Phase I-II on Radiochemotherapy Combined With Panitumumab in the Treatment of Localised Epidermoid Carcinoma of the Anus
试验速览
- 阶段
- 1 期
- 状态
- 已完成
- 发起方
- 入组人数
- 45
- 试验地点
- 14
- 主要终点
- Percentage of Patients With Complete Response to Treatment
研究概览
简要总结
Treatment is based on radiochemotherapy for locally advanced tumours. The objective of treatment is to provide a cure without resorting to abdominoperineal amputation, while preserving sphincter function.
The prognosis is mainly related to tumour size and lymph node invasion. The large majority of patients do not show any spread remote from the tumour at the time of diagnosis (2).
Recurrences are mainly of a local/regional nature and require abdominoperineal amputation. This type of intervention is not always possible or complete, which then gives rise to the particularly distressing risk of local progression, with survival at 3 years of approximately 30% (3).
It is therefore very important to achieve a complete and permanent tumour response from initial treatment with radiochemotherapy.
Furthermore, the use of an anti-EGFR antibody in combination with exclusive radiotherapy in ENT cancer was able to increase recurrence-free survival and overall survival in these patients. These data are in favour of the use of a combination of chemotherapy and anti-EGFR antibodies in epidermoid cancer of the anus.
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 proven epidermoid carcinoma of the anus
- •Locally advanced tumour without metastases
- •Stage T2>3 cm or T3 or T4, irrespective of N
- •Stage N1-N3 irrespective of T stage (T1 to T4)
- •General condition WHO 0-1
- •Life expectancy > 3 months
- •Signed informed consent form
- •Age > 18 years
- •Effective contraception in female and/or male patients having reached sexual maturity during treatment and up to 6 months after the end of treatment
- •CD4 > 400 / mm3
- •Measureable tumor on at least one of the following exams : MRI, endoscopic ultrasonography, clinical exam
排除标准
- •Presence of metastases
- •Previous anti-EGFR therapy
- •Stage T1N0 or T2 < 3 cm N0
- •History of pelvic radiotherapy
- •At least one of the following laboratory test results: Neutrophils < 1500 /mm3, platelets < 100 000 /mm3, Hb < 9 g/dl, leukocytes < 3000/mm3, blood bilirubin > 1.5 times the upper limit of the normal range, transaminase (ASAT and ALAT) > 2.5 times the upper limit of the normal range, creatinine clearance < 50 mL/min (Cockcroft's formula Appendix x), Mg2+ < the lower limit of the normal range, Ca2+ < the lower limit of the normal range
- •Significant coronary artery disease or myocardial infarction in the past year
- •Follow-up not possible due to psychological or geographic reasons
- •History of interstitial pneumonitis or pulmonary fibrosis
- •History of malignant disease in the past five years apart from basocellular skin carcinoma or in situ cervical carcinoma having received adequate treatment
- •Pregnant or breast-feeding women, women of child-bearing potential not having taken a pregnancy test.
研究组 & 干预措施
5Fu-mitomycine-panitumumab + radiotherapy
5 FU = 400 or 600 or 80 or 1000 mg depending of phase I results, days 1 to 4 weeks 1, 5 and 8 mitomicyne = 10 mg/m² day 1 week 1 and days 1, weeks 5 and 8 Panitumumab = 3 or 6 mg/kg (depending of phase I results) days 1, weeks: 1, 3, 5, 8 and 10
干预措施: radiochemotherapy (Drug)
5Fu-mitomycine-panitumumab + radiotherapy
5 FU = 400 or 600 or 80 or 1000 mg depending of phase I results, days 1 to 4 weeks 1, 5 and 8 mitomicyne = 10 mg/m² day 1 week 1 and days 1, weeks 5 and 8 Panitumumab = 3 or 6 mg/kg (depending of phase I results) days 1, weeks: 1, 3, 5, 8 and 10
干预措施: Panitumumab (Drug)
结局指标
主要结局
Percentage of Patients With Complete Response to Treatment
时间窗: 8 weeks evaluations after the end of the treatment by radiochemotherapy
Complete response was defined by the complete disappearance of the tumor on proctological examination and morphological examinations (MRI and/or echo-endoscopy) and the absence of secondary lesion appearance. The responses were validated by an independent committee: * In the event of a discrepancy between the investigator and the independent committee, the independent committee's response was used; * in case of uncertainty of the investigator on the response, the committee decided on the response in view of the clinical and morphological data; This endpoint was assessed 8 weeks after the end of treatment (week 15). A patient who died (regardless of cause) was considered a failure for the primary endpoint
次要结局
- Percentage of Patients With Complete Response to Treatment(16 weeks after the end of the treatement by radiotherapy)
- 3 Years Colostomy-free Survival (CFS)(At 3 years after inclusion)
- Recurrence-free Survival (RFS) at 3 Years(At 3 years after inclusion)
- Overall Survival (OS) at 12 Months(At 12 months after inclusion)