NCT00137878已完成2 期
A Phase II Randomized Trial Comparing TNFerade™ Biologic With Capecitabine and Radiation Therapy Followed by Surgical Resection Versus Capecitabine and Radiation Therapy Followed by Surgical Resection for the Treatment of Rectal Cancer
适应症
相关药物
试验速览
- 阶段
- 2 期
- 状态
- 已完成
- 发起方
- GenVec
- 试验地点
- 1
研究概览
简要总结
The purpose of this study is to determine if the addition of TNFerade™ to pre-operative chemoradiotherapy increases the number of pathologic complete responses when compared to pre-operative chemoradiotherapy alone as assessed following complete surgical resection of primary rectal cancer.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 主要目的
- Treatment
入排标准
- 年龄范围
- 18 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •All patients who have biopsy proven T3 or T4 rectal cancer which is confined to the primary tumor site with or without regional lymph node involvement
- •Patients must be willing to return for follow-up
- •Patients must be able to give and sign informed consent
- •Patients must be suitable candidates for surgical resection post-chemoradiation, i.e. no history of severe congestive heart failure or severe pulmonary disease
- •Life expectancy > 6 months
排除标准
- •* Patients with evidence of distant metastatic disease
- •* Any of the following hematologic abnormalities: hemoglobin (HGB) \< 8.0 gm/dL unable to be corrected with a transfusion; absolute neutrophil count (ANC) \< 1500 cells/mm3; platelets \< 100,000/mm3; activated partial thromboplastin time (APTT) ratio or International Normalized Ratio (INR) \> 1.5 (except in patients who are therapeutically anticoagulated for non-related medical conditions such as atrial fibrillation and whose anti-thrombotic treatment cannot be withheld for vector injection or surgery).
- •* A history of hepatic cirrhosis or present hepatic dysfunction with total bilirubin \> 2.0 mg/dL except for patients with Gilbert's syndrome who must have a direct bilirubin \/= 2.5 times upper limit of normal.
- •* Renal insufficiency as determined by a serum creatinine \> 2.0 mg/dL
- •* Patients may not have received prior therapy with chemotherapy, biologic therapy or radiation therapy for rectal cancer
- •* Significant history of a medical problem that would preclude the patient from undergoing an operative procedure such as a history of severe congestive heart failure or active ischemic heart disease
- •* Concurrent second malignancy requiring systemic therapy
- •* Pregnant or lactating women
- •* Chronic systemic corticosteroid use
- •* Prior surgery for rectal cancer
- •* Patients with history of deep venous thrombosis or pulmonary embolism
- •* Patients with Doppler evidence of deep venous thrombosis at screening
- •* Known history of documented coagulopathy or thrombophilic disorders
- •* Hormone replacement therapy within one month prior to Day 1
- •* Known history of documented cerebrovascular disease, stroke or transient ischemic attack (TIA)
- •* Surgery within the last one month, excluding diverting colostomy or ileostomy for obstruction
研究者
研究点 (1)
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