ACTRN12613000695707已完成2 期
TROG 07.04 A Phase I/II Study of Cetuximab, Carboplatin and Radiotherapy for patients with locally advanced head and neck squamous cell carcinoma
Trans Tasman Radiation Oncology Group0 个研究点目标入组 60 人开始时间: 2013年6月25日最近更新:
适应症
试验速览
- 阶段
- 2 期
- 状态
- 已完成
- 发起方
- 入组人数
- 60
研究概览
简要总结
暂无简介。
研究设计
- 研究类型
- Interventional
- 分配方式
- Non-randomised trial
- 主要目的
- Treatment
- 盲法
- Open (masking not used)
入排标准
- 年龄范围
- 18 Years 至 o limit（—）
- 性别
- All
入选标准
- •1. Previously untreated Squamous Cell Carcinoma (SCC) of the oropharynx, larynx or hypopharynx.
- •2. Stage III or IV, excluding T1N1, and metastatic disease (to be confirmed by a chest CT, and abdominal CT or ultrasound scan if patients with abnormal liver function tests or a bone scan or Flurodeoxyglucose Positron Emission Tomography (FDG-PET) if patients with bone pain).
- •3. Histologically or cytologically confirmed Head and Neck SCC
- •4. Disease must be considered potentially curable by chemoradiation
- •5. Patients medically unfit for cisplatin chemotherapy due to one or more of the following reasons:
- •- Clinically significant sensori-neural hearing impairment (audiometric abnormalities without corresponding clinical deafness will not be regarded as a contraindication to cisplatin)
- •- Severe tinnitus
- •- Renal impairment (Glomerular Filtration Rate (GFR) < 60ml/min)
- •- Peripheral neuropathy > grade 2
- •- Inability to tolerate intravenous hydration eg due to cardiac disease
- •- Co-morbidities (based on clinical judgement by the investigator) associated with Eastern Cooperative Oncology Group Performance Status (ECOG PS) 2 that in the view of the investigator would preclude the safe administration of cisplatin
- •6. Performance status ECOG 0, 1 or 2.
- •7. Adequate haematological, renal and hepatic functions as defined by:
- •- Absolute neutrophil count (Absolute Neutrophil Count (ANC), segmented cells (segs) + bands)>= 1.5 x 109/L
- •- Platelet count >= 100 x 109/L
- •- Total bilirubin <= 1.5 x upper normal limit
- •- Alanine aminotransferase <= 2.5 x upper normal limit
- •- Calculated creatinine clearance > 40ml/min (Cockcroft-Gault formula).
- •- If calculated creatinine clearance < 50 ml/min, glomerular filtration rate to be measured with Diethylene triamine pentaacetic acid (DTPA) or Ethylenediaminetetraacetic acid (EDTA) scan. If < 40 ml/min not eligible.
- •8. Age >18 years
- •9. Signed written consent
- •10. Suitable for follow-up for 4 years in the view of the investigator
排除标准
- •1. Distant metastases, i.e., any metastatic disease below the clavicles. Patients with lung nodules >10mm will be excluded unless non-malignancy aetiology is established. Patients with lesions 5-10mm can be included if a flurodeoxyglucose positron emission tomography (FDG-PET) scan is negative and the investigator considers on clinical grounds that metastasis is unlikely. Patients with lesions < 5mm can be included if the investigator considers on clinical grounds that metastases are unlikely. Patients with multiple lung nodules should not be included unless there is a strong case that these do not represent metastases, e.g., stable on imaging for over 12 months, non-malignant aetiology apparent. The level of clinical suspicion may be influenced by clinical stage, e.g., N3 disease, low neck nodes. In general if there is any doubt patients should be excluded.
- •2. Previous radical radiotherapy (RT) to the head & neck region, excluding superficial RT for a non-melanomatous skin cancer.
- •3. Patients with 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.
- •4. Significant intercurrent illness that will interfere with the chemotherapy or radiation therapy such as Humman Immunodeficiency virus (HIV) infection, cardiac failure, pulmonary compromise, active infection
- •5. Any history of myocardial infarction, ventricular arrhythmias, or unstable angina within the last 6 months
- •6. Pregnant or lactating women.
- •7. Weight loss greater than 20 % of usual body weight in the 3 months preceding trial entry
- •8. High risk for poor compliance with therapy or follow up as assessed by the investigator
- •9. Prior radiation to greater than 30% of the bone marrow
- •10. Prior systemic chemotherapy for cancer
- •11. Refusal by male or female patients, to use appropriate contraception during the study and for 3 months afterwards
- •12. Any condition or circumstance which might prevent the patient being able to give valid informed consent, or from completing participation in the study
研究者
相似试验
进行中（未招募）
不适用
A Stratified Phase II Study of Cetuximab (ErbituxTM) for the Treatment of Recurrent Glioblastoma Multiforme / Estudio de fase II estratificado de cetuximab para el tratamiento del glioblastoma multiforme recidivante - Cetuximab for recurrent GBMpatients with a recurrent glioblastoma multiforme following preceding surgery, radiation therapy and chemotherapyEUCTR2005-000459-14-ESOncologisch Centrum, Academisch Ziekenhuis Vrije Universiteit Brussel54
已完成
2 期
Phase II study of cetuximab rechallenge in the third-line therapy in patients with KRAS wild-type metastatic colorectal cancerJPRN-UMIN000010638Japan Clinical Cancer Research Organization35
进行中（未招募）
不适用
Phase II study of cetuximab in combination with cisplatin-docetaxel in the first-line treatment of patients with advanced non-small cell lung cancer (NSCLC): a biomarker-based assessment of activity. - NDon small cell lung cancerMedDRA version: 9.1Level: LLTClassification code 10001183MedDRA version: 9.1Level: LLTClassification code 10025038EUCTR2008-008387-27-ITGRUPPO ONCOLOGICO ITALIANO DI RICERCA
招募中
1 期
Phase 1/2 study of cetuximab plus capecitabine in elderly patients with kras-wild type mCRC who have no prior chemotherapyunresectable metastatic colorectal cancerJPRN-UMIN000004579Department of medical oncology, Cancer institute hospital, in Japan41
进行中（未招募）
1 期
Randomised phase II study with cetuximab (Erbitux®) in combination with 5-FU and cisplatin or carboplatin versus CETuximab (Erbitux®) in combination with paclitaxel and carboplatin for treatment of patients with relapsed or METastatic squamous cell carcinoma of the head and neck - CETMETPatients with metastatic or recurrent squamous cell carcinoma of the head and neck, not suitable for local treatmentMedDRA version: 19.0Level: PTClassification code 10067821Term: Head and neck cancerSystem Organ Class: 10029104 - Neoplasms benign, malignant and unspecified (incl cysts and polyps)EUCTR2010-022924-57-DKRadiumhemmet, Karolinska University Hospital, Stockholm, Sweden120