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。子弹和调查员（PI）可能已经从其他NIH来源获得了主要资金，因此可以在其他清晰的条目中代表。列出的机构适用于该中心，这不一定是调查员的机构。这是一项针对吉西他滨加上表皮曲霉素加紫杉醇（GET）的第一阶段，非随机化学研究，对局部晚期乳腺癌患者。这项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天进行静脉内给药。上柔脂素将在第1天以静脉注射为静脉注射。紫杉醇将在第1天以3小时的输液进行给药。每21天将重复每21天。治疗将进行直到疾病进展或最多6个周期。 获得临床完全反应（CCR），部分反应（PR）或稳定疾病（SD）的患者将接受手术。在治疗前和手术时采集的肿瘤样本将进行分子和遗传变化分析，并将与肿瘤反应相关。 治疗医师或患者可以随时停止治疗。在无法忍受的毒性或进行性疾病（PD）的任何情况下，都应停止治疗。 患者必须在没有转移性疾病的情况下对乳腺癌的诊断诊断。患者必须具有通过身体检查，乳房X线摄影，超声检查，MRI，X射线或CT扫描确定的IIB期（T3），IIIA或IIIB乳腺癌或IV期（仅受到锁骨淋巴结的参与）。乳腺癌炎性乳腺癌或表面病变患者乳腺或淋巴结可测量的肿块患者符合条件。这项研究的样本量被选为76例患者，以满足置信区间宽度的要求。具体而言，希望在预期的病理CR率为15％周围的95％置信区间应在0.05至0.25间隔内完全界定。也就是说，如果观察到的CR速率为15％，则置信区间边界应在任何方向上不超过0.10。