NOA-04 Randomized Phase III Trial of Sequential Radiochemotherapy of Anaplastic Glioma With Procarbazine, Lomustine, and Vincristine or Temozolomide

摘要: Purpose The standard of care for anaplastic gliomas is surgery followed by radiotherapy. NOA-04 phase III trial compared efficacy and safety radiotherapy chemotherapy at progression with the reverse sequence in patients newly diagnosed gliomas. Patients Methods (N = 318) were randomly assigned 2:1:1 (A:B1:B2) to receive conventional (arm A); procarbazine, lomustine (CCNU), vincristine (PCV; arm B1); or temozolomide B2) diagnosis. At occurrence unacceptable toxicity disease progression, A treated PCV (1:1 random assignment), whereas arms B1 B2 received primary end point was time treatment failure (TTF), defined as after one either sequence. Results Patient characteristics intention-to-treat population (n 274) balanced between arms. All histologic diagnoses centrally confirmed. Median TTF (...