EUCTR2016-004394-40-IT进行中（未招募）1 期
Randomized phase III study of triplet mFOLFOXIRI plus PANITUMUMAB versus mFOLFOX6 plus PANITUMUMAB as initial therapy for unresectable RAS and BRAF wild-type metastatic colorectal cancer patients - TRIPLETE
Fondazione GONO0 个研究点目标入组 432 人开始时间: 2021年9月10日最近更新:
适应症
相关药物
试验速览
- 阶段
- 1 期
- 状态
- 进行中（未招募）
- 发起方
- 入组人数
- 432
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 colorectal cancer.
- •Initially unresectable metastatic colorectal cancer not previously treated with chemotherapy for metastatic disease.
- •At least one measurable lesion according to RECIST1.1
- •Availability of a tissue tumour sample (primary tumour and/or metastatic sites)
- •Previous adjuvant chemotherapy allowed only if with fluoropyrimidine monotherapy and more than 6 months elapsed between the end of adjuvant and first relapse.
- •RAS (codons 12, 13, 59, 61, 117 and 146 of KRAS and NRAS genes) and BRAF (V600E mutation) wild type status of primary colorectal cancer or related metastasis (local or central laboratory assessment).
- •Are the trial subjects under 18? no
- •Number of subjects for this age range:
- •F.1.2 Adults (18-64 years) yes
- •F.1.2.1 Number of subjects for this age range 300
- •F.1.3 Elderly (>=65 years) yes
- •F.1.3.1 Number of subjects for this age range 132
排除标准
- •Previous treatment for metastatic disease.
- •Radiotherapy to any site within 4 weeks before the study.
- •Previous adjuvant oxaliplatin-containing chemotherapy.
- •Previous treatment with EGFR inhibitors.
- •Untreated brain metastases or spinal cord compression or primary brain tumours.
- •Symptomatic peripheral neuropathy > 1 grade NCIC-CTG criteria.
- •Diagnosis of interstitial pneumonitis or pulmonary fibrosis.
研究者
相似试验
进行中（未招募）
1 期
PHASE III RANDOMIZED STUDY OF FOLFOXIRI PLUS BEVACIZUMAB AND ATEZOLIZUMAB VERSUS FOLFOXIRI PLUS BEVACIZUMAB AS FIRST-LINE TREATMENT OF UNRESECTABLE pMMR AND IMMUNOSCORE IC-HIGH METASTATIC COLORECTAL CANCER PATIENTS. The AtezoTRIBE2 StudyMetastatic colorectal cancerCTIS2023-506632-32-00Gruppo Oncologico Del Nord Ovest238
已完成
3 期
Randomized phase III study of FOLFOX plus bevacizumab versus FOLFIRI plus bevacizumab for metastatic colorectal cancermetastatic colorectal cancerJPRN-UMIN000001396West Japan Oncology Group400
进行中（未招募）
不适用
A PHASE III RANDOMIZED TRIAL OF FOLFOXIRI + BEVACIZUMAB VERSUS FOLFIRI + BEVACIZUMAB AS FIRST-LINE TREATMENT FOR METASTATIC COLORECTAL CANCER - TRIBEMedDRA version: 9.1Level: HLGTClassification code 10017990Term: Malignant and unspecified neoplasms gastrointestinal NECcolorectal cancerEUCTR2008-001537-10-ITG.O.N.O. - GRUPPO ONCOLOGICO NORD OVEST
已完成
3 期
Randomized Phase III Study of mFOLFOX7 or CAPOX plus Bevacizumab versus 5-Fluorouracil/Leucovorin or Capecitabine plus Bevacizumab as First-line Treatment in Elderly Patients with Metastatic Colorectal Cancer (JCOG1018, RESPECT)Metastatic clorectal cancerJPRN-UMIN000008866Japan Clinical Oncology Group (JCOG)250
进行中（未招募）
不适用
Phase III clinical trial of FOLF(HA)iri vs FOLFIRI forsecond or third line therapy in irinotecan-naïve patients with metastaticcolorectal cancerMetastatic colorectal cancer (mCRC)MedDRA version: 17.1Level: LLTClassification code 10052362Term: Metastatic colorectal cancerSystem Organ Class: 100000004864EUCTR2010-020348-36-BGAlchemia Oncology Pty Ltd390