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Primary Chemotherapy With Temozolomide Versus Radiotherapy in Patients With Low Grade Gliomas After Stratification for Genetic 1p Loss: A Phase III Study

Phase 3
18 Years
Open (Enrolling)
Brain and Central Nervous System Tumors

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Trial Information

Primary Chemotherapy With Temozolomide Versus Radiotherapy in Patients With Low Grade Gliomas After Stratification for Genetic 1p Loss: A Phase III Study



- 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.

Inclusion Criteria


- Histologically confirmed low-grade glioma, including any of the following types:

- Astrocytoma (gemistocytic, fibrillary, or protoplasmatic)

- Oligoastrocytoma

- Oligodendroglioma

- 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

Performance status

- WHO 0-2

Life expectancy

- 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)


Biologic 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

Endocrine therapy

- 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

- Occasional use of nonsteroidal anti-inflammatory drugs for pain allowed

Type of Study:


Study Design:

Allocation: Randomized, Masking: Open Label, Primary Purpose: Treatment

Outcome Measure:

Progression-free survival

Outcome Time Frame:

5 years

Safety Issue:


Principal Investigator

Brigitta Baumert, MD, PhD

Investigator Role:

Study Chair

Investigator Affiliation:

Maastricht University Medical Center


Canada: Health Canada

Study ID:




Start Date:

July 2005

Completion Date:

Related Keywords:

  • Brain and Central Nervous System Tumors
  • adult oligodendroglioma
  • adult diffuse astrocytoma
  • adult mixed glioma
  • Glioma
  • Nervous System Neoplasms
  • Central Nervous System Neoplasms