NCT01257360Unknown2 期
NEO-RIT - Panitumumab in Combination With Radiotherapy in Patients With Locally Advanced RAS Wildtype Rectal Cancer (Clinical Stages II and III)
WiSP Wissenschaftlicher Service Pharma GmbH10 个研究点 分布在 1 个国家目标入组 59 人开始时间: 2010年12月1日最近更新:
适应症
相关药物
试验速览
- 阶段
- 2 期
- 发起方
- 入组人数
- 59
- 试验地点
- 10
- 主要终点
- Rate of pathological complete remissions
研究概览
简要总结
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.
研究设计
- 研究类型
- Interventional
- 分配方式
- Na
- 干预模型
- Single Group
- 主要目的
- Treatment
- 盲法
- None
入排标准
- 年龄范围
- 18 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •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
排除标准
- •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
结局指标
主要结局
Rate of pathological complete remissions
时间窗: 15 weeks (average) after start of treatment (at surgery)
The rate of pathological complete remissions is determined after tumor resection following neoadjuvant treatment.
次要结局
- Clinical response rates (CR/PR/SD/PD) after neoadjuvant treatment(Before surgery)
- Correlative biomarker analyses
- Toxicity according to NCI CTCAE
- Frequency of surgical morbidity and complications(Within four weeks after surgery)
- pTNM findings in relation to initial cTNM staging(At surgery)
- Regression grading according to Dworak(At surgery)
研究者
研究点 (10)
Loading locations...
相似试验
已完成
2 期
Neoadjuvant Radiochemotherapy Combined With Panitumumab in Locally Advanced KRAS Wild-type Rectal CancerRectal CancerNCT01443377National Center for Tumor Diseases, Heidelberg48
已完成
2 期
CAPOX in KRAS Wild-Type Advanced Adenocarcinoma of the Small Bowel or Ampulla of VaterGastrointestinal CancerNCT01202409M.D. Anderson Cancer Center19
已完成
1 期
Panitumumab Chemoradiotherapy Chemotherapy for Squamous Cancer of the Head and NeckSquamous Cell Carcinoma of the Head and NeckNCT00513383Massachusetts General Hospital34
撤回
2 期
A Pilot Study to Evaluate the Efficacy and Safety of Neoadjuvant Chemoradiotherapy With Capecitabine, . . .Pancreatic CancerNCT01130701University of Massachusetts, Worcester
Unknown
2 期
Anti-angiogenetic Therapy With Radiotherapy for Pediatric NeuroblastomaNeuroblastomaNCT02615106Xinhua Hospital, Shanghai Jiao Tong University School of Medicine60