EUCTR2006-001623-18-FR进行中（未招募）1 期
A Randomised, Double-Blind, Placebo-Controlled, Multi-centre, Phase III Study of Post-Operative Adjuvant Lapatinib or Placebo and Concurrent Chemoradiotherapy Followed by Maintenance Lapatinib or Placebo Monotherapy in High-Risk Subjects with Resected Squamous Cell Carcinoma of the Head and Neck (SCCHN)
适应症
试验速览
- 阶段
- 1 期
- 状态
- 进行中（未招募）
- 入组人数
- 688
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
入选标准
- •1. Willing and able to sign a written informed consent.
- •2. Histologically confirmed diagnosis of SCCHN of one of the following sites: oral cavity, oropharynx, hypopharynx and larynx.
- •3. Pathological Stage II, III or IVa with no evidence of gross residual disease, and at least one of the high risk factors by pathology (as listed in protocol)
- •4. Primary surgery with a curative intent completed within 4-6 weeks (and no later than 7 weeks) prior to randomization.
- •5. Subjects with a second primary tumor that has been resected at the same time as the original tumor according to the above criteria will be permitted in the study.
- •6. Complete recovery from the surgical procedure allowing for appropriate radiotherapy. Radiation therapy is required to start as soon as adequate healing has occurred. This is normally around 4-6 weeks but no later than 8 weeks after surgery.
- •7. Adequate tumour specimen from archived or resected tissue must be available.
- •8. Male or female, between 18 and 70 years of age.
- •Criteria for female subjects or female partners of male subjects as defined in the protocol
- •9. ECOG performance status 0, 1 or 2
- •10. Adequate haematology, renal and hepatic function , as defined in the protocol
- •11. Left ventricular ejection fraction (LVEF) within the institutional normal range as measured by ECHO (if ECHO cannot be performed or if the Investigator feels it is not conclusive to evaluate LVEF, then a MUGA scan should be performed).
- •12. Able to swallow and retain tablets whole or swallow a suspension of tablets dissolved in water at study inclusion.
- •13. Life expectancy of at least 6 months in the best judgement of the investigator
- •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. Nasopharyngeal, paranasal sinuses or nasal cavity tumours
- •2. Head and neck cancer with histology other than squamous cell carcinoma.
- •3. Evidence of distant metastases or gross post-operative residual disease.
- •4. Evidence of second primary tumour that was not resected or exhibits gross post-operative residual disease.
- •5. Any prior or current anticancer treatment of any kind – except the primary surgical resection. This will include but not exclusive to: prior tyrosine kinase inhibitors, prior neoadjuvant therapy, prior radiotherapy or use of any investigational agent.
- •6. Concurrent treatment with an investigational agent or participation in another clinical trial.
- •7. Concurrent use of CYP3A4 inducers or inhibitors while on investigational product. A standard 3-day course of dexamethasone for the prevention of cisplatin induced nausea and vomiting is permitted.
- •8. Subjects with known history of uncontrolled or symptomatic angina, arrhythmias, or congestive heart failure;
- •9. Pregnant or lactating females
- •10. History of another malignancy within the last 5 years, with the exception of completely resected basal or squamous cell skin cancer, or successfully treated in-situ carcinoma. History of non-invasive lesion or in-situ carcinoma, including in the head and neck region that was successfully treated with surgery, photodynamics or laser, will be permitted;
- •11. Peripheral neuropathy greater or equal to grade 2
- •12. Mal-absorption syndrome, disease significantly affecting GI function, or major resection of the stomach or bowel, that could affect absorption of lapatinib.
- •13. History of allergic reactions to relevant diuretics or anti-emetics (e.g. 5-HT3 antagonists) to be administered with cisplatin chemotherapy
- •14. History of allergic reactions attributed to compounds of similar chemical composition (quinazolines) to lapatinib
- •15. The investigator considers the subject unfit for the study as a result of the medical interview, physical examinations, or screening investigations
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