NCT00716391已完成3 期
Open Label Randomized, Multi-centre Phase III Trial of TPF Plus Concomitant Treatment With Cisplatin and Radiotherapy Versus Concomitant Cetuximab and Radiotherapy in Locally Advanced, Unresectable Head and Neck Cancer.
Grupo Español de Tratamiento de Tumores de Cabeza y Cuello55 个研究点 分布在 1 个国家目标入组 519 人开始时间: 2008年7月7日最近更新:
适应症
干预措施
试验速览
- 阶段
- 3 期
- 状态
- 已完成
- 入组人数
- 519
- 试验地点
- 55
- 主要终点
- Global survival
研究概览
简要总结
An Open Label Randomized, Multi-Centre Phase III Trial of TPF Chemotherapy Plus Concomitant Treatment With Cisplatin and Conventional Radiotherapy Versus TPF Chemotherapy Plus Concomitant Cetuximab and Conventional Radiotherapy in Locally Advanced, Unresectable Head and Neck Cancer.
详细描述
This study is being sponsored by a cooperative medical group.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Treatment
- 盲法
- None
入排标准
- 年龄范围
- 18 Years 至 70 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Before the beginning of protocol's specific procedures, the informed consent has to be obtained.
- •Locally advanced cancer of head and neck (oral cavity, oropharynx, larynx and hypopharynx) stage III-IV, without evidence of metastasis.
- •The tumor must be considered to be non-operable according to the criteria of the Northern California Oncology Group. The reason of non-surgical resection will be annotated in the CRF.
- •Criteria of non-surgical resection according to the NCOG:
- •3.1.Technically not resectable (includes: evidence of mediastinal dissemination; fixed tumor to the clavicle, base of the cranium or cervical vertebrae; affectation of the nasopharynx).
- •3.2.Medical criteria based on a low surgical curability. 3.3.Medical contraindication for the surgery.
- •Epidermoid carcinoma histologically demonstrated
- •Measurable disease according to the RECIST criteria .
- •Men or women with age between 18 and 70 years, both inclusive.
- •Functional condition index according to ECOG scale:0-1
- •Patients in medical conditions to be able to receive treatment with TPF induction followed by normofractionated radiotherapy with cetuximab or cisplatin.
- •Patients with adequate hematologic function: neutrophils superior or equal to 2 x 109, platelets superior or equal to 100 x 109, hemoglobin superior or equal to 10 g/dl.
- •Adequate hepatic function: bilirubin lower or equal to 1 x top normal Limit, GOT and GPT lower or equal to 2,5 Top Normal Limit , alkaline phosphatase < 5 Top Normal Limit.
- •Adequate renal function: creatinin <1,4 mg/dl (120 µmol/l); if the values are > 1,4 mg/dl, the clearance of creatinin will have to be > 60 ml/min (real or calculated for Cockcroft-Gault's method).
- •Calcium lower or equal to 1,25 x top normal limit.
- •Adequate nutritional condition: loss of weight <20% with relation to the theoretical weight and albumin superior or equal to 35 g/L.
- •Patients must be accessible for the treatment and the follow-up.
排除标准
- •Metastatic disease
- •Surgical treatment, previous radiotherapy and/or chemotherapy for the study disease.
- •Other tumor locations in head and neck that are not oral cavity, oropharynx, larynx, hypopharynx.
- •Other stages that are not III or IVM
- •Other previous and / or synchronic squamous carcinoma.
- •Diagnosis of another neoplasia in the last 5 years, excepting carcinoma in situ of uterine neck and/or a cutaneous carcinoma basocellular properly treated.
- •Active infection(at needs endovenous antibiotics), including active tuberculosis and diagnosed HIV.
- •Not controlled hypertension defined as arterial systolic tension superior or equal to 180 mm Hg and / or diastolic arterial tension superior or equal to 130 mm Hg baseline.
- •Pregnancy(absence must be confirmed with the test of beta-HCG) or period of lactation.
- •Immunity systemic treatment, chronic and concomitant, or hormonal treatment of the cancer.
- •Other antineoplastic concomitant treatments.
- •Coronary clinically significant arteriopathy or precedents of myocardial infarction in the last 12 months or high risk of not controlled arrhythmia or cardiac not controlled insufficiency.
- •Pulmonary obstructive chronic disease that had needed 3 or more hospitalizations in the last 12 months.
- •Active non controlled peptic ulcer.
- •Presence of a psychological or medical disease that could prevent to accomplish the study by the patient or to grant his/her signature in the informed consent form.
- •Known drugs abuse (with the exception of excessive consumption of alcohol)
- •Known allergic reaction to some of the components of the treatment of the study.
- •Previous treatment with monoclonal antibodies or other transduction of the sign inhibitors or treatment directed against the EGFR.
- •Any experimental treatment in 30 days before the entry in the study.
研究组 & 干预措施
Group A
Active Comparator
TPF plus concomitant treatment with cisplatin and conventional radiotherapy.
干预措施: TPF, radiotherapy and cisplatin. (Other)
Group B
Experimental
TPF plus concomitant treatment with cetuximab and conventional radiotherapy
干预措施: TPF, radiotherapy and cetuximab. (Other)
结局指标
主要结局
Global survival
时间窗: Up to 89 months
The time from the start of induction chemotherapy with TPF to death due to any cause or to the last check-up in the case of living patients
次要结局
- Time to loco-regional control of disease(Up to 89 months)
- Overall response rate (ORR)(Up to 89 months)
- Progression free-survival (PFS)(Up to 89 months)
- Satisfaction with treatment. Analysis of QoL in both treatment arms.(Up to 89 months)
研究者
研究点 (55)
Loading locations...
相似试验
Unknown
3 期
TPF Induction Chemotherapy vs PF Adjuvant Chemotherapy Combined With Concurrent Chemoradiotherapy in the Treatment of Locally Advanced NPCLocally Advanced Nasopharyngeal CarcinomaNCT03574324Guiyang Medical University266
招募中
3 期
Chemotherapy Omission in ER+/HER2- Breast Cancer With 1-3 Positive Lymph Nodes Receiving Extended Adjuvant AbemaciclibBreast CancerNCT06341621Fudan University1,900
Unknown
3 期
GP Induction Chemotherapy us TPF Adjuvant Chemotherapy Combined With DDP Concurrent Chemoradiotherapy in the Treatment of Locally Advanced NPCLocally Advanced Nasopharyngeal CarcinomaNCT03604965Guiyang Medical University204
已完成
3 期
Study Evaluating Efficacy and Safety of FFX Versus Combination of CPI-613 With mFFX in Patients With Metastatic Adenocarcinoma of the PancreasPancreatic Cancer MetastaticNCT03504423Cornerstone Pharmaceuticals528
已完成
2 期
Study of Chemotherapy Combination With Autologous Cytokine-Induced Killer Cell Immunotherapy to Treat Lung CancerNon-small Cell Lung CancerSquamous Cell CarcinomaNCT01631357Tianjin Medical University Cancer Institute and Hospital96