EUCTR2015-001740-11-GB进行中（未招募）1 期
A randomised Phase II/III trial to study radiotherapy dose escalation in patients with oesophageal cancer treated with definitive chemo-radiation with an embedded Phase II trial for patients with a poor early response using positron emission tomography (PET) - SCOPE 2
Velindre NHS Trust0 个研究点目标入组 0 人开始时间: 2017年4月10日最近更新:
适应症
试验速览
- 阶段
- 1 期
- 状态
- 进行中（未招募）
- 发起方
研究概览
简要总结
暂无简介。
研究设计
- 研究类型
- Interventional clinical trial of medicinal product
入排标准
- 性别
- All
入选标准
- •1.17 years of age or older.
- •2.Have been selected to receive potentially curative definitive chemoradiotherapy by a specialist Upper GI MDT.
- •3.Histologically confirmed adenocarcinoma, undifferentiated cancer or squamous cell carcinoma.
- •4.Tumours of the cervical, thoracic oesophagus, or gastro-oesophageal junction (GOJ) with proximal extent of disease no more proximal than 15cm aboral and distal extent of primary tumour no more than 2 cm beyond the GOJ.
- •5. Tumours staged with spiral CT scan, PET-CT with/without endoscopic ultrasound (EUS), to be T1-4, N-/+ (provided total tumour length including nodes is =10). To be eligible for PET randomisation, the PET-CT must be within 4 weeks of start date of treatment.
- •6. Total contiguous disease length =10cm defined by CT, EUS and/or PET. This includes =8cm primary tumour plus nodes within 2cm.
- •7. WHO performance status 0 or 1.
- •8. Adequate haematological, renal, respiratory, cardiac and hepatic function, and are fit to receive all protocol treatment.
- •9. Patients with reproductive potential (male or female), who are sexually active during the duration of the trial, should be prepared to use a highly effective method of contraception preferably with low user dependency for at least six months after the last dose of chemoradiotherapy.
- •10. Patients who have provided written informed consent prior to randomisation.
- •Additional inclusion criteria for patient eligibility for PET randomisation:
- •11.Baseline SUVmax = 5.
- •12.PET scan 14 days after start of chemo (-2/+3 days from this date is acceptable)
- •13.Not responding to early cis/cape chemotherapy (<35% reduction in SUVmax)
- •14.For diabetics, fasting Blood glucose =12 mmol/L.
- •Are the trial subjects under 18? yes
- •Number of subjects for this age range: 0
- •F.1.2 Adults (18-64 years) yes
- •F.1.2.1 Number of subjects for this age range 292
- •F.1.3 Elderly (>=65 years) yes
- •F.1.3.1 Number of subjects for this age range 292
排除标准
- •1. Patients who have had previous treatment for invasive oesophageal carcinoma or gastro-oesophageal junction carcinoma
- •2. Patients with metastatic disease
- •3. Patients with other active malignancy or past malignancy in remission for less than 3 years except patients that have been curatively treated from the following conditions; basal cell carcinoma, Carcinoma-in-situ breast and carcinoma-in-situ cervix
- •4. Patients with >2cm mucosal extension of tumour into the stomach or where the superior extent is proximal to 15 cm ab oral.
- •5. Patients with unstable angina or uncontrolled hypertension or cardiac failure or other clinically significant cardiac disease.
- •6. Patients who need continued treatment with a contraindicated concomitant medication or therapy.
- •7. Patients with known dihydropyrimidine dehydrogenase (DPD) deficiency.
- •8. Patients with hearing impairment or sensory-motor neuropathy of WHO grade =2.
- •9. Known hypersensitivity to IMPs.
- •10. Women who are pregnant or breastfeeding..
- •11. Oesophageal stent (Patients requiring a PEG/RIG/feeding jejunostomy for nutritional purposes are eligible).
- •12. Any other situation, which in the opinion of the local PI, makes the patient an unsuitable candidate for this trial (eg with profusely bleeding tumours where the PI has concerns about randomisation to paclitaxel/carboplatin arm where there is risk of aggravation of bleeding due to higher risk of thrombocytopenia)
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