 2 years and then every 6 months thereafter.

PROJECTED ACCRUAL: A total of 157 patients will be accrued for this study within 11 months.

Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 170 participants
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: A Phase II Study Of Radiation Therapy Plus Low Dose Temozolomide Followed By Temozolomide Plus Irinotecan For Glioblastoma Multiforme
Study Start Date : November 2004
Primary Completion Date : October 2006
Study Completion Date : November 2013

Arm Intervention/treatment
Experimental: RT with chemotherapy + post-radiation chemotherapy
Radiation therapy (RT) with concurrent chemotherapy + post-radiation chemotherapy
Drug: irinotecan hydrochloride Drug: temozolomide Procedure: adjuvant therapy Radiation: radiation therapy

Primary Outcome Measures :
  1. Overall survival [ Time Frame: From registration to date of death or last follow-up. Analysis occurs after all patients have been potentially followed for 18 months. ]

Secondary Outcome Measures :
  1. Progression-free survival [ Time Frame: From randomization to date of progression, death, or last follow-up. Analysis occurs at the same time as the primary outcome analysis. ]

Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years and older   (Adult, Senior)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No


  • Histologically confirmed newly diagnosed supratentorial glioblastoma multiforme by surgical biopsy or excision

    • No gliomas graded less than glioblastoma multiforme
    • No recurrent malignant gliomas
  • No tumor foci below the tentorium or beyond the cranial vault
  • Study therapy must begin ≤ 5 weeks after surgery



  • 18 and over

Performance status

  • Zubrod 0-1

Life expectancy

  • At least 8 weeks


  • Absolute neutrophil count ≥ 1,500/mm^3
  • Platelet count ≥ 100,000/mm^3
  • Hemoglobin ≥ 10 g/dL*
  • Hematocrit ≥ 30%* NOTE: *Transfusion allowed


  • Bilirubin ≤ 0.5 mg/dL
  • ALT or AST ≤ 2 times upper limit of normal


  • Creatinine ≤ 1.5 mg/dL
  • BUN ≤ 25 mg/dL


  • Not pregnant or nursing
  • Negative pregnancy test
  • Fertile patients must use effective double-barrier contraception during and for 2 months after study participation
  • No AIDS
  • No other malignancy within the past 5 years except nonmelanoma skin cancer or carcinoma in situ of the cervix or bladder
  • No other major medical illness or psychiatric impairment that would preclude study participation


Biologic therapy

  • No concurrent sargramostim (GM-CSF)


  • No other concurrent chemotherapy

Endocrine therapy

  • Concurrent steroid therapy allowed provided patient is on a stable or decreasing dose for at least 2 weeks before study entry


  • No prior radiotherapy to the head or neck resulting in overlap of radiotherapy fields

    • Prior radiotherapy for stage T1 glottic cancer allowed


  • See Disease Characteristics
  • Recovered from prior surgery


  • No enzyme-inducing antiepileptic drugs within 14 days before the initiation of irinotecan

    • Concurrent non-enzyme-inducing antiepileptic drugs allowed

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its identifier (NCT number): NCT00099125

  Show 118 Study Locations
Sponsors and Collaborators
Radiation Therapy Oncology Group
National Cancer Institute (NCI)
Study Chair: Frank S. Lieberman, MD University of Pittsburgh
Study Chair: Christina I. Tsien, MD University of Michigan Cancer Center

Publications of Results:
Lieberman FS, Tsien C, Berkey B, et al.: Phase II trial of concomitant low dose temozolomide with external beam radiation (EBRT) followed by 12 months of temozolomide and irinotecan for newly diagnosed glioblastoma (GBM): preliminary results of RTOG 04-20. [Abstract] J Clin Oncol 24 (Suppl 18): A-1510, 2006.

Responsible Party: Radiation Therapy Oncology Group Identifier: NCT00099125     History of Changes
Other Study ID Numbers: RTOG-0420
First Posted: December 9, 2004    Key Record Dates
Last Update Posted: January 24, 2014
Last Verified: January 2014

Keywords provided by Radiation Therapy Oncology Group:
adult giant cell glioblastoma
adult gliosarcoma
adult glioblastoma

Additional relevant MeSH terms:
Nervous System Neoplasms
Central Nervous System Neoplasms
Neoplasms, Neuroepithelial
Neuroectodermal Tumors
Neoplasms, Germ Cell and Embryonal
Neoplasms by Histologic Type
Neoplasms, Glandular and Epithelial
Neoplasms, Nerve Tissue
Neoplasms by Site
Nervous System Diseases
Antineoplastic Agents, Phytogenic
Antineoplastic Agents
Topoisomerase I Inhibitors
Topoisomerase Inhibitors
Enzyme Inhibitors
Molecular Mechanisms of Pharmacological Action
Antineoplastic Agents, Alkylating
Alkylating Agents