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

ABVD 与 STANFORD V 的试验 =/- 霍奇金病的放射治疗

• 批准号: 7376319
• 负责人: ALAN D MILLER
• 金额: $ 0.06万
• 依托单位: TULANE UNIVERSITY OF LOUISIANA
• 依托单位国家: 美国
• 财政年份: 2005
• 资助国家: 美国
• 起止时间: 2005-12-01 至 2006-11-30
• 项目状态: 已结题
• 来源: https://reporter.nih.gov/project-details/7376319
• 关键词: TRIAL; ABVD; VS; STANFORD; RADIATION

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.

该子项目是利用NIH/NCRR资助的中心赠款提供的资源的许多研究子项目之一。子项目和研究者（PI）可能从另一个NIH来源获得主要资金，因此可以在其他CRISP条目中表示。所列机构为中心，不一定是研究者所在机构。这是一项在局部晚期乳腺癌患者中进行的吉西他滨+表阿霉素+紫杉醇（GET）初级化疗的II期、非随机研究。本研究的主要目的是确定临床和病理学反应率，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。第1天将静脉推注给予依匹鲁肽。将在第1天以3小时输注方式给予紫杉醇。该周期将每21天重复一次。治疗将持续至疾病进展或最多6个周期。 达到临床完全缓解（cCR）、部分缓解（PR）或疾病稳定（SD）的患者将接受手术。将分析治疗前和手术时采集的肿瘤样本的分子和遗传变化，并将其与肿瘤缓解相关。 治疗可由治疗医生或患者自行决定在任何时间停止治疗。如果出现无法耐受的毒性或疾病进展（PD），应停止治疗。 患者必须有乳腺癌的组织学确诊，无转移性疾病的证据。患者必须患有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、超声检查、MRI、X线或CT扫描确定。患有炎症性乳腺癌或乳房或淋巴结有可测量肿块的浅表病变的患者有资格。选择本研究的样本量（76例患者）以满足置信区间宽度的要求。具体而言，预期病理CR率为15%的95%置信区间应完全限定在0.05 - 0.25区间内。也就是说，如果观察到的CR率为15%，则置信区间界限在任一方向上与观察到的CR率的距离均不应超过0.10。