Department of Radiotherapy, IRCCS AUO San Martino - IST - National Institute for Cancer Research, Genoa, Italy.
Anticancer Res. 2012 Apr;32(4):1533-6.
To assess the impact of a two-step multiparameter selection on the actual enrollment of women with breast cancer into a prospective intraoperative radiotherapy (IORT) trial.
From September 2009, a prospective clinical trial was started in order to deliver adjuvant exclusive single -fraction IORT to patients with early breast cancer. To select patients meeting suitable eligibility criteria for the clinical trial, a two-step decision process was developed: at pre-surgical examination (first step) and during surgery (second step).
A series of 464 patients with breast cancer was analysed: at the first step, out of 464 patients, 333 (71%) were considered eligible for the IORT protocol; at the second step, out of 333 patients, 199 (60%) met the eligibility criteria and received the IORT fraction according to the criteria of the controlled trial.
In our experience, the ultimate rate of patients who enrolled in the IORT clinical trial after the two-step decision process was 43%.
评估两步多参数选择对入组前瞻性术中放疗（IORT）试验的乳腺癌女性实际人数的影响。
自 2009 年 9 月起，为了给早期乳腺癌患者提供辅助性单次分割 IORT，开始了一项前瞻性临床试验。为了选择符合临床试验入选标准的患者，制定了两步决策过程：术前检查（第一步）和手术期间（第二步）。
分析了一系列 464 例乳腺癌患者：在第一步中，464 例患者中有 333 例（71%）被认为符合 IORT 方案的入选标准；在第二步中，333 例患者中有 199 例（60%）符合入选标准，并按照对照试验的标准接受了 IORT 剂量。
根据我们的经验，经过两步决策过程后，入组 IORT 临床试验的患者最终比例为 43%。
