A Phase II Study of Postoperative Intensity Modulated Radiation Therapy (IMRT) With Concurrent Cisplatin and Bevacizumab Followed by Carboplatin and Paclitaxel for Patients With Endometrial Cancer
试验速览
- 阶段
- 2 期
- 状态
- 已完成
- 入组人数
- 34
- 试验地点
- 41
- 主要终点
- Percentage of Participants With Treatment-related, Grade 3+, Non-hematologic Adverse Events Occuring Within 90 Days After Treatment Start
研究概览
简要总结
This phase II trial studies the side effects of giving intensity-modulated radiation therapy together with cisplatin and bevacizumab followed by carboplatin and cisplatin and to see how well they work in treating patients who have undergone surgery for high-risk endometrial cancer. Specialized radiation therapy that delivers a high dose of radiation directly to the tumor may kill more tumor cells and cause less damage to normal tissue. Drugs used in chemotherapy, such as cisplatin, carboplatin, and paclitaxel, work in different ways to stop the growth of tumor cells, either by killing the cells or by stopping them from dividing. Monoclonal antibodies, such as bevacizumab, can block the ability of tumor cells to grow and spread. Bevacizumab may also stop the growth of tumor cells by blocking blood flow to the tumor. Giving intensity-modulated radiation therapy together with chemotherapy and bevacizumab after surgery may kill any tumor cells that remain after surgery.
详细描述
PRIMARY OBJECTIVE:
I. To assess the treatment-related, grade 3+, non-hematologic adverse-event rate within 90 days from the start of treatment with concurrent intensity-modulated radiotherapy, cisplatin, and bevacizumab followed by carboplatin and paclitaxel in patients with high-risk endometrial cancer.
SECONDARY OBJECTIVES:
I. To evaluate treatment-related adverse events occurring within 1 year from the start of treatment.
II. To evaluate all treatment-related adverse events. III. To evaluate disease-free and overall survival. IV. To evaluate local, regional, and distant failure.
研究设计
- 研究类型
- Interventional
- 分配方式
- Na
- 干预模型
- Single Group
- 主要目的
- Treatment
- 盲法
- None
入排标准
- 年龄范围
- 18 Years 至 —（Adult, Older Adult）
- 性别
- Female
- 接受健康志愿者
- 否
入选标准
- •Histologically confirmed endometrial cancer, including 1 of the following cellular types:
- •Endometrioid endometrial adenocarcinoma
- •Clear cell carcinoma
- •Papillary serous adenocarcinoma
- •Adenosquamous cell carcinoma
- •Other adenocarcinoma variant
- •No carcinosarcoma
- •Meets 1 of the following criteria:
- •Grade 3 carcinoma with > 50% myometrial invasion (stage IC or IIA) (all papillary serous or clear cell carcinoma will be considered grade 3)
- •Grade 2 or 3 carcinoma with any cervical stromal invasion (stage IIB)
- •Known extra-uterine disease confined to the pelvis (stage III or IVA)
- •Patients with stage III or IVA disease must have undergone computed tomography (CT) scan or positron emission tomography (PET)/CT scan of the abdomen and pelvis within the past 56 days
- •Has undergone hysterectomy (i.e., total abdominal, vaginal, robotic-assisted, radical, or laparoscopic-assisted vaginal hysterectomy) and bilateral salpingo-oophorectomy within the past 56 days
- •No positive common iliac or positive para-aortic nodal disease (defined as lymph nodes ? 2 cm in any dimension on CT scan or biopsy) or positive peritoneal cytology
- •No evidence of metastatic extrauterine disease, gross or residual disease (not including pelvic nodal disease), or distant metastases
- •Zubrod performance status 0-1
- •Absolute neutrophil count (ANC) ? 1,500/mm^3 (without growth factor support)
- •Platelet count ? 100,000/mm^3
- •Hemoglobin ? 10 g/dL (transfusion allowed)
- •Total bilirubin ? 1.5 times upper limit of normal (ULN)
- •Aspartate aminotransferase (AST) and alanine aminotransferase (ALT) ? 2 times ULN
- •Serum creatinine ? 1.5 mg/dL
- •Urine protein:creatinine ratio ? 0.5 OR urine protein < 1,000 mg on 24-hour urine collection
- •International normalized ratio (INR) < 1.5 (for patients treated with warfarin within the past 14 days)
- •Not nursing
- •No neuropathy ? Common Terminology Criteria for Adverse Events (CTCAE) grade 1
- •No ototoxicity > CTCAE grade 2
- •No serious, active comorbidity, including any of the following:
- •Unstable angina and/or New York Heart Association (NYHA) class II-IV congestive heart failure requiring hospitalization within the past 12 months
- •Transmural myocardial infarction within the past 12 months
- •Acute bacterial or fungal infection requiring IV antibiotics
- •Chronic obstructive pulmonary disease exacerbation or other respiratory illness requiring hospitalization or precluding study therapy
- •Hepatic insufficiency resulting in clinical jaundice and/or coagulation defects
- •Acquired immune deficiency syndrome (AIDS) based upon current Center for Disease Control (CDC) definition (human immunodeficiency virus [HIV] testing is not required)
- •Active gastrointestinal (GI) ulcers, GI bleeding, inflammatory bowel disease, or GI obstruction
- •Inadequately controlled hypertension, defined as systolic blood pressure (BP) > 150 mm Hg and/or diastolic BP > 90 mm Hg on antihypertensive medications
- •Significant vascular disease, including aortic aneurysm, aortic dissection, or arteriovenous malformation within the past 12 months
- •Serious cardiac arrhythmia on medication (well-controlled atrial fibrillation on medication allowed)
- •Serious non-healing wound, ulcer, or bone fracture
- •No history of hypertensive crisis or hypertensive encephalopathy
- •No stroke/cerebrovascular event within the past 12 months
- •No arterial thromboembolic events, including transient ischemic attack or clinically symptomatic peripheral artery disease within the past 12 months
- •No abdominal fistula, GI perforation, or intra-abdominal abscess within the past 6 months
- •No other invasive malignancies within the past 3 years other than nonmelanomatous skin cancer
- •No significant trauma within the past 28 days
- •No mental status changes or bladder problems that would preclude the ability to comply with bladder-filling instructions
- •No mental or psychiatric illness that would preclude giving informed consent
- •No known hypersensitivity to Chinese hamster ovary cell products or other recombinant human antibodies
- •No prior allergic reaction to bevacizumab, cisplatin, carboplatin, or paclitaxel
- •No concurrent erythropoietin, St. John's wort, therapeutic anticoagulants, aminoglycoside antibiotics, or amifostine
- 另有 9 项未显示
排除标准
- 未提供
研究组 & 干预措施
Treatment (IMRT, cisplatin,bevacizumab,carboplatin,paclitaxel)
Patients undergo pelvic IMRT once daily, 5 days a week, for 5 weeks. Patients may also undergo optional nodal boost radiotherapy and/or vaginal brachytherapy boost. Patients also receive concurrent cisplatin IV over 1 hour on days 1 and 29 and bevacizumab IV over 30-90 minutes on days 1, 15, and 29. Beginning 4-6 weeks after completing IMRT, cisplatin, and bevacizumab, patients receive carboplatin IV over 1 hour and paclitaxel IV over 3 hours on day 1. Treatment with carboplatin and paclitaxel repeats every 21 days for 4 courses in the absence of disease progression or unacceptable toxicity.
干预措施: Bevacizumab (Biological)
Treatment (IMRT, cisplatin,bevacizumab,carboplatin,paclitaxel)
Patients undergo pelvic IMRT once daily, 5 days a week, for 5 weeks. Patients may also undergo optional nodal boost radiotherapy and/or vaginal brachytherapy boost. Patients also receive concurrent cisplatin IV over 1 hour on days 1 and 29 and bevacizumab IV over 30-90 minutes on days 1, 15, and 29. Beginning 4-6 weeks after completing IMRT, cisplatin, and bevacizumab, patients receive carboplatin IV over 1 hour and paclitaxel IV over 3 hours on day 1. Treatment with carboplatin and paclitaxel repeats every 21 days for 4 courses in the absence of disease progression or unacceptable toxicity.
干预措施: Carboplatin (Drug)
Treatment (IMRT, cisplatin,bevacizumab,carboplatin,paclitaxel)
Patients undergo pelvic IMRT once daily, 5 days a week, for 5 weeks. Patients may also undergo optional nodal boost radiotherapy and/or vaginal brachytherapy boost. Patients also receive concurrent cisplatin IV over 1 hour on days 1 and 29 and bevacizumab IV over 30-90 minutes on days 1, 15, and 29. Beginning 4-6 weeks after completing IMRT, cisplatin, and bevacizumab, patients receive carboplatin IV over 1 hour and paclitaxel IV over 3 hours on day 1. Treatment with carboplatin and paclitaxel repeats every 21 days for 4 courses in the absence of disease progression or unacceptable toxicity.
干预措施: Cisplatin (Drug)
Treatment (IMRT, cisplatin,bevacizumab,carboplatin,paclitaxel)
Patients undergo pelvic IMRT once daily, 5 days a week, for 5 weeks. Patients may also undergo optional nodal boost radiotherapy and/or vaginal brachytherapy boost. Patients also receive concurrent cisplatin IV over 1 hour on days 1 and 29 and bevacizumab IV over 30-90 minutes on days 1, 15, and 29. Beginning 4-6 weeks after completing IMRT, cisplatin, and bevacizumab, patients receive carboplatin IV over 1 hour and paclitaxel IV over 3 hours on day 1. Treatment with carboplatin and paclitaxel repeats every 21 days for 4 courses in the absence of disease progression or unacceptable toxicity.
干预措施: Intensity-Modulated Radiation Therapy (Radiation)
Treatment (IMRT, cisplatin,bevacizumab,carboplatin,paclitaxel)
Patients undergo pelvic IMRT once daily, 5 days a week, for 5 weeks. Patients may also undergo optional nodal boost radiotherapy and/or vaginal brachytherapy boost. Patients also receive concurrent cisplatin IV over 1 hour on days 1 and 29 and bevacizumab IV over 30-90 minutes on days 1, 15, and 29. Beginning 4-6 weeks after completing IMRT, cisplatin, and bevacizumab, patients receive carboplatin IV over 1 hour and paclitaxel IV over 3 hours on day 1. Treatment with carboplatin and paclitaxel repeats every 21 days for 4 courses in the absence of disease progression or unacceptable toxicity.
干预措施: Paclitaxel (Drug)
结局指标
主要结局
Percentage of Participants With Treatment-related, Grade 3+, Non-hematologic Adverse Events Occuring Within 90 Days After Treatment Start
时间窗: From start of treatment to 90 days
Adverse events are graded using CTCAE v4.0. Grade refers to the severity of the AE, assigning Grades 1 through 5 with unique clinical descriptions of severity for each AE based on this general guideline: Grade 1 Mild AE, Grade 2 Moderate AE, Grade 3 Severe AE, Grade 4 Life-threatening or disabling AE, Grade 5 Death related to AE.
次要结局
- Treatment-related Grade 3+ Adverse Events(From start of treatment to end of follow-up, up to 43.4 months; analysis occurred after all patients had been on study for at least one year.)
- Overall Survival (Two-year Rate Reported)(From registration to two years)
- Disease-free Survival (Two-year Rate Reported)(From registration to two years)
- Pelvic Failure Rate (Two-year Rate Reported)(From registration to two years)
- Percentage of Participants With Treatment-related, Grade 3+, Non-hematologic Adverse Events Occuring Within 1 Year After Treatment Start(From start of treatment to one year)
- Distant Failure (Two-year Rate Reported)(From registration to two years)