An Observational Study to Evaluate the Safety and Efficacy of FOLFIRI / FOLFOX Plus Cetuximab as First-line Therapy in Patients With KRAS Wild-type Metastatic Colorectal Cancer
研究概览
详细说明
Cetuximab, a chimeric immunoglobulin G1 (IgG1) monoclonal antibody, has been found to potentiate the effects of chemotherapy and radiotherapy in experimental systems. The findings from clinical trials suggest a favorable risk-benefit ratio of the combination of irinotecan or oxaliplatin, infusional 5-FU/FA and biweekly cetuximab, and support the current study to demonstrate the therapeutic value of the biweekly cetuximab regimen as a combination partner for those regimens in subjects with KRAS wild-type mCRC in the first-line setting. The purpose of this study is to generate post marketing surveillance (PMS) data for cetuximab in first-line mCRC, which is mandated by the Licensing Authorities.
This is an open-label, non-randomized, prospective, multicentric Phase IV study evaluating FOLFIRI/ FOLFOX plus cetuximab in the first-line therapy of subjects with KRAS wild-type metastatic CRC. The study plans to enroll 100 subjects with KRAS wild type CRC at 20 centres across India. Tumour status, physical and laboratory examinations will be performed during the baseline visit. Subjects will be administered FOLFIRI/ FOLFOX and cetuximab according to the clinical condition in the following treatment visits. Regular safety assessments and all adverse events (AEs) will be documented throughout and until the end-of-study visit. The outcome of AEs ongoing at the final tumour assessment visit will be followed up at the end-of-study visit (If possible, 6 weeks after the last administration of study medication but before second-line anticancer treatment, and not earlier than 30 days after the end of study treatment). Skin toxicity present at the end-of-study visit will be followed up until outcome is known.
OBJECTIVES
Primary Objective:
- To evaluate the safety and tolerability of Cetuximab in combination with standard chemotherapy such as FOLFOX or FOLFIRI as first-line therapy of patients with KRAS wild-type metastatic colorectal cancer.
Secondary Objective:
- To evaluate the efficacy of Cetuximab in combination with standard chemotherapy as first-line therapy of patients with KRAS wild-type metastatic colorectal cancer.
研究类型
注册 (实际的)
联系人和位置
学习地点
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Delhi、印度、110055
- Nothern Railway Central Hospital
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Delhi、印度、110076
- Indraprastha Apollo Hospital
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Delhi、印度、110092
- Shanti Mukand Hospital
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Delhi、印度、110096
- Dharamshila Cancer Hospital & Research Centre
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Andhra Pradesh
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Hyderabad、Andhra Pradesh、印度、500034
- Indo- American Cancer Institute & Research Centre
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Hyderabad、Andhra Pradesh、印度、500063
- NVS Ramakrishna's Clinic
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Secunderabad、Andhra Pradesh、印度、500025
- Dr. Nikhil's Clinic
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Secunderabad、Andhra Pradesh、印度、500025
- Nikhil Gharyalpatil's Clinic
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Andrapradesh
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Hyderabad、Andrapradesh、印度、500001
- Ravi Kumar's Clinic
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Hyderabad、Andrapradesh、印度、500008
- Ambaa Hospitals
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Hyderabad、Andrapradesh、印度、500059
- Swarna Sai Hospital
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Bangalore
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Mangalore、Bangalore、印度、575 001
- Manipal Centre For Clinical Research
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Calicut
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Kerala、Calicut、印度、673016
- Medical College Calicut
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Gujarat
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Ahmedabad、Gujarat、印度、380009
- Hemato Oncology Clinic
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Karnataka
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Hubli、Karnataka、印度、580020
- Kattimani Oncology Clinic
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Kashmir
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Srinagar、Kashmir、印度、190001
- SKIMS
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Srinagar、Kashmir、印度、190010
- S. K. I. M. S.
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Madhya Pradesh
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Bhopal、Madhya Pradesh、印度、462001
- Dr. T. P. Sahoo's Clinic
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Maharashtra
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Mumbai、Maharashtra、印度、400014
- BND Onco Centre
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Mumbai、Maharashtra、印度、400071
- Joy Hospital
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Pune、Maharashtra、印度、411001
- Ruby Hall Clinic
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Mizoram
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Aizwal、Mizoram、印度、796 009
- Grace Nursing Home
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Mumbai
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Bandra、Mumbai、印度、400050
- Lilavati Hospital
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Mahim、Mumbai、印度、400016
- S.L.Raheja Hospital
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New Delhi
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Delhi、New Delhi、印度、110044
- Apollo Cancer Institute
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Delhi、New Delhi、印度、110085
- Rajiv Gandhi Cancer Institute & Research
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Punjab
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Amritsar、Punjab、印度、143004
- Fortis Escorts Hospital
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Chandigarh、Punjab、印度、160101
- Dr. Rajeev Bedi's Clinic
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Ludhiana、Punjab、印度、141001
- D.M.C Hospital
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Mohali、Punjab、印度、160071
- IVY Hospital
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Rajasthan
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Jaipur、Rajasthan、印度、302004
- SMS Hospital
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Jaipur、Rajasthan、印度、302004
- Cancer Clinic
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Jaipur、Rajasthan、印度、302006
- Bhagwan Mahaveer Cancer Hospital
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Jaipur、Rajasthan、印度、302030
- Bhagwan Mahaveer Cancer Hospital & Research Centre
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Jodhpur、Rajasthan、印度、3420003
- Vyas Cancer Care
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Tamilnadu
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Trivandrum、Tamilnadu、印度、695011
- TC 14/ 764 Sreemangalam
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Uttar Pradesh
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Ghaziabad、Uttar Pradesh、印度、201014
- Shati Gopal Hospital
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Lucknow、Uttar Pradesh、印度、226007
- Annapurna Medical and Cancer Relief Society
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West Bengal
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Kolkata、West Bengal、印度、700026
- Chittaranjan National Cancer Institute
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Kolkata、West Bengal、印度、700054
- Apollo Gleneagles Cancer Hospital
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参与标准
资格标准
适合学习的年龄
- 孩子
- 成人
- 年长者
接受健康志愿者
有资格学习的性别
取样方法
研究人群
描述
Inclusion Criteria:
- Subjects with histologically confirmed, adenocarcinoma of the colon or rectum (mCRC)
- Subjects with KRAS wild-type status of tumour tissue
- Chemotherapy naïve subjects
- Subject who have signed written informed consent (as per institutional protocol)
Exclusion Criteria:
- As per summary of product characteristics of cetuximab
学习计划
研究是如何设计的？
设计细节
研究衡量的是什么？
主要结果指标
结果测量 |
大体时间 |
|---|---|
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Safety and tolerability evaluated based on the incidence and severity of AEs.
大体时间：From baseline to follow-up visit for any ongoing AEs
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From baseline to follow-up visit for any ongoing AEs
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次要结果测量
结果测量 |
措施说明 |
大体时间 |
|---|---|---|
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Response rate
大体时间：Baseline to End-of-Study Visit
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Disease Control Rate (DCR), Progression Free Survival (PFS)and Overall Survival (OS)
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Baseline to End-of-Study Visit
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合作者和调查者
研究记录日期
研究主要日期
学习开始 (实际的)
初级完成 (实际的)
研究完成 (实际的)
研究注册日期
首次提交
首先提交符合 QC 标准的
首次发布 (估计)
研究记录更新
最后更新发布 (实际的)
上次提交的符合 QC 标准的更新
最后验证
更多信息
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