ISRCTN87163246已完成2 期
Fluoropyrimidine, Oxaliplatin and Targeted Receptor pre-Operative Therapy: a controlled trial in high-risk operable colon cancer
niversity of Birmingham (UK)0 个研究点目标入组 1,050 人开始时间: 2007年3月30日最近更新:
适应症
试验速览
- 阶段
- 2 期
- 状态
- 已完成
- 发起方
- 入组人数
- 1,050
研究概览
简要总结
2012 Interim results article in http://www.ncbi.nlm.nih.gov/pubmed/23017669 Pilot/feasibility results results 2023 Results article in https://pubmed.ncbi.nlm.nih.gov/36657089/ (added 20/01/2023)
研究设计
- 研究类型
- Interventional
入排标准
- 性别
- All
入选标准
- •Current inclusion criteria as of 26/01/2018:
- •1. Histologically proven adenocarcinoma of the colon or high grade dysplasia on histology plus unequivocal radiological evidence of invasive cancer
- •2. A candidate for adjuvant oxaliplatin/ fluoropyrimidine chemotherapy based on:
- •2.1. Either radiological high risk (rT4 or rT3 tumour with extramural extension = 5mm)
- •2.2. Or radiological intermediate risk (rT3 tumour with <5mm extramural extension) and younger age/good general health
- •3. Patients presenting with acute colonic obstruction may enter the trial only after obstruction is relieved by a successful defunctioning stoma, and when recovered to a fitness level consistent with the other eligibility criteria
- •4. Adequate full blood count: WBC >3.0 x109/l; Plts >100 x109/l. Anaemia (Hb < 10.0 g/dl) is not an exclusion, but should be corrected by transfusion prior to surgery and chemotherapy. If Hb remains low despite transfusions, surgery and chemotherapy can be given at the decision of the surgical and oncology teams.
- •5. Adequate renal biochemistry: GFR >50 ml/min calculated by the Wright or Cockroft formula or EDTA clearance >70 ml/min
- •6. Adequate hepatobiliary function: bilirubin < 25 µmol/l (Patients with Gilbert’s syndrome who have raised bilirubin but otherwise normal liver function tests are eligible for the study.)
- •7. Aged 18 or over
- •8. WHO performance status of 0, 1 or 2
- •9. If female and of childbearing potential, must:
- •9.1. Have a negative pregnancy test =72hours prior to initiating study treatment
- •9.2. Agree to avoid pregnancy during and for 6 months after study treatment
- •10. If male with a partner of childbearing potential, must:
- •-Agree to use adequate, medically approved, contraceptive precautions during and for 90 days after the last dose of study treatment
- •11.Patient able and willing to provide written informed consent for the study
- •Previous inclusion criteria:
- •1. Histologically proven colon cancer with a radiological staging of T3, NX, M0
- •2. Computed Tomography (CT) scan criteria of poor prognosis (T4 or T3 and more than 5 mm extramural depth and/or probable nodal involvement and/or probable vascular invasion)
- •3. Fit for the neoadjuvant treatments
- •4. Patients who have presented with acute colonic obstruction if a successful defunctioning or stent procedure has been performed
- •5. Patients able and willing to provide written informed consent for the study
排除标准
- •Current exclusion criteria as of 26/01/2018:
- •1. MorbidityAny patient for whom radiotherapy is advised by the MDT
- •2. Strong evidence of distant metastases or peritoneal nodules (M1)
- •3. Peritonitis (secondary to perforated tumour)
- •4. Colonic obstruction that has not been defunctioned
- •5. Serious medical comorbidity, eg uncontrolled inflammatory bowel disease, uncontrolled angina or recent (<6 months) MI
- •6. Another serious medical condition judged to compromise ability to tolerate neoadjuvant therapy and/or surgery
- •7. Any other malignant disease within the preceding 5 years with the exception of non-melanomatous skin cancer, carcinoma in situ and early stage disease with a recurrence risk <5%
- •Additional exclusion criteria for panitumumab randomisation
- •1. RAS-mutant or unknown RAS status tumours
- •2. Allocated post-operative chemotherapy
- •3. History of interstitial pneumonitis or pulmonary fibrosis
- •4. History of severe or life-threatening hypersensitivity reactions
- •5. Serum magnesium levels within the normal range at trial entry (which can include intravenous correction)
- •Previous exclusion criteria:
- •1. Tumour within 15 cm of the anal verge as judged by sigmoidoscopy, or below the level of the sacral promontory, as judged by sagittal CT
- •2. Indication for radiotherapy
- •3. Evidence of disseminated disease (M1)
- •4. Peritonitis (secondary to perforated tumour)
- •5. Under the age of 18 or pregnant
- •6. Serious medical co-morbidity
研究者
相似试验
进行中（未招募）
1 期
Fluoropyrimidine, Oxaliplatin & Targeted Receptor pre-Operative Therapy for colon cancer: A randomised trial assessing whether preoperative chemotherapy and/or an anti-EGFR monoclonal antibody improve outcome in high-risk operable colon cancer - FOxTROTPatients with high-risk, operable colon cancerMedDRA version: 14.1Level: PTClassification code 10009955Term: Colon cancer stage IIISystem Organ Class: 10029104 - Neoplasms benign, malignant and unspecified (incl cysts and polyps)MedDRA version: 14.1Level: PTClassification code 10009956Term: Colon cancer stage IVSystem Organ Class: 10029104 - Neoplasms benign, malignant and unspecified (incl cysts and polyps)EUCTR2007-001987-55-SEniversity Of Birmingham20
进行中（未招募）
1 期
Fluoropyrimidine, Oxaliplatin & Targeted Receptor pre-Operative Therapy for colon cancer: A randomised trial assessing whether preoperative chemotherapy and/or an anti-EGFR monoclonal antibody improve outcome in high-risk operable colon cancer - FOxTROTPatients with high-risk, operable colon cancerMedDRA version: 14.1Level: PTClassification code 10009955Term: Colon cancer stage IIISystem Organ Class: 10029104 - Neoplasms benign, malignant and unspecified (incl cysts and polyps)MedDRA version: 14.1Level: PTClassification code 10009956Term: Colon cancer stage IVSystem Organ Class: 10029104 - Neoplasms benign, malignant and unspecified (incl cysts and polyps)EUCTR2007-001987-55-DKniversity Of Birmingham150
进行中（未招募）
1 期
A trial looking at chemotherapy and panitumumab before and after surgery for bowel cancer (FOxTROT)Patients with high-risk, operable colon cancerMedDRA version: 19.0Level: PTClassification code 10009955Term: Colon cancer stage IIISystem Organ Class: 10029104 - Neoplasms benign, malignant and unspecified (incl cysts and polyps)MedDRA version: 19.0Level: PTClassification code 10009956Term: Colon cancer stage IVSystem Organ Class: 10029104 - Neoplasms benign, malignant and unspecified (incl cysts and polyps)EUCTR2007-001987-55-GBniversity Of Birmingham1,050
终止
1 期
Oxaliplatin, Fludarabine, and Cytarabine in Acute Myeloid Leukemia (AML) or High-Risk Myelodysplastic Syndromes (MDS)Myelodysplastic SyndromesLeukemiaAcute Myeloid LeukemiaNCT00480987M.D. Anderson Cancer Center27
已完成
2 期
Combination Chemotherapy in Treating Patients With Metastatic Colorectal Cancer Previously Treated With IrinotecanColorectal CancerNCT00016978National Cancer Institute (NCI)40