Comparison of Two Preemptive Treatment Strategies of Panitumumab Mediated Skin Toxicity and Assessment of QoL in Patient With Ras-wt Colorectal Cancer
Comparison of Two Preemptive Treatment Strategies of Panitumumab Mediated Skin Toxicity and Assessment of Quality of Life in Patients With Ras-wildtype Colorectal Cancer
80 - 90 % of the patients treated with anti-EGFR antibodies (panitumumab or cetuximab) experience skin toxicity, mostly acne like skin rash.
A standardized treatment of skin rash is neither established as standard arm for clinical trials nor as guideline for the treatment of skin toxicity in clinical practice. While an improvement of QoL has been demonstrated for panitumumab and cetuximab in comparison to best supportive care the data basis for patient related outcomes regarding skin toxicity deriving from randomized trials is still small.
Recent surveys among German oncologist revealed that physicians are reluctant to use oral antibiotics as preemptive treatment . Only 19 out of 110 oncologists stated that they are thinking about using preemptive treatment in patients with acne-like skin rash.
Thus, in the present trial two main questions will be addressed:
(i) Can preemptive treatment with oral doxycycline be replaced by a sequential skin treatment strategy (i.e. local treatment with erythromycin followed by doxycycline in case of inefficacy = development of acne) without compromising treatment efficacy of skin toxicity treatment? (ii) Comparison of general and skin related QoL between both treatment arms.
研究概览
研究类型
注册 (实际的)
阶段
- 阶段2
联系人和位置
学习地点
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Mannheim、德国、68167
- Universitätsklinikum Mannheim, III. Medizinische Klinik
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参与标准
资格标准
适合学习的年龄
接受健康志愿者
有资格学习的性别
描述
Inclusion Criteria:
Patients with wild-type RAS (KRAS and NRAS) status of metastatic colorectal cancer treatment with panitumumab according to label
- RAS wild-type tested in
- KRAS exon 2 (codons 12/13)
- KRAS exon 3 (codons 59/61)
- KRAS exon 4 (codons 117/146)
- NRAS exon 2 (codons 12/13)
- NRAS exon 3 (codons 59/61)
- NRAS exon 4 (codons 117/146)
- treatment with pre-emptive study medication shall begin the day before treatment start with panitumumab
- Willingness to cope with biweekly quality of life questionnaires
- Written Informed consent
- Aged at least 18 years
- ECOG Performance Status 0-2
- Life expectancy of at least 12 weeks
Adequate haematological, hepatic, renal and metabolic function parameters:
- Leukocytes > 3000/mm³
- ANC ≥ 1500/mm³
- Platelets ≥ 100,000/mm³
- Haemoglobin > 9 g/dl
- Serum creatinine ≤ 1.5 x ULN
- Bilirubin ≤ 1.5 x ULN
- GOT-GPT ≤ 2.5 x ULN (in case of liver metastases GOT / GPT ≤ 5 x ULN)
- AP ≤ 5 x ULN
- Magnesium, Calcium and potassium within normal ranges (may be substituted before study entry)
Exclusion criteria:
- Subject pregnant or breast feeding, or planning to become pregnant within 6 months after the end of treatment.
- Subject (male or female) is not willing to use highly effective methods of contraception (per institutional standard) during treatment and for 6 months (male or female) after the end of treatment (adequate: oral contraceptives, intrauterine device or barrier method in conjunction with spermicidal jelly).
- Serious concurrent diseases
- On-treatment participation in a clinical study in the period 30 days prior to inclusion
- Clinically significant cardiovascular disease in (incl. myocardial infarction, unstable angina, symptomatic congestive heart failure, serious uncontrolled cardiac arrhythmia) ≤ 1 year before enrolment.
- History of interstitial lung disease, e.g. pneumonitis or pulmonary fibrosis or evidence of interstitial lung disease on baseline chest CT scan.
- History of HIV infection.
- Other previous or concurrent malignancy (≤ 5 years prior to enrolment in study) except non-melanoma skin cancer or cervical carcinoma FIGO stage 0- 1 if the patient is continuously disease-free
- Known allergic reactions on panitumumab, doxycycline or erythromycin
- Previous treatment with anti-cancer agents directed against EGFR (e.g. cetuximab, panitumumab, erlotinib, gefitinib, lapatinib)
- Skin rash existing before or due to other reasons than panitumumab treatment
- Other dermatologic disease that may interfere with correct grading of panitumumab induced skin rash
- Parallel treatment with anti-tumor agents other than panitumumab
学习计划
研究是如何设计的?
设计细节
- 主要用途:预防
- 分配:随机化
- 介入模型:并行分配
- 屏蔽:无(打开标签)
武器和干预
参与者组/臂 |
干预/治疗 |
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实验性的:Erythromycin
Experimental Arm (ARM A) skin- treatment: erythromycin cream 2% daily at bedtime doxycycline 100mg b.i.d.if skin toxicity CTC° ≥2 skin moisturizer daily at morning, sunscreen before going outdoors for 8 weeks
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Comparison of efficacy of Arm A erythromycin cream 2% daily at bedtime (doxycycline 100mg b.i.d.if skin toxicity CTC° ≥2) and Arm B doxycycline 100mg b.i.d. in patients with Metastatic Colorectal cancer (Ras wild-type)being treated with panitumumab.
其他名称:
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有源比较器:Doxycyline
Standard Arm (ARM B) skin- treatment:doxycycline 100mg b.i.d.
skin moisturizer daily at morning, sunscreen before going outdoors for 8 weeks
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Comparison of efficacy of Arm A erythromycin cream 2% daily at bedtime (doxycycline 100mg b.i.d.if skin toxicity CTC° ≥2) and Arm B doxycycline 100mg b.i.d. in patients with Metastatic Colorectal cancer (Ras wild-type)being treated with panitumumab.
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研究衡量的是什么?
主要结果指标
结果测量 |
措施说明 |
大体时间 |
---|---|---|
Percentage of patients developing no skin toxicity ≥ grade 2
大体时间:8 weeks
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Percentage of patients developing no skin toxicity ≥ grade 2 at any time during their first 8-weeks of treatment with panitumumab.
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8 weeks
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次要结果测量
结果测量 |
措施说明 |
大体时间 |
---|---|---|
Quality of life
大体时间:8 weeks
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Quality of life will be assessed by standardized skin-related (DLQI) and global quality of life (EORTC QLQ C30. For correlation analyses between the different quality of life scores, the non-parametric test according to Spearman will preferably be applied. |
8 weeks
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Assess Skin toxicity
大体时间:8 weeks
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Assess different skin toxicity grading scales (i.e.
NCI CTC v. 4.0; WoMo score; MESTT)
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8 weeks
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Correlation between skin-related and global quality of life
大体时间:8 weeks
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Description of correlation between skin-related and global quality of life using EORTC-QLQ C30 and SF-36.
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8 weeks
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late skin toxicity
大体时间:from week 8 to 12
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Describe the development of late skin toxicity after 8 weeks
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from week 8 to 12
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Skin-toxicity related dose reductions of panitumumab
大体时间:8 weeks
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Rate of skin-toxicity induced dose reductions (including withdrawal) of panitumumab
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8 weeks
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合作者和调查者
调查人员
- 首席研究员:Melanie Kripp, Dr. med.、III. Medizinische Klinik, Universitätsmedizin Mannheim
出版物和有用的链接
有用的网址
研究记录日期
研究主要日期
学习开始
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 (估计)
上次提交的符合 QC 标准的更新
最后验证
更多信息
与本研究相关的术语
关键字
其他相关的 MeSH 术语
其他研究编号
- AIO-LQ-0110
- 2010-022938-85 (EudraCT编号)
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