PER-108-08已完成未知
Intergroup Randomized Phase III Study of Postoperative Oxaliplatin, 5-Fluorouracil and Leucovorin vs Oxaliplatin, 5-Fluorouracil, Leucovorin and Bevacizumab for Patients With Stage II or III Rectal Cancer Receiving Pre-operative Chemoradiation
EASTERN COOPERATIVE ONCOLOGY GROUP (ECOG),0 个研究点目标入组 0 人开始时间: 2008年11月14日最近更新:
适应症
试验速览
- 阶段
- 未知
- 状态
- 已完成
- 发起方
研究概览
简要总结
暂无简介。
研究设计
- 研究类型
- Interventional
入排标准
- 年龄范围
- 18 至 75（—）
- 性别
- All
入选标准
- •Histologically confirmed adenocarcinoma of the rectum meeting 1 of the following clinical (e.g., before neoadjuvant therapy) or pathologic staging criteria: T3, N+, M0, T3, N0, M0, T4, N0, M0, Any T, N1-2, M0
- •T4, N0-2, M0 disease must meet 1 of the following criteria: Clinically fixed tumor on rectal examination with tumor adherent to the pelvic sidewall or sacrum, Hydronephrosis on Computed Tomography (CT) scan or Intravenous Pyelogram (IVP), Ureteric or bladder invasion as documented by cystoscopy and cytology or biopsy, Invasion into prostate, Vaginal or uterine involvement
- •Must have undergone complete tumor resection >= 28 days ago and able to begin treatment by day 56
- •Must have undergone concurrent neoadjuvant chemoradiotherapy*
- •Must have undergone prior radiotherapy at 40-55.8 Gy** AND received 1 of the following chemotherapy regimens: Continuous infusion of fluorouracil with or without oxaliplatin; fluorouracil and leucovorin calcium, Capecitabine with or without oxaliplatin; capecitabine with or without oxaliplatin OR a continuous infusion of fluorouracil with or without oxaliplatin received on protocol NSABP-R-04. NOTE: **Intensity-modulated radiotherapy allowed
- •ECOG performance status 0-1
- •Platelet count >= 100,000/mm^3
- •Absolute granulocyte count >= 1,500/mm^3
- •Bilirubin normal (unless chronic grade 1 bilirubin elevation due to Gilbert´s disease or similar syndrome due to slow conjugation of bilirubin)
- •Alkaline phosphatase (AP) < 2.5 times upper limit of normal (ULN) and aspartate aminotransferase (AST) < 1.5 times ULN
- •Hepatitis B and C negative (for patients with AP > normal) unless previously vaccinated
- •Serum creatinine =< 1.5 times ULN
- •Urine protein: creatinine (UPC) ratio < 1.0 OR urine protein < 1 g on 24-hour urine collection
- •International Normalized Ratio (INR) =< 1.5
- •INR > 1.5 allowed provided patient is on full-dose anticoagulants AND meets all of the following criteria: In-range INR (i.e., between 2 and 3) on a stable dose of warfarin or low molecular weight heparin, No active bleeding or pathological condition that is associated with a high risk of bleeding
- •Negative pregnancy test
- •Fertile patients must use effective contraception during and for at least 3 months after study treatment
- •No other previous or concurrent malignancy except nonmelanoma skin cancer, breast cancer in situ, carcinoma in situ of the cervix, or previously treated nonpelvic cancer that has been disease-free for > 5 years
- •Patients with a history of breast cancer (without evidence of disease) who remain on hormonal therapy for > 5 years are eligible
- •Patients with a history of hypertension must have blood pressure < 150/90 mm Hg AND be on a stable regimen of antihypertensive therapy
- •No other prior chemotherapy or pelvic radiotherapy except as neoadjuvant treatment for current diagnosis of rectal cancer
- •Concurrent participation on protocol NSABP-R-04 allowed
排除标准
- •Pregnant or nursing
- •Evidence of metastatic disease on the surgical/intraoperative examination
- •Evidence of metastatic disease confirmed by CT scan, Magnetic resonance imaging (MRI), or ultrasound of the liver or chest CT scan or chest x-ray within the past 6 months
- •Evidence of tumor outside of the pelvis, including liver metastases, peritoneal seeding, or metastatic inguinal lymphadenopathy
- •Concurrent major surgery
- •Active bleeding not related to the primary rectal tumor within the past 6 months
- •Active inflammatory bowel disease or other serious medical illness which might limit the ability of the patient to receive protocol therapy
- •Active gastroduodenal ulcer determined by endoscopy
- •Serious or nonhealing wound, skin ulcer, or bone fracture
- •Clinically significant peripheral sensory or motor neuropathy >= grade 2
- •Nonmalignant systemic disease (e.g., cardiovascular, renal, or hepatic) that would preclude study treatment including, but not limited to, any of the following: New York Heart Association class III or IV congestive heart failure, Concurrent symptomatic arrhythmia
- •Transient ischemic attack or cerebrovascular accident
- •Arterial thromboembolic event, unstable angina, or myocardial infarction within the past 12 months
- •Significant peripheral vascular disease
- •Psychiatric or addictive disorders or other conditions that, in the opinion of the investigator, would preclude study requirements
- •Significant traumatic injury within the past 28 days
- •Known allergy to platinum compounds
- •Prior invasive procedure, including either of the following: Major surgical procedure or open biopsy within the past 28 days, Core biopsy or other minor procedure, except placement of a vascular access device, within the past 7 days
研究者
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