NCT03828227进行中（未招募）3 期
Phase III Study to Evaluate the Quality of Life in Elderly Patients With Metastatic Colorectal Cancer Receiving First-line Therapy Based on Simplified Geriatric Parameters.
GERCOR - Multidisciplinary Oncology Cooperative Group22 个研究点 分布在 1 个国家目标入组 49 人开始时间: 2019年6月14日最近更新:
适应症
干预措施
相关药物
试验速览
- 阶段
- 3 期
- 状态
- 进行中（未招募）
- 发起方
- 入组人数
- 49
- 试验地点
- 22
- 主要终点
- Health-related quality of life (HRQoL) at 6 months in the "candidate group".
研究概览
简要总结
A national, multicenter, open-label, randomized phase III study. The trial aim is to determine the best therapeutic strategies according with the HRQoL.
详细描述
Treatment cohort will be determined based on three parameters:
- Serum albumin level at baseline,
- ECOG Performance Status,
- Mini GDS.
The "Candidate" group will be defined according to (all the following criteria must be fulfilled):
- Serum albumin level ≥ 30g/L,
- ECOG PS 0-1 (whatever mini GDS score) or ECOG PS 2 with mini GDS 0 (ie, no depression).
The "Non-candidate" cohort group will be defined according to (at least one of those parameters is fulfilled):
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Other
- 盲法
- None
入排标准
- 年龄范围
- 75 Years 至 —（Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Signed and dated informed consent, and willing and able to comply with protocol requirements,
- •Histologically proven colorectal adenocarcinoma,
- •Confirmed metastatic disease,
- •Patients with no detected dihydropyridine dehydrogenase (DPD) deficiency,
- •No prior therapy for metastatic disease (in case of previous adjuvant chemotherapy, interval between the end of chemotherapy and relapse must be > 6 months for fluoropyrimidine alone or > 12 months for oxaliplatin-based chemotherapy,
- •Duly documented unresectable metastatic disease i.e., not suitable for complete carcinological surgical resection,
- •Age ≥ 75 years,
- •ECOG PS 0-2,
- •Hematological status: neutrophils ≥ 1.5 x 109/L; platelets ≥ 100 x 109/L, and hemoglobin > 9 g/dL,
- •Adequate renal function: serum creatinine level < 150 µmol/l, and creatinine clearance (Cockcroft and Gault or MDRD formula > 30 mL/min),
- •Adequate liver function: total bilirubin level < 1.5 x upper normal limit (ULN), serum alkaline phosphatase (ALP) level < 5 x ULN,
- •Proteinuria < 2+ (dipstick urinalysis) or ≤ 1g/24h,
- •Regular follow-up feasible. The registered patient must be treated and followed at the participating center,
- •Registration in France with the French National Health Care System (including dispositive PUMA (protection Universelle Maladie).
排除标准
- •History or evidence upon physical examination of CNS metastasis (e.g. non- irradiated CNS metastasis, seizure not controlled with standard medical therapy), unless adequately treated,
- •Neuropathy grade > 1,
- •Patient with known dihydropyridine dehydrogenase (DPD) deficiency or history of severe and unexpected reactions to a fluoropyrimidine-containing regimen, or in case of clinically significant active heart disease or myocardial infarction within 6 months or if patient treated with sorivudine or its clinically related analogues, such as brivudine
- •Uncontrolled hypercalcemia,
- •Uncontrolled hypertension (defined as systolic blood pressure > 150 mmHg and/or diastolic blood pressure > 100 mmHg), or history of hypertensive crisis, or hypertensive encephalopathy,
- •Medical history of other concomitant or previous malignant disease, except adequately treated in situ carcinoma of the uterine cervix, basal or squamous cell carcinoma of the skin, or cancer in complete remission for ≥ 5 years,
- •History of arterial thrombotic and/or embolic event (e.g. myocardial infarction, stroke...) within 6 months prior to randomization,
- •History of abdominal fistula, gastrointestinal (GI) perforation, intra-abdominal abscess or active GI bleeding within 6 months prior to randomization,
- •History or evidence of inherited bleeding diathesis or significant coagulopathy at risk of bleeding,
- •Major surgery (open biopsy, surgical resection, wound revision or any other major surgery involving entry into body cavity) or significant traumatic injury within the last 28 days prior to randomization, and/or minor surgical procedure including placement of a vascular device within 2 days of first study treatment,
- •Concomitant administration of prophylactic phenytoin,
- •Treatment with sorivudine or its chemically related analogues, such as brivudine,
- •Patients with known allergy/hypersensitivity to any component of study drugs
- •Concomitant unplanned anti-tumor treatment,
- •Participation in another clinical trial with any investigational drug within 30 days prior to randomization,
- •Other serious and uncontrolled non-malignant disease,
- •Patient under guardianship, curatorship or under the protection of justice
研究组 & 干预措施
"Candidate group" OPTIMOX plus bevacizumab (Arm A)
Active Comparator
Patients with :
- Serum albumin level ≥ 30g/L,
- ECOG PS 0-1 (whatever mini GDS score) or ECOG PS 2 with mini GDS 0 (ie, no depression).
Adapted FOLFOX7 (aFOLFOX7)-bevacizumab for 6 cycles and then Adapted LV5FU2 (aLV5FU2)-bevacizumab (until progression or or unacceptable limiting toxicity)
干预措施: OPTIMOX-bevacizumab (Drug)
"Candidate group" - Capecitabine-bevacizumab (Arm B)
Active Comparator
Patients with :
- Serum albumin level ≥ 30g/L,
- ECOG PS 0-1 (whatever mini GDS score) or ECOG PS 2 with mini GDS 0 (ie, no depression).
This treatment regimen will be given until disease progression (PD) or unacceptable limiting toxicity, as follows:
干预措施: Capecitabine plus bevacizumab (Drug)
"Non candidate group" - Capecitabine-bevacizumab
Active Comparator
Patients with:
- Serum albumin level < 30g/L.
- And/ or ECOG PS 2 and mini GDS ≥ 1 (ie, depression).
This treatment regimen will be given until disease progression (PD) or unacceptable limiting toxicity, as follows:
干预措施: Capecitabine plus bevacizumab (Drug)
结局指标
主要结局
Health-related quality of life (HRQoL) at 6 months in the "candidate group".
时间窗: At 6 months
Improvement of HRQoL at 6 months by 10 points compared to the score at inclusion on the following targeted dimensions: emotional functioning (4 items) and global health (2 items) (score from 6-30 with higher values representing better quality of life).
次要结局
- Number of patients amenable to second-line therapy.(until 58 months)
- G8 score at baseline.(until 58 months)
- Overall survival (OS)(Until 58 months)
- Other dimensions of health-related quality of life (HRQoL) and longitudinal HRQoL(Until 58 months)
- Number of patient amenable to surgery and/or locoregional therapy.(until 58 months)
- Progression-free survival (PFS)(until 58 months)
- Performance status geriatric (PSG) score.(until 58 months)
- Determination of instrumental activities of daily living (IADL) as prognostic factor for overall survival (OS).(Until 58 months)
研究者
研究点 (22)
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