ACTRN12611000033943进行中（未招募）2 期
A phase II study of oxaliplatin/5-FU/Avastin and concurrent radiation to determine tolerability in patients with simultaneous primary and metastatic rectal cancer
Peter MacCallum Cancer Centre0 个研究点目标入组 30 人开始时间: 2011年1月10日最近更新:
试验速览
- 阶段
- 2 期
- 状态
- 进行中（未招募）
- 发起方
- 入组人数
- 30
研究概览
简要总结
暂无简介。
研究设计
- 研究类型
- Interventional
- 分配方式
- Non-randomised trial
- 主要目的
- Treatment
- 盲法
- Open (masking not used)
入排标准
- 年龄范围
- 18 Years 至 o limit（—）
- 性别
- All
入选标准
- •1. Patients with previously untreated and pathologically proven adenocarcinoma of the rectum with distant metastasis who would benefit from combined local therapy and systemic chemotherapy.
- •2. Lower border of tumour must be within 15cm of anal verge.
- •3. Age >= 18 years.
- •4. Absolute neutrophil count >= 1.5 x 10^9/L, haemoglobin >= 90 g/L, platelet count >=100 x 10^9/L
- •5. ECOG performance status of <= 2
- •6. Adequate renal function: GFR >= 55 ml/min (using radioisotope renal scan or derived from serum creatinine using the Cockcroft-Gault formula).
- •7. Adequate hepatic function with serum total bilirubin < 1.5 x upper limit of normal range, ALT/AST < 2.5 x UNL in the absence of liver metastases, or < 5 x UNL in the presence of liver metastases, ALP < 2.5 x UNL in the absence of liver metastases, or < 5 x UNL in the presence of liver metastases
- •8. No symptomatic peripheral neuropathy >= grade 2.
- •9. Males or non-pregnant, non-lactating females. Female patients of childbearing potential, not surgically sterilized, must take adequate contraceptive measures.
- •10. Has provided written informed consent for participation in this trial
排除标准
- •1. Prior pelvic radiotherapy
- •2. Febrile intercurrent illness or infection.
- •3. Previous history of unstable angina
- •4. Cardiac arrhythmia which in the opinion of the investigator would compromise the safe delivery of protocol treatment
- •5. Acute coronary syndrome even if controlled with medication
- •6. Myocardial infarction within the last 12 months
- •7. Concurrent treatment with other anti-cancer therapy.
- •8. No medical co-morbidities that have the potential to be exacerbated by or contra-indicate therapy
- •a. Uncontrolled hypertension
- •b. Active bleeding disorders within the last 3 months
- •c. Patients with NYHA Grade III/IV cardiac problems (e.g. congestive heart failure, or myocardial infarction or active myocardial ischemia within 12 months of study)
- •d. Patients with active liver disease (e.g., chronic active hepatitis, cirrhosis).
- •e. Patients with a known diagnosis of human immunodeficiency virus (HIV) infection.
- •f. Patients who have had major surgery within 28 days prior to commencing study drugs
- •g. Patients with a serious non-healing wound, ulcer or bone fracture
- •9. Significant medical condition which in the opinion of the investigator would compromise the planned delivery of the chemotherapy and radiotherapy or which may be potentially exacerbated by these modalities.
- •10. Locally recurrent rectal cancer
- •11. Female patients who are pregnant or breast-feeding
- •12. Medical or psychiatric conditions that compromises the patient's ability to give informed consent or to complete the protocol, or a history of non-compliance
研究者
相似试验
已完成
2 期
A phase II study of oxaliplatin, folinic acid and 5-fluorouracil (modified FOLFOX-6) combination chemotherapy as adjuvant treatment after resection of liver metastases from colorectal cancerliver metastases of colorectal cancerJPRN-UMIN000000996Miyagi HBPCOG50
已完成
1 期
Phase I/II study of the combination of Oxaliplatin and S-1 in patients with advanced/recurrent colorectal cancerunresectable advanced/recurrent colorectal cancerJPRN-C000000443Outpatient Oncology Unit Kyoto University Hospital42
进行中（未招募）
不适用
A randomized phase II study of oxaliplatin and capecitabine combination vs irinotecan and capecitabine combination for the treatment of elderly patients with advanced colorectal cancer.EUCTR2004-001159-12-ITAZIENDA OSPEDALIERA S. CARLO
进行中（未招募）
1 期
Phase 2 trial of neo-adjuvant Oxaliplatin and 5-fluorouracil in oesophageal cancer - Oxali/5FU in Oesophageal CancerOperable oesophageal cancerEUCTR2005-001834-34-GBOxford Radcliffe Hospitals NHS Trust
进行中（未招募）
1 期
Phase II Study of Oxaliplatin / Irinotecan / Bevacizumab Followed by Docetaxel / Bevacizumab in Inoperable Locally Advanced or Metastatic Gastric Cancer Patientsnresectable locally advanced or metastatic Gastric CancerMedDRA version: 20.0Level: PTClassification code 10063916Term: Metastatic gastric cancerSystem Organ Class: 10029104 - Neoplasms benign, malignant and unspecified (incl cysts and polyps)EUCTR2008-006128-79-ATArbeitsgemeinschaft medikamentöse Tumortherapie gemeinnützige GmbH40