EUCTR2010-019071-29-GB进行中（未招募）不适用
A Phase 3 Randomized Trial of Concurrent Cisplatin And Radiotherapy With or Without OncoVEXGM-CSF in Previously Untreated Patients with Locally Advanced Squamous Cell Carcinoma of the Head and Neck
试验速览
- 阶段
- 不适用
- 状态
- 进行中（未招募）
- 发起方
- BioVex, Inc.
- 入组人数
- 580
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. Male or female = 18 years.
- •2. ECOG Performance Status = 1.
- •3. Histological evidence (from the primary lesion and/or lymph nodes) of squamous cell carcinoma of the oral cavity, oropharynx, hypopharynx, or larynx.
- •4. Stage III or IV disease (T2N2-3M0, T3-4 N1-3 M0).
- •5. No evidence of distant metastases by CT or PET/CT scan.
- •6. Life expectancy = 4 months.
- •7. Neutrophil count = 2,000/mm^3.
- •8. Platelet count = 100,000/mm^3.
- •9. Hemoglobin = 10 g/dL.
- •10. Bilirubin = 1.5 times ULN s.
- •11. AST and ALT = 2.5 times ULN.
- •12. Alkaline phosphatase = 2.5 times ULN.
- •13. Creatinine clearance = 60 mL/min.
- •14. Female patients of child-bearing potential (i.e. not surgically sterile, or not having
- •spontaneous amenorrhea for at least 12 months) must agree to use an effective form of contraception during the treatment phase of the study.
- •15. Male patients must agree to use a condom with spermicide or their female partner must use an effective method of birth control.
- •16. Provide written informed consent in accordance with all applicable regulations and follow the study procedures. Patients must be capable of understanding the
- •investigational nature, potential risks and benefits of the study.
- •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
- •F.1.3 Elderly (>=65 years) yes
- •F.1.3.1 Number of subjects for this age range
排除标准
- •1. Prior treatment for locally advanced SCCHN (NO prior surgery for SCCHN except
- •nodal sampling or biopsy for study disease).
- •2. Patients with T1-2N1 or T1N2-3.
- •3. Pre-existing peripheral neuropathy = Grade 2 (motor or sensory).
- •4. Weight loss > 20% of body weight within 3 months of screening (unless purposeful).
- •5. Surgery = 28 days before randomization with the exception of feeding tube
- •placement, dental extractions, central venous catheter placement, biopsies and
- •nodal sampling.
- •6. Cancer of the nasopharynx, sinus, salivary gland or skin.
- •7. Previous radical RT to the head and neck region, excluding superficial RT for a nonmelanomatous skin cancer.
- •8. Prior cancers, except: those diagnosed > 5 years ago with no evidence of disease
- •recurrence and clinical expectation of recurrence of less than 5%; or successfully treated non-melanoma skin cancer; or carcinoma in situ of the cervix.
- •9. Significant intercurrent illness that will interfere with the chemotherapy or radiation
- •therapy such as HIV infection, cardiac failure, pulmonary compromise (chronic
- •obstructive pulmonary disease, pneumonia or respiratory decompensation) resulting
- •in hospitalization within 12 months of screening, or active infection.
- •10. Any significant cardiac disease (e.g., New York Heart Association (NYHA) Class 3 or 4; myocardial infarction within the past 6 months; unstable angina; coronary
- •angioplasty or coronary artery bypass graft (CABG) within the past 6 months; or
- •uncontrolled atrial or ventricular cardiac arrhythmias).
- •11. High risk for poor compliance with therapy or follow up as assessed by the
- •investigator.
- •12. Active herpes labialis, other lesions due to HSV1 or dermatoses involving or within 50 cm of the lesions to be injected; active HSV1 lesions must have resolved before OncoVEXGM-CSF is injected.
- •13. Prior systemic chemotherapy for any type of cancer.
- •14. Patients for whom radiation therapy is contraindicated.
- •15. Pregnant or breast-feeding female. Confirmation that women of child-bearing
- •potential are not pregnant. A negative serum ß- human chorionic gonadotropin (ß-
- •hCG) pregnancy test result must be obtained during the screening period.
- •16. Currently enrolled and receiving an investigational agent in a clinical research study or received an investigational agent for any reason within 4 weeks prior to screening.
- •17. Require intermittent or chronic treatment with an anti-herpetic drug (e.g., acyclovir), other than intermittent topical use.
研究者
相似试验
进行中（未招募）
不适用
Multicenter phase III randomized study of cisplatin and etoposide with or without bevacizumab as first-line treatment in extensive stage (ED) small cell lung cancer (SCLC) - NDEUCTR2007-007949-13-ITGRUPPO ONCOLOGICO ITALIANO DI RICERCA
进行中（未招募）
1 期
Randomized Phase II Trial of Three-weekly Cisplatinum and Pemetrexed versus Split-dose d1 and d8 Cisplatinum and Pemetrexed In Advanced and Inoperable Non-squamous Non-small-cell lung cancer (NSCLC)EUCTR2011-001963-37-DEniversitätsklinikum Essen
已完成
3 期
A phase III trial of postoperative cisplatin, interferon alpha-2b, and 5-FU combined with external radiation treatment versus 5-FU alone for patients with resected pancreatic adenocarcinomaMalignant neoplasm of pancreasCancerPancreatic cancerISRCTN62866759niversity of Heidelberg (Germany)110
已完成
2 期
A randomized phase II study comparing cisplatin + docetaxel with carboplatin + paclitaxel in patients with Stage III (N 2 positive) non-small-cell lung cancer who receive trimodality treatment consisting of chemoradiotherapy followed by surgery (OLCSG1601)previously untreated non-small-cell lung ccancer, stage III (N2 positive)JPRN-UMIN000024816Okayama Lung Cancer Study Group (OLCSG)80
已完成
2 期
Multicenter randomized phase II study of cisplatin+pemetrexed+bevacizmab followed by maintenance pemetrexied with or without bevacizmab in patients chemoterapy-naive advanced non-squamous non-small cell lung cancer with wild type EGFR(TORG1321)JPRN-UMIN000010681Thoracic Oncology Tesearch Group108