EUCTR2006-000811-12-GB进行中（未招募）1 期
A Randomised Phase II/III trial of peri-operative Chemotherapy with or without Bevacizumab in Operable Oesophagogastric Adenocarcinoma and A Feasibility Study Evaluating Lapatinib in HER-2 Positive Oesophagogastric Adenocarcinoma and (in selected centres) MRI and FDG-PET/CT Sub-studies - ST03
Medical Research Council Clinical Trials Unit0 个研究点目标入组 1,100 人开始时间: 2007年1月7日最近更新:
适应症
相关药物
试验速览
- 阶段
- 1 期
- 状态
- 进行中（未招募）
- 发起方
- 入组人数
- 1,100
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. a) Siewert type III OGJ or Gastric Adenocarcinomas (using gastric cancer staging system)
- •Tumours should be Stage Ib (T1 N1, T2a/b N0), II, III or stage IV (T4 N1 or N2) with no evidence of distant metastases (M0) where the surgeon believes that an R0 resection can be achieved by excision of a contiguous structure.
- •Patients with linitis plastica should not be randomised.
- •b) Lower Oesophageal or Siewert type I/II OGJ Adenocarcinomas (using oesophageal cancer staging system)
- •Tumours should be Stage II to Stage IVa (T1 N1, T2 N1, T3 N0-1, but not T2N0). T4 (N0 or N1) tumours are also eligible providing that they involve only the crura OR invade only the mediastinal pleura, where the surgeon believes that an R0 resection can be achieved by excision of a contiguous structure.
- •Patients with nodal disease affecting the origin of the left gastric and splenic artery or coeliac axis (hitherto staged as M1a) are also eligible.
- •2. All patients should have a CT of chest and abdomen (pelvis is optional) prior to study entry. Patients with gastric and Siewert type II and III OGJ adenocarcinomas should also have a laparoscopy prior to study entry. Endoscopic ultrasound (EUS) should be performed for all lower oesophageal and OGJ adenocarcinomas and according to local practice for other tumours.
- •3. WHO performance status of 0 or 1.
- •4. Adequate respiratory function: FEV1 greater than 1.5 litres (mandatory for all lower oesophageal and junctional tumours only)
- •5. Adequate cardiac ejection fraction greater than or equal to 50% for ECHO or greater than or equal to LLN for MUGA, BP less than or equal to 140/90mmHg.
- •6. Adequate bone marrow, Liver and renal function
- •7. 24 hr Urine collection for protein uria < 1g
- •8. Adequate coagulation profile
- •9. Patient fit to receive protocol treatment
- •10. Patients aged over 18 years
- •Are the trial subjects under 18? no
- •Number of subjects for this age range:
- •F.1.2 Adults (18-64 years) yes
- •F.1.2.1 Number of subjects for this age range 500
- •F.1.3 Elderly (>=65 years) yes
- •F.1.3.1 Number of subjects for this age range 500
排除标准
- •1. Cereborvascular disease
- •2. Cardiovascular Diseses including:
- •-myocardial Infarction (less than 1 year prior to randomisation)
- •- uncontrolled hypertension (BP>140/90mmHg)
- •- angina requiring nitrate therapy within 1 year prior to randomisation
- •- New York Heart Association Grade II or greater
- •- Serious cardiac arrhythmia requiring medication
- •3. Major Surgery/Trauma or biopsy within 28 days prior to randomisation
- •4. Serious non-healing wound, ulcer or bone fracture
- •5. Evidence of bleeding diathesis or coagulopathy
- •6. Recent history of any gastric inflammatory condition
- •7. Patient's with severe tinnitus
- •8. Patient's who have received chemotherapy or radiotherapy treatment previously
- •9. Lack of physical intergrity of the upper GI tract.
- •10. Positive serology for HIV, Hep C or active Hep B.
- •11. Patients who have previously received anthracycline treatment
- •12. known peripheral neuropathy (grade 1 and greater).
- •13. DPD deficiency
- •14. Allergy to chinese hamster ovary cell proteins or other recombinant human or humanized antibodies or to any exicpients of bevacizumab formulation, platinum compounds or to any other components of the study drugs.
- •15. Patients with oesophageal or gastric stent (metal or biodegradable) in situ.
- •16. Patients with a history of interstitial lung disease or radiological evidence of lung fibrosis.
研究者
相似试验
招募中
4 期
Prospective-randomized trial on the postoperative outcome after MPFL reconstruction with autologous tendon graft vs. artificial grafts (FiberTape)M22.0Recurrent dislocation of patellaDRKS00015654niversitätsklinikum Hamburg-Eppendorf90
招募中
3 期
on-randimized confirmatory trial of postoperative concurrent chemoradiotherapy (CCRT) using IMRT for patients with high-risk uterine cervical cancer (JCOG1402, PopCC IMRT-CCRT)Postoperative uterine cervical cancer patients with high-risk prognostic factorsJPRN-UMIN000027017Japan Clinical Oncology Group (JCOG)220
已完成
不适用
Evaluation of safety and efficacy of perioperative administration of TJ-100 in patients with postoperative functional aberration of the gastrointestinal tract due to surgery for colon cancercolon cancerJPRN-UMIN000032697Sapporo Medical University200
进行中（未招募）
1 期
Randomized trial evaluating the addition of nivolumab to cisplatin-radiotherapy combination for treatment of cancers of the head and neckCTIS2024-513206-65-00Groupe Oncologie Radiotherapie Tete Cou674
进行中（未招募）
1 期
Randomized trial evaluating the addition of nivolumab to cisplatin-radiotherapy combination for treatment of cancers of the head and neckSquamous cell carcinoma treated by primary surgeryStage III, stage IV (American Joint Committee on Cancer 7th edition)Oral cavity, oropharynx, hypopharynx or larynxMedDRA version: 21.0Level: PTClassification code 10060121Term: Squamous cell carcinoma of head and neckSystem Organ Class: 10029104 - Neoplasms benign, malignant and unspecified (incl cysts and polyps)EUCTR2017-004936-13-PLGORTEC680