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RTOG 0834   |   CC945
Phase III Trial on Concurrent and Adjuvant Temozolomide Chemotherapy in Non-1p/19q Deleted Anaplastic Glioma. The CATNON Intergroup Trial.

Disease(s)
Brain
Hospital(s)
Main Campus
Phase(s)
Phase 3
Stage(s)
N/A
Type(s)
Therapeutic
Drug(s)
Temozolomide (SCH 52365)

Contact Information
Cancer Answer Line

866.223.8100

8:00 am - 4:30 pm, Monday - Friday


Description

Primary objectives

  • To assess whether concurrent radiotherapy with daily temozolomide chemotherapy improves overall survival as compared to no daily temozolomide in patients with non-1p/19q deleted anaplastic glioma.
  • To assess whether adjuvant temozolomide chemotherapy improves survival as compared to no adjuvant temozolomide chemotherapy in patients with non-1p/19q deleted anaplastic glioma

Secondary objectives

  • To assess whether concurrent and adjuvant temozolomide treatment prolongs progression free survival and neurological deterioration free survival in patients with non-1p/19q deleted anaplastic glioma.
  • To assess the safety of concurrent and adjuvant temozolomide in patients with non-1p/19q deleted anaplastic glioma, including late effects on cognition.
  • To assess the impact of concurrent and adjuvant temozolomide treatment on the quality of life in patients with non-1p/19q deleted anaplastic glioma.

Endpoints

  1. Primary endpoint: The primary endpoint of the study is overall survival, as measured from the day of randomization.
  2. Secondary endpoints: Secondary endpoints of the study are progression free survival, neurological deterioration free survival, quality of life, toxicity, and development of cognitive deterioration.

Inclusion Criteria

At the time of registration:

  • Histologically confirmed newly diagnosed anaplastic oligodendroglioma, anaplastic oligoastrocytoma or anaplastic astrocytoma by local diagnosis
  • Availability of tumor material for central 1p/19q assessment, central MGMT promoter methylation assessment and central pathology review.
  • Previous surgery for a low grade tumor is allowed, provided histological confirmation of an anaplastic tumor is present at the time of progression
  • WHO performance status 0-2
  • Age ≥ 18 years
  • All patients must use effective contraception if of reproductive potential. Females must not be pregnant or breast feeding
  • Absence of known HIV infection, chronic hepatitis B or hepatitis C infection
  • Absence of any other serious medical condition that can interfere with follow-up
  • Absence of any medical condition which could interfere with oral medication intake (e.g., frequent vomiting, partial bowel obstruction)
  • Absence of previous or concurrent malignancies at other sites with the exception of surgically cured carcinoma in situ of the cervix and non-melanoma skin cancer.
  • Absence of any psychological, familial, sociological or geographical condition potentially hampering compliance with the study protocol and follow-up schedule; those conditions should be discussed with the patient before registration in the trial
  • No prior chemotherapy (including no treatment with BCNU containing wafers (Gliadel®)
  • No prior radiotherapy to the brain
  • Before patient registration, written informed consent must be obtained, according to ICH/GCP, and national/local regulations.

Randomization step:

  • The combination of :
    • Histologically confirmed newly diagnosed anaplastic oligodendroglioma, anaplastic oligoastrocytoma or anaplastic astrocytoma by local diagnosis
    • AND
    • Absence of combined 1p/19q loss
    both of which must have been determined by either local testing or central review
  • Availability of tumor material for central 1p/19q assessment, central MGMT promoter methylation assessment and central pathology review
  • WHO performance status 0-2
  • Age ≥ 18 years
  • Previous surgery for a low grade tumor is allowed, provided histological confirmation of an anaplastic tumor is present at the time of progression
  • Start of radiotherapy within 8 days from randomization
  • Start of radiotherapy within 7 weeks (49 days) from surgery
  • Patients must be on a stable or decreasing dose of steroids for at least two weeks
  • No prior chemotherapy (including no treatment with BCNU containing wafers (Gliadel®)
  • No prior radiotherapy to the brain
  • No concomitant treatment with other anti-cancer agents or with any other experimental agent
  • Adequate hematological, renal and hepatic function according to all of the following laboratory values (to be performed within 14 days prior to randomization):
    • neutrophils greater or equal to 1.5*109 cells/l
    • platelets greater or equal to 100*109 cells/l
    • bilirubin < 1.5 times upper limit of laboratory normal
    • alkaline phosphatase, ASAT and ALAT < 2.5 times upper limit of laboratory normal
    • serum creatinine lower than 1.5 times upper limit of laboratory normal
  • All patients must use effective contraception if of reproductive potential. Females must not be pregnant or breast feeding
  • Absence of known HIV infection, chronic hepatitis B or hepatitis C infection
  • Absence of any other serious medical condition that could interfere with follow-up
  • Absence of any medical condition which could interfere with oral medication intake (e.g., frequent vomiting, partial bowel obstruction)
  • Absence of any psychological, familial, sociological or geographical condition potentially hampering compliance with the study protocol and follow-up schedule.
  • Before patient randomization, written informed consent must be given according to ICH/GCP, and national/local regulations.
  • Patients with a buffer range from the normal values of +/- 5% for hematology and +/- 10% for biochemistry are acceptable.
Patients can only be randomized in this trial once.

Exclusion Criteria
Exclusion Criteria Not Available

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