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

IRB RTOG 0834

CC CC945

Hospital Main Campus

Stage N/A

Phase Phase 3

Disease Brain

Drug Temozolomide

Description

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

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

Exclusion Criteria Not Available