TRIAL OF ABVD VS STANFORD V =/- RADIATION THERAPY IN HODGKIN'S DISEASE

本子项目是利用由NIH/NCRR资助的中心赠款提供的资源的众多研究子项目之一。子项目和研究者（PI）可能已经从另一个NIH来源获得了主要资金，因此可以在其他CRISP条目中表示。列出的机构是中心的，不一定是研究者的机构。这是一项用吉西他滨+表柔比星+紫杉醇（GET）原发性化疗治疗局部晚期乳腺癌患者的2期非随机研究。本研究的主要目的是确定临床和病理反应率，并评估该组合的毒性。吉西他滨将在第1天和第4天静脉注射。表柔比星将在第1天静脉注射。紫杉醇将在第1天输注3小时。这个循环将每21天重复一次。治疗将持续到疾病进展，或最多6个周期。达到临床完全缓解（cCR）、部分缓解（PR）或病情稳定（SD）的患者将接受手术治疗。在治疗前和手术中采集的肿瘤样本将被分析分子和遗传变化，并将与肿瘤反应相关联。治疗可在治疗医师或患者自行决定的任何时间停止治疗。在任何无法忍受的毒性或进展性疾病（PD）的情况下应停止治疗。患者必须有组织学证实的乳腺癌诊断，没有转移性疾病的证据。患者必须为IIB （T3）、IIIA或IIIB期乳腺癌或IV期（仅累及锁骨上淋巴结），通过体格检查、乳房x线摄影、超声、MRI、x线或CT扫描确定。患有炎性乳腺癌或具有可测量肿块的乳房或淋巴结浅表病变的患者符合条件。本研究的样本量为76例，以满足置信区间宽度的要求。具体来说，预期病理CR率为15%的95%置信区间应完全在0.05至0.25区间内。也就是说，如果观察到的CR率为15%，则与观察到的CR率在任何方向上的置信区间界限都不应超过0.10。

This subproject is one of many research subprojects utilizing the resources provided by a Center grant funded by NIH/NCRR. The subproject and investigator (PI) may have received primary funding from another NIH source, and thus could be represented in other CRISP entries. The institution listed is for the Center, which is not necessarily the institution for the investigator. This is a Phase 2, nonrandomized study of primary chemotherapy with gemcitabine plus epirubicin plus paclitaxel (GET) in patients with locally advanced breast cancer. The primary aims of this study are to determine the clinical and pathologic response rate and evaluate the toxicity of this combination. Gemcitabine will be administered intravenously on days 1 and 4. Epirubicin will be administered as an intravenous bolus on day 1. Paclitaxel will be administered as a 3-hour infusion on day 1. The cyle will be repeated every 21 days. Treatment will be administered until disease progression, or a maximum of 6 cycles. Patients who acheive clinical complete response (cCR), partial response (PR), or stable disease (SD) will undergo surgery. Tumor samples taken prior to treatment and at surgery will be analyzed for molecular and genetic changes and will be correlated with tumor response. Treatment may be stopped at any time at the discretion of the treating physician or the patient. Treatment should be stopped in any case of intolerable toxicity or progressive disease (PD). Patients must have a hitologically confirmed diagnosis of breast cancer without evidence of metastatic disease. Patients must have Stage IIB (T3), IIIA, or IIIB breast cancer or Stage IV (with involvement of supraclavicular nodes only) determined by physical exam, mammography, sonogram, MRI, x-ray, or CT scan. Patients with inflammatory breast cancer or superficial lesions with a measurable mass in the breast or lymph node are eligible. The sample size for this study, 76 patients, was chosen to satisfy requirements of confidence interval width. Specifically, it was desired that the 95% confidence interval around an anticipated pathological CR rate of 15% should be completely bounded within the interval 0.05 to 0.25. That is, if the observed CR rate is 15%, the confidence interval bounds should be no farther than 0.10 in either direction from the observed rate.