Panitumumab in Combination With Radiotherapy in Patients With Locally Advanced RAS Wildtype Rectal Cancer (Clinical Stages II and III) (NEO-RIT)
2016年1月12日 更新者:WiSP Wissenschaftlicher Service Pharma GmbH
NEO-RIT - Panitumumab in Combination With Radiotherapy in Patients With Locally Advanced RAS Wildtype Rectal Cancer (Clinical Stages II and III)
The objective of this trial is to obtain evidence that, in patients with RAS wildtype tumors, a chemotherapy-free combined modality treatment with panitumumab is clearly superior to radiotherapy alone and achieves a pCR rate comparable to that after radiochemotherapy including two-drug combinations while reducing the toxicity compared to these two-drug regimens.
研究概览
研究类型
介入性
注册 (实际的)
59
阶段
- 阶段2
联系人和位置
本节提供了进行研究的人员的详细联系信息,以及有关进行该研究的地点的信息。
学习地点
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-
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Esslingen、德国、73780
- Klinikum Esslingen Klinik für Onkologie, Gastroenterologie und Allgemeine Innere Medizin
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Frankfurt/Main、德国、60590
- Klinik für Strahlentherapie und Onkologie, Universitätsklinikum Frankfurt am Main
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Heilbronn、德国、74078
- SLK-Kliniken Heilbronn GmbH Medizinische Klinik III
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Mannheim、德国、68167
- Tagestherapiezentrum am ITM & III. Medizinische Klinik, Universitätsmedizin Mannheim
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Recklinghausen、德国、45659
- Prosper Hospital Medizinische Klinik I
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参与标准
研究人员寻找符合特定描述的人,称为资格标准。这些标准的一些例子是一个人的一般健康状况或先前的治疗。
资格标准
适合学习的年龄
18年 及以上 (成人、年长者)
接受健康志愿者
不
有资格学习的性别
全部
描述
Inclusion Criteria:
- Histologically confirmed diagnosis of locally advanced rectal cancer (stage II or III) localised 0 - 12 cm ab ano as measured by rigid rectoscopy (i.e. lower and middle third of the rectum)
- Staging requirements: trans-rectal endoscopic ultrasound (EUS) and magnetic resonance imaging (MRI)
- Sufficient representative sample material for RAS analysis
Wild-type RAS (determined by an accredited local laboratory, if not available by pathology of Mannheim university)
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)
- Informed consent of the patient
- Aged at least 18 years
- WHO Performance Status 0-2
- Life expectancy of al least 12 weeks
Adequate haematological, hepatic, renal and metabolic function parameters:
- Leukocytes > 3000/mm³
- ANC ≥ 1500/mm³
- Platelets ≥ 100,000/mm³
- Hb > 9 g/dl
- Creatinine clearance ≥ 50 ml/min and serum creatinine ≤ 1.5 x upper limit of normal
- Bilirubin ≤ 1.5 x upper limit of normal
- GOT-GPT ≤ 2.5 x upper limit of normal
- AP ≤ 5 x upper limit of normal
- Magnesium ≥ lower limit of normal
- Calcium ≥ lower limit of normal
Exclusion Criteria:
- Lower border of the tumor localised more than 12 cm ab ano as measured by rigid rectoscopy
- Distant metastases (to be excluded by CT scan of the thorax and abdomen)
- cT4 tumor (as determined by MRI and/or endorectal ultrasound)
- Risk of tumor involvement of the circumferential resection margin, according to the MRI assessment
- Sphincter sparing is the major reason for choosing the neoadjuvant treatment approach
- Prior antineoplastic therapy for rectal cancer
- Prior radiotherapy of the pelvic region
- Major surgery within the last 4 weeks prior to inclusion
- 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
- Prior 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 study medication
学习计划
本节提供研究计划的详细信息,包括研究的设计方式和研究的衡量标准。
研究是如何设计的?
设计细节
- 主要用途:治疗
- 分配:不适用
- 介入模型:单组作业
- 屏蔽:无(打开标签)
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 |
---|---|---|
Rate of pathological complete remissions
大体时间:15 weeks (average) after start of treatment (at surgery)
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The rate of pathological complete remissions is determined after tumor resection following neoadjuvant treatment.
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15 weeks (average) after start of treatment (at surgery)
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次要结果测量
结果测量 |
大体时间 |
---|---|
Toxicity according to NCI CTCAE
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Frequency of surgical morbidity and complications
大体时间:Within four weeks after surgery
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Within four weeks after surgery
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pTNM findings in relation to initial cTNM staging
大体时间:At surgery
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At surgery
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Regression grading according to Dworak
大体时间:At surgery
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At surgery
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Clinical response rates (CR/PR/SD/PD) after neoadjuvant treatment
大体时间:Before surgery
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Before surgery
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Correlative biomarker analyses
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合作者和调查者
在这里您可以找到参与这项研究的人员和组织。
调查人员
- 首席研究员:Ralf Hofheinz, Prof. Dr. med.、Tagestherapiezentrum am ITM & III. Medizinische Klinik, Universitätsmedizin Mannheim
研究记录日期
这些日期跟踪向 ClinicalTrials.gov 提交研究记录和摘要结果的进度。研究记录和报告的结果由国家医学图书馆 (NLM) 审查,以确保它们在发布到公共网站之前符合特定的质量控制标准。
研究主要日期
学习开始
2010年12月1日
初级完成 (实际的)
2016年1月1日
研究完成 (预期的)
2016年7月1日
研究注册日期
首次提交
2010年12月1日
首先提交符合 QC 标准的
2010年12月8日
首次发布 (估计)
2010年12月9日
研究记录更新
最后更新发布 (估计)
2016年1月13日
上次提交的符合 QC 标准的更新
2016年1月12日
最后验证
2016年1月1日
更多信息
此信息直接从 clinicaltrials.gov 网站检索,没有任何更改。如果您有任何更改、删除或更新研究详细信息的请求,请联系 register@clinicaltrials.gov. clinicaltrials.gov 上实施更改,我们的网站上也会自动更新.