Radiation Therapy or Temozolomide in Treating Patients With Gliomas
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|ClinicalTrials.gov Identifier: NCT00182819|
Recruitment Status : Completed
First Posted : September 16, 2005
Last Update Posted : October 12, 2016
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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. It is not yet known whether radiation therapy is more effective than temozolomide in treating gliomas.
PURPOSE: This randomized phase III trial is studying radiation therapy to see how well it works compared to temozolomide in treating patients with gliomas.
|Condition or disease||Intervention/treatment||Phase|
|Brain and Central Nervous System Tumors||Drug: temozolomide Radiation: radiation therapy||Phase 3|
- Compare the progression-free survival of patients with low-grade gliomas treated with radiotherapy vs temozolomide.
- Compare the overall survival of patients treated with these regimens.
- Determine whether the incidence of late toxicity can be decreased in patients who are randomized to receive temozolomide.
- Compare the toxic effects of these regimens in these patients.
- Compare the quality of life of patients treated with these regimens.
OUTLINE: This is a randomized, controlled, multicenter study. Patients are stratified according to participating center, chromosome 1p status (deleted vs normal vs undeterminable), contrast enhancement on MRI (yes vs no), age (< 40 years vs ≥ 40 years), and WHO performance status (0 or 1 vs 2). Patients are randomized to 1 of 2 treatment arms.
- Arm I: Patients undergo radiotherapy once daily, 5 days a week, for a total of 28 fractions (i.e., 5½ weeks).
- Arm II: Patients receive oral temozolomide once daily on days 1-21. Treatment repeats every 28 days for up to 12 courses in the absence of disease progression or unacceptable toxicity.
Quality of life is assessed at baseline and then every 3 months until disease progression.
After completion of study treatment, patients are followed every 6 months for survival.
Peer Reviewed and Funded or Endorsed by Cancer Research UK
PROJECTED ACCRUAL: A minimum of 699 patients (a total of 466 randomized [233 per treatment arm]) will be accrued for this study within 5 years.
|Study Type :||Interventional (Clinical Trial)|
|Actual Enrollment :||709 participants|
|Masking:||None (Open Label)|
|Official Title:||Primary Chemotherapy With Temozolomide Versus Radiotherapy in Patients With Low Grade Gliomas After Stratification for Genetic 1p Loss: A Phase III Study|
|Study Start Date :||July 2005|
|Actual Primary Completion Date :||August 2013|
|Actual Study Completion Date :||May 2014|
Radiotherapy (control arm), 50.4 Gy, standard fractionation (28 x 1.8 Gy), conformal techniques
Radiation: radiation therapy
50.4 Gy, standard fractionation (28 x 1.8 Gy), conformal techniques
Temozolomide 75 mg/m2 daily x 21 days, q 28 days until progression or for max. 12 cycles (experimental arm)
Temozolomide 75 mg/m2 daily x 21 days, q 28 days until progression or for max. 12 cycles
- Progression-free survival [ Time Frame: 5 years ]
- Overall survival [ Time Frame: 5 years ]
- Quality of life as measured by QLQ-C30 v3.0 and EORTC BN-20 [ Time Frame: every 3 months until progression, and then every 6 months until death ]
- Mini-Mental State Examination [ Time Frame: every 3 months until progression, and then every 6 months until death ]
- Adverse events as measured by CTCAE v3.0 [ Time Frame: As indicated in the protocol ]
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|Ages Eligible for Study:||18 Years and older (Adult, Older Adult)|
|Sexes Eligible for Study:||All|
|Accepts Healthy Volunteers:||No|
Histologically confirmed low-grade glioma, including any of the following types:
- Astrocytoma (gemistocytic, fibrillary, or protoplasmatic)
- WHO grade II disease
- Supratentorial tumor location only
- RTOG neurological function 0-3
- Not a candidate for surgical treatment alone
Requires treatment, as determined by ≥ 1 of the following criteria:
- Age ≥ 40 years
- Radiologically-proven progressive lesion
- New or worsening neurological symptoms other than seizures only (e.g., focal deficits, signs of increased intracranial pressure, or mental deficits)
Intractable seizures, defined by both of the following criteria:
- Experiences persistent seizures that interfere with everyday life activities except driving a car
- Failed 3 anti-epileptic drug regimens, including ≥ 1 combination regimen
- Tumor material (paraffin-embedded) or histopathologic slides available
- 18 and over
- WHO 0-2
- Not specified
- Absolute neutrophil count ≥ 1,500/mm^3
- Platelet count ≥ 100,000/mm^3
- No chronic hepatitis B or C infection
- Bilirubin ≤ 1.5 times upper limit of normal (ULN)
- AST or ALT ≤ 2.5 times ULN
- Alkaline phosphatase ≤ 2.5 times ULN
- Creatinine ≤ 1.5 times ULN
- Not pregnant or nursing
- Fertile patients must use effective contraception during and for 6 months after completion of study treatment
- No known HIV positivity
- No other serious medical condition
- No other prior or concurrent malignancy except surgically cured carcinoma in situ of the cervix or nonmelanoma skin cancer
- No psychological, familial, sociological, or geographical condition that would preclude study participation
- No medical condition that would preclude receiving oral medication (e.g., frequent vomiting or partial bowel obstruction)
PRIOR CONCURRENT THERAPY:
- No concurrent growth factors for elevating absolute neutrophil counts for the purpose of temozolomide administration
- No concurrent epoetin alfa
- No concurrent immunotherapy or biologic therapy
- No prior chemotherapy
- No other concurrent chemotherapy, including adjuvant chemotherapy for patients randomized to undergo radiotherapy
- Not specified
- No prior radiotherapy to the brain
- No concurrent integrated boost with intensity-modulated radiotherapy
- Recovered from prior surgery
- No concurrent surgical tumor debulking
- No prior randomization to this study
- No other concurrent investigational drugs
No concurrent regular use of agents known to be radiosensitizers or radioprotectors (e.g., cyclooxygenase-2 inhibitors, thalidomide, or amifostine) during study radiotherapy
- Occasional use of nonsteroidal anti-inflammatory drugs for pain allowed
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 ClinicalTrials.gov identifier (NCT number): NCT00182819
|Study Chair:||Brigitta Baumert, MD, PhD||Maastricht University Medical Center|
|Study Chair:||Roger Stupp, MD||Centre Hospitalier Universitaire Vaudois|
Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
|Responsible Party:||European Organisation for Research and Treatment of Cancer - EORTC|
|Other Study ID Numbers:||
2004-002714-11 ( EudraCT Number )
|First Posted:||September 16, 2005 Key Record Dates|
|Last Update Posted:||October 12, 2016|
|Last Verified:||October 2016|
adult diffuse astrocytoma
adult mixed glioma
Nervous System Neoplasms
Central Nervous System Neoplasms
Neoplasms, Germ Cell and Embryonal
Neoplasms by Histologic Type
Neoplasms, Glandular and Epithelial
Neoplasms, Nerve Tissue
Neoplasms by Site
Nervous System Diseases
Antineoplastic Agents, Alkylating
Molecular Mechanisms of Pharmacological Action