Trial in Low Grade Glioma Patients: Wait or Treat

  • STATUS
    Recruiting
  • End date
    Oct 30, 2031
  • participants needed
    624
  • sponsor
    European Organisation for Research and Treatment of Cancer - EORTC
Updated on 30 September 2021
initial diagnosis
neutrophil count
seizure
temozolomide
astrocytoma

Summary

The 1635-EORTC-BTG study - Wait or Treat - concerns patients that represent a clinically favorable group of patients with IDHmutated astrocytoma (oligo-symptomatic), without a need for immediate post-operative treatment. It will establish whether early adjuvant treatment with radiotherapy and adjuvant temozolomide in resected IDHmutated astrocytoma will improve outcome, and whether benefits of early treatment outweigh potential side-effects of that, such as deterioration in neurocognitive function or Quality of Live, seizure activity and Patient Reported outcome compared to active surveillance.

Details
Condition Low Grade Glioma, Temozolomide, Phase III, Wait or Treat
Treatment Radiotherapy, Temozolomide, Surgery
Clinical Study IdentifierNCT03763422
SponsorEuropean Organisation for Research and Treatment of Cancer - EORTC
Last Modified on30 September 2021

Eligibility

Yes No Not Sure

Inclusion Criteria

Histologically WHO grade II (diffuse) or III (anaplastic) astrocytoma, IDHmt without 1p/19q co-deletion (local diagnosis)
Time since diagnostic surgery or first resection 6 months
No need for immediate radiotherapy followed by chemotherapy
Having seizures only, without functional deficits due to the tumor (but the presence of functional deficits due to the resection is allowed)
Patients for whom by local judgment an active surveillance policy is a realistic management alternative
The patient is at least 18 years of age on day of signing informed consent
WHO PS 0-2
Adequate hematological, renal, and hepatic function, as follows
Absolute neutrophil count 1.5 x 109/L
Platelets 100 109/L
Serum creatinine 1.5 times upper limit of laboratory normal (ULN)
Total serum bilirubin 1.5 ULN
AST and ALT 2.5 ULN
Alkaline phosphatase of 2.5 ULN
Presence of at least one paraffin block from the initial diagnosis for pathology review and translational research. If a representative formalin-fixed, paraffin-embedded (FFPE) block is not available, the collection of optimally 36, minimally 24 x 5 m, unstained slides is required
At the time of randomization presence only of a non-enhancing tumor on T1 weighted contrast enhanced MR images; some faint non-nodular enhancement or enhancement that can be ascribed to the surgical resection or peri-operative ischemia is allowed. Preoperative enhancement is allowed provided this area is resected as shown on postoperative imaging
Ability to take oral medication
Women of child bearing potential (WOCBP) must have a negative serum or urine pregnancy test done within 72 hours prior to randomization
Patients of childbearing / reproductive potential must agree to use adequate birth control measures, as defined by the investigator, during RT and TMZ treatment and for at least 6 months after the last TMZ cycle. A highly effective method of birth control is defined as those which result in low failure rate (i.e., less than 1 percent per year) when used consistently and correctly
Women who are breast feeding must agree to discontinue nursing prior to the first dose of study treatment and until 6 months after the last study treatment
Male patients should be advised not to father a child and not to donate sperm up to 6 months after receiving the last dose of TMZ, and to seek advice on cryoconservation of sperm prior to treatment start
Ability to understand the requirements of the study, provide written informed consent and authorization of use and disclosure of protected health information, and agree to abide by the study restrictions and return for the required assessments
Before patient registration/randomization, written informed consent must be given according to ICH/GCP, and national/local regulations

Exclusion Criteria

Presence of signs of increased intracranial pressure after surgery
Requirement of steroids for control of tumor symptoms
Presence of uncontrolled seizures after surgery, defined as having both
persistent seizures interfering with everyday life activities AND
failed three lines of anti-epileptic drug regimen, including at least one combination regimen
Presence of contra-indications for radiotherapy
Hypersensitivity to dacarbazine (DTIC), to the active substance or to any of the excipients used for TMZ capsules
Prior chemotherapy, or prior radiotherapy to the brain
Pregnancy or breastfeeding
Known HIV, chronic hepatitis B, or hepatitis C infection
Inability to take oral medication (e.g., frequent vomiting, partial bowel obstruction)
Concurrent severe or uncontrolled medical disease (e.g., active systemic infection, diabetes, hypertension, coronary artery disease, psychiatric disorder) that, in the opinion of the investigator, would compromise the safety of the patient or compromise the ability of the patient to complete the study
Prior or second invasive malignancy, except non-melanoma skin cancer, completely resected cervical or prostate cancer (with PSA of less than or equal to 0.1 ng/mL). Other cancers for which the subject has completed potentially curative treatment more than 3 years prior to study entry are allowed
Presence 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
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