OPEN-LABEL PHASE II STUDY OF INDUCTION TREATMENT WITH FOLFOXIRI PLUS BEVACIZUMAB FOLLOWED BY PREOPERATIVE CHEMORADIOTHERAPY PLUS BEVACIZUMAB IN PATIENTS WITH LOCALLY ADVANCED, RESECTABLE RECTAL CANCER - TRUST

ARCO0 个研究点开始时间: 2012年3月2日最近更新: 2012年8月28日

试验速览

阶段: 不适用
状态: 进行中（未招募）
发起方: ARCO

研究概览入排标准研究者记录与标识符相似试验

研究概览

简要总结

暂无简介。

研究设计

研究类型: Interventional clinical trial of medicinal product

入排标准

性别: All

入选标准

•- Histologically proven diagnosis of rectal adenocarcinoma. Diagnosis obtained by a biopsy technique which leaves the major portion of the tumor intact. - Locally advanced, resectable disease defined by the presence of at least one of the following features: tumour extending to within 1 mm of or beyond the mesorectal fascia (ie, circumferential radial margin threatened or involved); lower third (= 6 cm from the anal verge) cT3 tumours; tumour extending 5 mm or more into perirectal fat; T4 tumour (ie, invading surrounding structures or peritoneum); clinical stage III disease (T1-4, N1-2), with the definition of a clinically positive lymph node being any node = 1.0 cm; - Distal border of the tumor must be located < 12 cm from the anal verge. - No evidence of metastatic disease by CT scan of the chest and abdomen and total body PET-CT scan. - Tumor must be amenable to curative resection (curative resection can include pelvic exenteration). - No history of invasive rectal malignancy, regardless of disease-free interval. - No other rectal cancers (i.e., sarcoma, lymphoma, carcinoid, squamous cell carcinoma, or cloacogenic carcinoma) or synchronous colon cancer. - No clear indication of involvement of the pelvic side walls by imaging. - Age between 18 and 75 years. - ECOG Performance status < 2 if age < 70 years and = 0 if age 71-75 years. - Life expectancy of at least 5 years (excluding diagnosis of cancer). - Hematopoietic: absolute neutrophil count = 1,000/mm3; platelet count = 100,000/mm3; haemoglobin level = 10 g/dL. - Hepatic: total bilirubin = 1.5 times upper limit of normal (ULN); alkaline phosphatase = 2 times ULN; AST = 2 times ULN. [Note: *If AST>ULN, serologic testing for Hepatitis B and C must be negative]. - Renal: creatinine clearance > 50 mL/min; no renal disease that would preclude study treatment or follow-up. -Written informed consent to experimental treatment and pharmacogenomic analyses.
•Are the trial subjects under 18? no
•Number of subjects for this age range: 0
•F.1.2 Adults (18-64 years) yes
•F.1.2.1 Number of subjects for this age range 38
•F.1.3 Elderly (>=65 years) yes
•F.1.3.1 Number of subjects for this age range 5

排除标准

•- Previous treatment with oxaliplatin, irinotecan or bevacizumab. Previous 5-fluorouracil or capecitabine treatment is allowed. - Previous pelvic radiation therapy. - Hepatic disease that would preclude study treatment or follow-up; uncontrolled coagulopathy; history of viral hepatitis or other chronic liver disease. - Cardiovascular disease that would preclude study treatment or follow-up; New York Heart Association class III or IV heart disease; active ischemic heart disease; myocardial infarction within the past 6 months; symptomatic arrhythmia; uncontrolled hypertension. - Lack of upper gastrointestinal tract integrity or malabsorption syndrome; active inflammatory bowel disease (i.e., patients requiring current medical interventions or who are symptomatic). - Pregnant or lactating women. Fertile patients must use effective contraception. - Patients with prior malignancies (with the exception of rectal cancer), including invasive colon cancer, are eligible provided they have been disease-free for = 5 years and are deemed by their physician to be at low risk for recurrence. - Other malignancy within the past 5 years with the exception of effectively treated squamous cell or basal cell skin cancer, melanoma in situ, carcinoma in situ of the cervix, or carcinoma in situ of the colon or rectum. - Known hypersensitivity to fluorouracil, oxaliplatin or irinotecan or to Chinese hamster ovary cell proteins. - Clinically significant peripheral neuropathy (i.e., neurosensory or neuromotor toxicity = grade 2). - Psychiatric or addictive disorders, or other conditions that, in the opinion of the investigator, would preclude study participation

研究者

发起方

ARCO

相似试验

进行中（未招募）

1 期

An open label phase II study to evaluate the efficacy and safety of Inotuzumab Ozogamicin for Induction Therapy followed by a conventional chemotherapy based consolidation and maintenance therapy In patients aged 56 years and older with Acute Lymphoblastic leukemia (ALL).Acute lymphoblastic leukemia, Philadelphia-chromosome and BCR-ABL negative disease, patient aged 56 years or olderMedDRA version: 21.0Level: LLTClassification code 10000845Term: Acute lymphoblastic leukemiaSystem Organ Class: 100000004864

EUCTR2016-004836-39-DEGoethe Universität45

进行中（未招募）

1 期

An open label phase II study to find out if the drug PDR001 is safe and has beneficial effects in patient who have advanced or metastatic nonfunctional neuroendocrine tumors of pancreatic, gastrointestinal, thoracic origins or poorly-differentiated gastroenteropancreatic neuroendocrine carcinoma (GEP-NEC) and have progressed on prior treatmentAdvanced neuroendocrine tumor (NET) of pancreatic, GI lung origin or poorly-differentiated gastroenteropancreatic neuroendocrine carcinoma (GEP-NEC), that have progressed on prior treatmentMedDRA version: 21.0Level: PTClassification code 10052399Term: Neuroendocrine tumourSystem Organ Class: 10029104 - Neoplasms benign, malignant and unspecified (incl cysts and polyps)

EUCTR2016-002522-36-SEovartis Pharma AG110

进行中（未招募）

1 期

An open label phase II study to find out if the drug PDR001 is safe and has beneficial effects in patient who have advanced or metastatic nonfunctionalneuroendocrine tumors of pancreatic, gastrointestinal, thoracic origins or poorly-differentiated gastroenteropancreatic neuroendocrine carcinoma (GEP-NEC) and have progressed on prior treatmentAdvanced neuroendocrine tumor (NET) of pancreatic, GI or lung originMedDRA version: 21.0Level: PTClassification code 10052399Term: Neuroendocrine tumourSystem Organ Class: 10029104 - Neoplasms benign, malignant and unspecified (incl cysts and polyps)

EUCTR2016-002522-36-ITOVARTIS PHARMA AG116

进行中（未招募）

1 期

An open label phase II study to find out if the drug PDR001 is safe and hasbeneficial effects in patient who have advanced or metastatic nonfunctionalneuroendocrine tumors of pancreatic, gastrointestinal, thoracicorigins or poorly-differentiated gastroenteropancreatic neuroendocrinecarcinoma (GEP-NEC) and have progressed on prior treatmentAdvanced neuroendocrine tumor (NET) of pancreatic, GI lung origin orpoorly-differentiated gastroenteropancreatic neuroendocrine carcinoma(GEP-NEC), that have progressed on prior treatmentMedDRA version: 20.0Level: PTClassification code 10052399Term: Neuroendocrine tumourSystem Organ Class: 10029104 - Neoplasms benign, malignant and unspecified (incl cysts and polyps)

EUCTR2016-002522-36-DEovartis Pharma AG110

进行中（未招募）

1 期

An open label phase II study to find out if the drug PDR001 is safe and has beneficial effects in patient who have advanced or metastatic non-functional neuroendocrine tumors of pancreatic, gastrointestinal, or thoracic origins and have progressed on prior treatmentAdvanced neuroendocrine tumor (NET) of pancreatic, GI or lung originMedDRA version: 19.1Level: PTClassification code 10052399Term: Neuroendocrine tumourSystem Organ Class: 10029104 - Neoplasms benign, malignant and unspecified (incl cysts and polyps)

EUCTR2016-002522-36-FRovartis Pharma AG90