NCT01220063已完成2 期
CLINICAL MULTICENTER STUDY OF PHASE II AND RADIOBIOLOGY ASSESSING Hypofractionated Stereotactic Radiotherapy With Irinotecan (Campto) IN THE TREATMENT OF LIVER METASTASIS AND / OR PULMONARY, Unoperated or Recurrent After Surgery of a Colorectal Cancer
Institut Cancerologie de l'Ouest6 个研究点 分布在 1 个国家目标入组 48 人开始时间: 2007年10月19日最近更新:
适应症
干预措施
相关药物
试验速览
- 阶段
- 2 期
- 状态
- 已完成
- 发起方
- 入组人数
- 48
- 试验地点
- 6
- 主要终点
- tumor response accoording to recist criteria
研究概览
简要总结
The purpose of this study is to study stereotactic radiotherapy with a dose of 40 Gy in 4 fractions over 2 weeks with concomitant 40 mg/m2 of irinotecan (1st and 3rd irradiation session).
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
- •Age > or = 18 years
- •Social Insurance
- •Performance Index <2
- •Life expectancy> 6 months
- •adenocarcinoma colorectal (histologically proven)
- •Metastases (inoperable or recurrent after surgery),
- •hepatic localization and / or lung (up to 3 if one organ metastasis or 3 in total if the two bodies are metastatic). The largest diameter of the metastasis will < ou = 6cm for the liver, < or = 6 cm for the lung. If multiple metastases, the sum of their maximum diameter is 6cm < ou = the liver, < ou = 6 cm for the lung.
- •Lesion (s) measurable (s) and evaluable (s)
- •CT less than 3 weeks
- •Patients must have received at least one prior chemotherapy regimen containing 5FU
- •Patients may have received one or more lines of chemotherapy including irinotecan.
- •bilirubin <1.5 x ULN
- •AST and ALT <5x ULN
- •neutrophils> 1.5x109 / L, platelets> 100x109 / L, hemoglobin> 9 g / dL
- •TP, TCA Normal (only for patients treated with a permanent implant)
- •Informed consent signed.
排除标准
- •contraindication to the administration of irinotecan.
- •History of radiotherapy in the thoraco-abdominal-cons indicating further irradiation.
- •History of other invasive cancer treated in a period of less than 5 years (basal cell carcinoma and non-invasive cervical excepted)
- •Metastatic disease diffuse or more than three metastases in the liver and / or lung during the natural history of disease (excluding any patient is having a complete radiological response on several metastases although 1-3 residual after treatment ( s) medical (at)).
- •Location (s) tumor (s) = CTV to less than 12 mm laterally or less than 15 mm in the cranio-caudal, stomach, small intestine, esophagus, trachea, bronchi of right and left pulmonary arteries and right and left.
- •Pregnancy or breastfeeding.
- •Lack of means or refusal to use effective contraception for men or women of childbearing age.
- •Any other concomitant experimental treatment.
- •Any other concurrent anticancer therapy, immunotherapy or hormonal therapy.
- •Monitoring impossible because of psychological, sociological or because of geographical distance.
研究组 & 干预措施
Radiation + Irinotecan
Other
Irinotecan will be administered :
- 40 mg/m² in serum physiologique during 30 to 90 min at D1 and D8 of radiotherapy
Radiotherapy (RSHF) will be administered :
- at D1, D3, D8 and D10
- 48 Gy, 12 Gy by fractions twice a week
干预措施: Radiation (Radiation)
Radiation + Irinotecan
Other
Irinotecan will be administered :
- 40 mg/m² in serum physiologique during 30 to 90 min at D1 and D8 of radiotherapy
Radiotherapy (RSHF) will be administered :
- at D1, D3, D8 and D10
- 48 Gy, 12 Gy by fractions twice a week
干预措施: Irinotecan (Drug)
结局指标
主要结局
tumor response accoording to recist criteria
时间窗: 5 years
次要结局
未报告次要终点
研究者
研究点 (6)
Loading locations...
相似试验
已完成
2 期
Stereotactic Radiotherapy Plus Temozolomide for Refractory Brain MetastasesBrain MetastasesNCT02654106Chinese Academy of Medical Sciences65
招募中
1 期
Stereotactic Radiosurgery Dose Escalation for Brain MetastasesBrain MetastasesNCT02390518University of Utah86
进行中（未招募）
1 期
Study of Stereotactic Radiosurgery With Olaparib Followed by Durvalumab and Physician's Choice Systemic Therapy in Subjects With Breast Cancer Brain MetastasesBrain Metastases, AdultBreast CancerNCT04711824Colette Shen41
Unknown
2 期
Adjuvant Stereotactic Fractionated Radiotherapy to the Resection Cavity in Recurrent GlioblastomaGlioblastomaNCT02715297Technical University of Munich162
已完成
1 期
Phase I and II Study Of Stereotactic Body Radiotherapy in Medically Unresectable Patients With Stage 1 NSCLCNon-small Cell Lung CancerNCT00246181Jill Deluca117