Radiation Therapy With or Without Temozolomide in Treating Older Patients With Newly Diagnosed Glioblastoma Multiforme
This study is currently recruiting participants.
Verified April 2013 by NCIC Clinical Trials Group
Sponsor:
NCIC Clinical Trials Group
Collaborators:
European Organisation for Research and Treatment of Cancer - EORTC
Trans-Tasman Radiation Oncology Group (TROG)
Information provided by (Responsible Party):
NCIC Clinical Trials Group
ClinicalTrials.gov Identifier:
NCT00482677
First received: June 4, 2007
Last updated: April 19, 2013
Last verified: April 2013
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Purpose
RATIONALE: Radiation therapy uses high-energy x-rays to kill tumor cells. 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. Giving radiation therapy together with temozolomide may kill more tumor cells. It is not yet known whether radiation therapy and temozolomide are more effective than radiation therapy alone in treating glioblastoma multiforme.
PURPOSE: This randomized phase III trial is studying radiation therapy and temozolomide to see how well they work compared with radiation therapy alone in treating patients with newly diagnosed glioblastoma multiforme.
| Condition | Intervention | Phase |
|---|---|---|
|
Brain and Central Nervous System Tumors |
Drug: temozolomide Genetic: DNA methylation analysis Procedure: quality-of-life assessment Radiation: Radiation |
Phase 3 |
| Study Type: | Interventional |
| Study Design: | Allocation: Randomized Endpoint Classification: Safety/Efficacy Study Intervention Model: Parallel Assignment Masking: Open Label Primary Purpose: Treatment |
| Official Title: | A Randomized Phase III Study of Temozolomide and Short-Course Radiation Versus Short-Course Radiation Alone In The Treatment of Newly Diagnosed Glioblastoma Multiforme in Elderly Patients |
Resource links provided by NLM:
Further study details as provided by NCIC Clinical Trials Group:
Primary Outcome Measures:
- Overall survival [ Time Frame: 7 years ] [ Designated as safety issue: No ]
Secondary Outcome Measures:
- Progression-free survival [ Time Frame: 7 years ] [ Designated as safety issue: No ]
- Adverse events [ Time Frame: 7 years ] [ Designated as safety issue: Yes ]
- Quality of life [ Time Frame: 7 years ] [ Designated as safety issue: No ]
- Methylation status of the O6-methylguanine-DNA methyltransferase promoter [ Time Frame: 7 years ] [ Designated as safety issue: No ]
| Estimated Enrollment: | 560 |
| Study Start Date: | May 2007 |
| Estimated Study Completion Date: | July 2015 |
| Estimated Primary Completion Date: | July 2014 (Final data collection date for primary outcome measure) |
| Arms | Assigned Interventions |
|---|---|
|
Active Comparator: Temozolomide
Temozolomide and short course radiation
|
Drug: temozolomide
Temozolomide (concurrent with radiation) 75 mg/m2 PO 3 weeks once a day, daily, from the first day to the last day of radiotherapy, but for no longer than 28 days
Genetic: DNA methylation analysis
A stratified log-rank test, adjusting for the stratification factors (except centre) plus MGMT promoter methylation status, will be used as the primary method to compare the overall survival between the two arms
Procedure: quality-of-life assessment
prior to randomization until end of study
|
|
Active Comparator: Radiation
Short course radiation alone
|
Genetic: DNA methylation analysis
A stratified log-rank test, adjusting for the stratification factors (except centre) plus MGMT promoter methylation status, will be used as the primary method to compare the overall survival between the two arms
Procedure: quality-of-life assessment
prior to randomization until end of study
Radiation: Radiation
Short course radiotherapy
|
Detailed Description:
OBJECTIVES:
Primary
- Compare overall survival rates in older patients with newly diagnosed glioblastoma multiforme treated with short-course radiotherapy with or without temozolomide.
Secondary
- Compare progression-free survival of patients treated with these regimens.
- Compare the nature, severity, and frequency of adverse events in patients treated with these regimens.
- Compare the quality of life of patient treated with these regimens.
- Determine the methylation status of the O6-methylguanine-DNA methyltransferase promoter.
OUTLINE: This is a multicenter, randomized study. Patients are stratified according to center, age (65-70 years vs 71-75 years vs ≥ 76 years), ECOG performance status (0-1 vs 2), and extent of resection at surgery (biopsy only vs complete or incomplete resection). Patients are randomized to 1 of 2 treatment arms.
- Arm I: Patients undergo radiotherapy once daily on days 1-5, 8-12, and 15-19 in the absence of disease progression or unacceptable toxicity.
- Arm II: Patients undergo radiotherapy as in arm I and receive oral temozolomide once daily on days 1-21.
Beginning 4 weeks after completion of radiotherapy and temozolomide, patients receive adjuvant oral temozolomide once daily on days 1-5. Treatment with temozolomide alone repeats every 28 days for up to 12 months in the absence of disease progression or unacceptable toxicity.
Patients complete quality of life questionnaires at baseline and periodically during study treatment.
Tissue samples are collected at baseline and analyzed for methylation status of the O6-methylguanine-DNA methyltransferase promoter.
After completion of study treatment, patients are followed every 3 months.
Eligibility| Ages Eligible for Study: | 65 Years and older |
| Genders Eligible for Study: | Both |
| Accepts Healthy Volunteers: | No |
Criteria
DISEASE CHARACTERISTICS:
Histopathologically confirmed glioblastoma multiforme
- Grade IV disease by WHO classification
- Newly diagnosed disease
- Initial diagnostic surgery or biopsy performed within the past 4 weeks
- Not a candidate for standard radiotherapy (60Gy/30 fractions over 6 weeks) in combination with temozolomide
PATIENT CHARACTERISTICS:
- ECOG performance status 0-2
- Absolute granulocyte count ≥ 1,500/mm³
- Platelet count ≥ 100,000/mm³
- Creatinine ≤ 1.5 times upper limit of normal (ULN)
- Bilirubin ≤ 1.5 times ULN
- ALT and AST < 2.5 times ULN
- No known hypersensitivity to temozolomide or compounds with similar chemical composition to temozolomide
- No history of other malignancies except adequately treated nonmelanoma skin cancer, curatively treated in situ cancer of the cervix, or other curatively treated solid tumors with no evidence of disease for at least 5 years
- No serious active infection (e.g., wound infection requiring parenteral antibiotics) or other serious underlying medical conditions that would preclude study treatment
- No other condition (e.g., psychological or geographical) that would preclude study compliance
PRIOR CONCURRENT THERAPY:
- No prior chemotherapy
- No prior radiotherapy
- No prior or concurrent investigational therapy
- No concurrent surgical procedures for tumor debulking
- No concurrent stereotactic boost radiotherapy
- No other concurrent chemotherapy, immunotherapy, or biological therapy
- No concurrent epoetin alfa
- Concurrent corticosteroids allowed provided the patient has been on a stable or decreasing dose for at least 14 days
Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT00482677
Contacts
| Contact: Chris O'Callaghan | 613-533-6430 | cocallaghan@ctg.queensu.ca |
Locations
| Canada, Alberta | |
| Tom Baker Cancer Centre | Recruiting |
| Calgary, Alberta, Canada, T2N 4N2 | |
| Contact: Jacob Easaw 403 521-3446 | |
| Cross Cancer Institute | Withdrawn |
| Edmonton, Alberta, Canada, T6G 1Z2 | |
| Canada, British Columbia | |
| BCCA - Fraser Valley Cancer Centre | Not yet recruiting |
| Surrey, British Columbia, Canada, V3V 1Z2 | |
| Contact: Alexander L. Agranovich 604 930-4036 | |
| BCCA - Vancouver Cancer Centre | Recruiting |
| Vancouver, British Columbia, Canada, V5Z 4E6 | |
| Contact: Michael McKenzie 604 877-6000 ext 2380 | |
| BCCA - Vancouver Island Cancer Centre | Recruiting |
| Victoria, British Columbia, Canada, V8R 6V5 | |
| Contact: Howard H. Pai 250 519-5576 | |
| Canada, Manitoba | |
| CancerCare Manitoba | Recruiting |
| Winnipeg, Manitoba, Canada, R3E 0V9 | |
| Contact: Marshall W. Pitz 204 787-8642 | |
| Canada, New Brunswick | |
| Atlantic Health Sciences Corporation | Recruiting |
| Saint John, New Brunswick, Canada, E2L 4L2 | |
| Contact: Farah Naz 506 648-6884 | |
| Canada, Nova Scotia | |
| QEII Health Sciences Centre | Recruiting |
| Halifax, Nova Scotia, Canada, B3H 1V7 | |
| Contact: Liam A. Mulroy 902 473-6096 | |
| Canada, Ontario | |
| Juravinski Cancer Centre at Hamilton Health Sciences | Recruiting |
| Hamilton, Ontario, Canada, L8V 5C2 | |
| Contact: Hal Hirte 905 387-9495 | |
| London Regional Cancer Program | Recruiting |
| London, Ontario, Canada, N6A 4L6 | |
| Contact: David R. MacDonald 519 685-8640 | |
| Univ. Health Network-Princess Margaret Hospital | Recruiting |
| Toronto, Ontario, Canada, M5G 2M9 | |
| Contact: Caroline Chung 416 946-4510 ext 6513 | |
| Odette Cancer Centre | Recruiting |
| Toronto, Ontario, Canada, M4N 3M5 | |
| Contact: Arjun Sahgal 416 480-4834 | |
| Canada, Quebec | |
| CHUM - Hopital Notre-Dame | Recruiting |
| Montreal, Quebec, Canada, H2L 4M1 | |
| Contact: Giuseppina Laura Masucci 514 890-8254 | |
| McGill University - Dept. Oncology | Recruiting |
| Montreal, Quebec, Canada, H2W 1S6 | |
| Contact: Petr Kavan 514 398-1444 | |
| CHUQ-Pavillon Hotel-Dieu de Quebec | Withdrawn |
| Quebec City, Quebec, Canada, G1R 2J6 | |
| Centre hospitalier universitaire de Sherbrooke | Recruiting |
| Sherbrooke, Quebec, Canada, J1H 5N4 | |
| Contact: David Mathieu 819 346-1110 ext 14887 | |
| Centre hospitalier regional de Trois-Rivieres | Recruiting |
| Trois-Rivieres, Quebec, Canada, G8Z 3R9 | |
| Contact: Francois Vincent 819 697-3333 ext 63094 | |
| Germany | |
| Klinikum Der J.W. Goethe Universitaet | Recruiting |
| Frankfurt, Germany, 60590 | |
| Contact: Joachim Steinbach | |
| Universitaetsklinikum Freiburg | Recruiting |
| Freiburg, Germany, 79106 | |
| Contact: Thomas Reithmeier | |
| Universitaetsklinikum Leipzig | Recruiting |
| Leipzig, Germany, 04103 | |
| Contact: Rolf-dieter Kortmann | |
| Universitaetsklinikum Tuebingen | Not yet recruiting |
| Tuebingen, Germany, 72076 | |
| Contact: Christian Braun | |
| Japan | |
| Hiroshima University Hospital | Recruiting |
| Hiroshima, Japan, 734-8551 | |
| Contact: Kazuhiko Sugiyama | |
Sponsors and Collaborators
NCIC Clinical Trials Group
European Organisation for Research and Treatment of Cancer - EORTC
Trans-Tasman Radiation Oncology Group (TROG)
Investigators
| Study Chair: | Normand Laperriere, MD, FRCPC | Princess Margaret Hospital, Canada |
| Study Chair: | James R. Perry, MD, FRCPC | Edmond Odette Cancer Centre at Sunnybrook |
| Study Chair: | Alba A. Brandes, MD | Ospedale Bellaria |
| Study Chair: | Johan Menten, MD, PhD | U.Z. Gasthuisberg |
More Information
Additional Information:
No publications provided
| Responsible Party: | NCIC Clinical Trials Group |
| ClinicalTrials.gov Identifier: | NCT00482677 History of Changes |
| Obsolete Identifiers: | NCT00493207 |
| Other Study ID Numbers: | CE6, CAN-NCIC-CE6, EORTC-26062-22061, TROG 08.02, SPRI-CAN-NCIC-CE.6, CDR0000547163 |
| Study First Received: | June 4, 2007 |
| Last Updated: | April 19, 2013 |
| Health Authority: | Canada: Ethics Review Committee |
Keywords provided by NCIC Clinical Trials Group:
|
adult glioblastoma adult giant cell glioblastoma adult gliosarcoma |
Additional relevant MeSH terms:
|
Glioblastoma Nervous System Neoplasms Central Nervous System Neoplasms Astrocytoma Glioma Neoplasms, Neuroepithelial Neuroectodermal Tumors Neoplasms, Germ Cell and Embryonal Neoplasms by Histologic Type Neoplasms Neoplasms, Glandular and Epithelial |
Neoplasms, Nerve Tissue Neoplasms by Site Nervous System Diseases Temozolomide Dacarbazine Antineoplastic Agents, Alkylating Alkylating Agents Molecular Mechanisms of Pharmacological Action Pharmacologic Actions Antineoplastic Agents Therapeutic Uses |
ClinicalTrials.gov processed this record on May 19, 2013