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Table 1 Visits and assessments in the MecMeth/NOA-24 trial

From: Phase I/II trial of meclofenamate in progressive MGMT-methylated glioblastoma under temozolomide second-line therapy—the MecMeth/NOA-24 trial

  1. *DLT visit will only be performed in phase I. In phase I, visit 2.3 is only performed additionally; if the start of cycle 3 is prolonged for more than 3 days after the DLT visit, all patients in phase II have visit 2.3
  2. **EoT: end of treatment is reached 3 days after last MFA intake (phase I and experimental arm of phase II) or on day 31 of the last TMZ cycle (standard arm of phase II)
  3. ***End of study and of follow-up in the entire trial will be reached when both of the following requirements are fulfilled: (1) at least 6 months after randomization of the last patient in phase II and (2) at least 3 days after definite termination of MFA intake in the last patient receiving MFA therapy (i.e., all patients have concluded study-related MFA intake for more than 3 days)
  4. 1Every 8 weeks: progression assessment, Karnofsky score and QoL, blood samples
  5. 2Na, K, creatinine, ASAT, ALAT, bilirubin
  6. 3Gadolinium-enhanced MRI obtained prior to inclusion/randomization can be used as baseline MRI if the interval between this MRI and the start of study therapy is shorter than 21 days. In patients who have undergone re-resection prior to randomization (only possible in phase II), the MRI used as baseline MRI has to be a postoperative MRI
  7. 4Relapse tumor resection 7–10 days after initiation of study therapy, tissue asservation should take place 2–4 h after the last intake of MFA/TMZ: (1) fresh frozen, (2) 4% PFA, and (3) FFPE tumor material for MFA/MFA metabolite level determination and for analysis of MFA-dependent tissue effects. The exact timepoint of the last MFA intake prior to resection and the exact timepoint of asservation of the tumor material have to be documented
  8. 5Timepoints (to be documented): (a) 2 h after first intake, (b) on the days between MFA start and resection daily blood sampling 2 h after morning application of MFA (optional), and (c) on the day of resection 5 blood samples at an interval of 2 h (0 h (prior to last preOP MFA dose) 2 h, 4 h, 6 h, 8 h later)
  9. 6Only at the first follow-up visit after discontinuation of MFA
  10. 7Only during ongoing MFA treatment + 3 days
  11. 8Only if clinically indicated
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Trials

ISSN: 1745-6215