2024-518740-20-00招募中2 期
FFCD 1605- OPTIPRIME: A phase II study evaluating FOLFOX + panitumumab according to a ‘stop-and-go’ strategy with a reintroduction loop after progression on fluoropyrimidine as maintenance treatment, as the first line in patients with metastatic colorectal adenocarcinoma without a RAS mutation
Fondation Franc.Cancerologie Digestive2 个研究点 分布在 2 个国家目标入组 118 人开始时间: 2024年11月13日最近更新:
相关药物
试验速览
- 阶段
- 2 期
- 状态
- 招募中
- 发起方
- 入组人数
- 118
- 试验地点
- 2
- 主要终点
- Disease control duration.
研究概览
简要总结
Evaluate the disease control duration
研究设计
- 研究类型
- Interventional
入排标准
- 年龄范围
- 18 years 至 65+ years（18-64 Years, 65+ Years）
- 接受健康志愿者
- 否
入选标准
- •Histologically proven colorectal adenocarcinoma without RAS mutation
- •PT > 60%, albumin ≥ 25 g/L
- •Life expectancy ≥ 3 months
- •Patient affiliated to a social security scheme
- •Patient informed and informed consent form signed
- •Confirmed, non-resectable metastatic disease (Stage IV)
- •No prior chemotherapy except perioperative or adjuvant chemotherapy discontinued for more than 12 months
- •At least one measurable metastasis according to the RECIST v1.1 criteria
- •Age ≥ 18 years
- •Neutrophils > 1,500 /mm3, platelets > 100,000/mm3, Hb > 9 g/dL
- •Creatinine clearance > 50 mL/min according to the Cockcroft & Gault formula, 24h proteinuria < 1 g
- •Serum bilirubin < 25 µmol/L, AST, ALT, Alk Phos < 2.5 x ULN or < 5 x ULN in case of liver metastases
排除标准
- •Presence of brain metastases unless controlled
- •Any known specific contraindication or allergy to the medicinal products used in the study (see SmPC Annex 7)
- •Association with the yellow fever vaccine
- •Patient simultaneously included in another clinical trial involving an investigational drug
- •High blood pressure not controlled by medical treatment (PAS > 160 mmHg and/or PAD >90 mmHg)
- •Any progressive disease not stabilised over the past 6 months: hepatic failure, renal failure, respiratory failure
- •The following conditions in the 6 months prior to inclusion: myocardial infarction, severe/unstable angina, coronary artery bypass surgery, congestive heart failure NYHA class II, III or IV, stroke or transient ischaemic attack
- •Patient who has received a transplant, is seropositive for HIV, hepatitis B or hepatitis C or has other immunodeficiency syndromes
- •History of malignant diseases during the past 5 years except basal cell carcinoma of the skin or cervical carcinoma in situ, properly treated
- •QT/QTc interval > 450 msec for men and > 470 msec for women
- •K+ < LLN, Mg2+ < LLN, Ca2+ < LLN
- •RAS mutation (KRAS or NRAS mutation) or BRAF mutation
- •Lack of effective contraception in patients (men and/or women) of childbearing age, pregnant or breastfeeding women, women of childbearing age who have not had a pregnancy test. Women of childbearing potential should agree to use a method of contraception during treatment of the trial and at least 4 months after discontinuation of oxaliplatin therapy, at least 2 months after discontinuation of panitumumab therapy and at least 30 days after discontinuation of 5-fluorouracil or capecitabine. Men must agree to use a method of contraception during treatment and at least 6 months after stopping oxaliplatin therapy and at least 3 months after stopping 5-fluorouracil or capecitabine.
- •Persons in custody or under wardship
- •Impossibility of undergoing medical monitoring during the trial for geographical, social or psychological reasons
- •Patient taking warfarin. If treated with an anticoagulant at the indicated effective dose, this must be replaced with low molecular weight heparin before inclusion
- •Partial or complete DihydroPyrimidine Dehydrogenase (DPD) deficiency (defined as uracilemia ≥16 ng/ml)
- •Peripheral neuropathy > 1 (NCI CTCAE v4.0)
- •Patient with interstitial pneumonitis or pulmonary fibrosis
- •History of chronic diarrhoea or inflammatory disease of the colon or rectum, or obstruction or sub-obstruction during symptomatic treatment
- •Chronic skin disease poorly controlled
- •Treatment with sorivudine or its chemically related analogues such as brivudine
结局指标
主要结局
Disease control duration.
Disease control duration.
次要结局
- The adverse events
- The predictive value of early evolution
- Progression-free survival 1 (PFS1 or PFS)
- Progression-free survival 2 (PFS 2)
- Successive progression-free survivals (PFS3), 4 (PFS4), etc
- The best tumour response
- The early response rate at 6 weeks
- The depth of response
- Overall survival
- Quality of life (EORTC QLQ C-30)
- The dose intensity
- The predictive value of the appearance of resistance mutation(s)
研究者
Coordinator
Scientific
Fondation Franc.Cancerologie Digestive
研究点 (2)
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