EUCTR2009-016489-10-DE进行中（未招募）不适用
Phase II study of induction chemotherapy with TPF followed by radioimmunotherapy with Cetuximab and intensity modulated radiotherapy (IMRT) in combination with a carbon ion boost for locally advanced tumors of the oro- , hypopharynx and larynxTPF-C-HIT-Study - TPF-C-HIT
niversity of Heidelberg0 个研究点开始时间: 2010年5月4日最近更新:
适应症
相关药物
试验速览
- 阶段
- 不适用
- 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
- •I1.Signed written informed consent,
- •2.Age of 18 to 70 years,
- •3.Life expectancy of at least 6 month,
- •4.Ability of subject to understand character and individual consequences of clinical trial,
- •5.Histologically confirmed locally advanced (stage III or IV), non-metastatic squamous cell carcinoma of oro-, hypopharynx and larynx (T2-4, any N, M0),
- •6.Oral cavity or oro- , hypopharynx or laynx as the primary tumor site,
- •7.At least one uni-measurable lesion according to the RECIST criteria,
- •8.Karnofsky Performances Status > 70%,
- •9.Adequate bone marrow function: neutrophils > 1.5 x 109/L, platelets > 100 x 109/L, hemoglobin > 10.0 g/dL§,
- •10.Adequate liver function: Bilirubin < 1.5mg/dL, SGOT, SGPT < 3 x ULN§, GGT < 5 x ULN§,
- •11.Adequate renal function: GFR> 70 ml/min.§,
- •12.Negative serum/urine Beta-HCG test in women of childbearing potential,
- •13.Women of childbearing potential: willingness to use effective contraceptive method, defined as the concomitant use of either an intrauterine pessary (IUP) or contraceptive pill and in both cases, condoms for the treatment duration and 2 months thereafter. Women of non-childbearing potential are those who are post-menopausal for at least 1 year or sterilized,
- •14.Men of procreative potential: willingness for effective prevention of procreation, defined as a use of condoms and a use of either an intrauterine pessary (IUP) or a contraceptive pill by his partner for the treatment duration and 2 months thereafter,
- •15.Subject’s consent to collect blood and/or tumor tissue samples for proteomics and genomics. If a patient does not consent, no samples for proteomics and genomics will be taken. Nonetheless, he/she may be enrolled in the study.
- •§ If in the opinion of the responsible investigator the values excluding a subject from the trial participation are transient, the flagged inclusion criteria may be re-assessed (prior to inclusion). If the control values are within the normal range the subject may be enrolled in the trial.
- •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
- •Exclusion Criteria
- •1.Previous systemic chemotherapy, radiotherapy or surgery for carcinoma of the head, neck and larynx,
- •2.Nasopharyngeal Carcinoma,
- •3.Prior exposure to EGFR pathway targeting therapy,
- •4.Evidence of distant metastases.
- •5.Other serious illness or medical conditions:
- •?Unstable cardiac disease despite treatment, congestive heart failure NYHA grade 3 and 4,
- •?Significant neurologic or psychiatric disorders including dementia or seizures,
- •?Active disseminated intravascular coagulation,
- •?Other serious underlying medical conditions which in the opinion of investigator could impair the ability of the patient to participate in the study,
- •?Symptomatic peripheral neuropathy Common Toxicity Criteria (CTC) grade 2 or higher,
- •?Ototoxicity CTC grade 2 or higher, except if due to trauma or mechanical impairment due to tumor mass,
- •6.Participation in other interventional trial within the last 30 days§§,
- •7.Surgery within the last 30 days§§,
- •8.Known allergic/hypersensitivity reaction to any drugs scheduled for the study treatment,
- •9.Women: pregnant or breast-feeding,
- •10.Known drug abuse,
- •11.Other previous malignancy within 5 years, with exception of a history of a previous, adequately treated, basal cell carcinoma of the skin or pre-invasive carcinoma of the cervix,
- •12.Legal incapacity or limited legal capacity,
- •13.Medical or psychological condition which in the opinion of the investigator would not permit the patient to complete the study or sign meaningful informed consent.
- •§§ If appropriate, the inclusion of a subject may be postponed to comply with these exclusion criteria.
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