EUCTR2005-001506-29-ES进行中（未招募）不适用
PHASE I/II TRIAL OF ERLOTINIB, RADIATIONTHERAPY, AND CISPLATIN IN PATIENTS WITH COMPLETE RESECTED SQUAMOUS CELL CARCINOMA OF THE HEAD AND NECKEnsayo Fase I/II de Erlotinib en combinación con radioterapia y cisplatino en pacientes con carcinoma epidermoide de cabeza y cuello localmente avanzado resecado quirúrgicamente
Group of Clinical Investigation in Radiotherapy Oncology (GICOR)0 个研究点目标入组 90 人开始时间: 2005年9月13日最近更新:
相关药物
试验速览
- 阶段
- 不适用
- 状态
- 进行中（未招募）
- 发起方
- 入组人数
- 90
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. - Patients with histological proof of epidermoid carcinoma of the oral cavity, oropharynx, larynx, or hypopharynx, treated with surgical resection with curative intent.
- •2. - Surgical resection must have taken place within 8 weeks prior to the patient’s inclusion in the study.
- •3. - In those patients having clinical regional lymph node involvement radical neck dissection is mandatory. However, radical neck dissection is not an inclusion criterion in patients staged as N0.
- •4. - Age 18-70 years.
- •5. - Anticipated life expectancy of = 12 weeks.
- •6. - Patients should have at least one of the following criteria:
- •?Pathological T3-4 tumor stage, apart from T3N0 of the larynx with negative margins
- •?Pathological N2-3 nodal stage.
- •?Unfavorable pathological findings such as extranodal spread, positive resection margins, perineural and/or vascular involvement.
- •7. - Written informed consent given by the patient.
- •8. - Therapeutic compliance of the patient and geographical proximity to the hospital to facilitate appropriate follow-up.
- •9. - ECOG 0-1.
- •10. - No distant metastatic disease.
- •11. - Adequate organ function according to the following criteria:
- •a. Adequate bone marrow reserve: ANC > 1,5 x 10(9) cells/L; Platelet count > 100 x 10(9) cells/L; Hemoglobin > 9 g/dL
- •b. Liver function: Bilirubin < 1.5 x ULN; Alkaline phosphatase (AP), aspartate transaminase (AST) and alanine transaminase (ALT) < 3.0 x ULN
- •c. Renal function: calculated creatinine clearance (CrCl) > 60ml/min or Creatinine (Cr) < 1.5 ULN of the reference laboratory.
- •d. Serum calcium and alkaline phosphatase must be normal.
- •12. - Women of child bearing potential must have a negative pregnancy test within the 48h prior to the start of the treatment.
- •13. - Patients of both genders at a fertile age must follow effective contraceptive measures.
- •14. - Absence of symptomatic coronary artery disease or acute myocardial infarction within 6 months prior to study.
- •15. - Patients capable of oral deglutition or requiring gastrostomy.
- •16. - No problems of intestinal transit such as malabsorption syndrome, chronic inflammatory bowel disease and other diseases, which might impair drug absorption
- •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. - Histology other than squamous cell carcinoma.
- •2. - Presence of macroscopic residual disease.
- •3. - Previous treatment with chemotherapy or radiotherapy or EGFR-targeted agents.
- •4. - Incomplete resection of the primary tumor or incomplete neck dissection.
- •5. - Patients being diagnosed with any other malignant disease, excluding resected nonmelanoma skin cancer or resected uterine cervix carcinoma.
- •6. - Pregnant or nursing women.
- •7. - Active infection.
- •8. - Concomitant severe illness (according to the opinion of the investigator) or whose estimated survival for this concomitant pathology is lower than that estimated for the neoplasm disease.
- •9. - Uncontrolled psychiatric illness.
- •10. - Inability to take oral medication, requiring intravenous feeding or prior surgical procedures affecting absorption or having active peptic ulcer.
- •11. - Impossibility to appropriate follow-up.
- •12.- Evidence of any other disease, metabolic dysfunction, physical examination finding, or clinical laboratory finding suggesting a condition that contraindicates the use of the study medication (erlotinib, cisplatine, radiotherapy), which might interfere with the analysis of the results or increase the risk of treatment complications.
- •13.- Any known significant ophthalmologic abnormalities, including severe xerophthalmia, keratoconjunctivitis sicca, Sjögren syndrome, severe exposure keratopathy or other abnormalities, which may increase the risk of corneal epithelial damage (the use of contact lenses during the study may increase the risk of corneal damage and its use is strongly discouraged. Those patients still using contact lenses will need a closer ophthalmologic follow-up.
- •14. - Frequent vomiting or medical disorder impairing swallowing of drugs.
研究者
相似试验
进行中（未招募）
1 期
A Phase II Trial of Erlotinib as first line therapy in Non- Small Cell Lung Cancer over-expressing EGFR - Study of targeted Erlotinib treatment for Non-small cell lung cancerStage IIIb/IV non-small cell lung cancer (NSCLC) tumours that over-express EGFRMedDRA version: 9.1 Level: LLT Classification code 10025054 Term: Lung cancer non-small cell stage IIIBMedDRA version: 9.1 Level: LLT Classification code 10029522 Term: Non-small cell lung cancer stage IVEUCTR2007-001264-72-GBOxford Radcliffe Hospitals NHS Trust35
已完成
2 期
A Trial of Erlotinib + Radiotherapy for Cutaneous Squamous Cell CarcinomaCancerNCT00369512University of Alabama at Birmingham15
已完成
2 期
Phase II study of erlotinib monotherapy for patients with advanced stage of non-small cell lung cancer, undetectable epidermal growth factor receptor (EGFR) mutations by PNA LNA PCR clamp method, but positive immuno-staining with anti-EGFR mutation-specific antibodies.on-small cell lung cancerJPRN-UMIN000014299Dept. of Respiratory Medicine, Osaka Police Hospital7
已完成
2 期
Phase II study of erlotinib monotherapy for patients with untreated advanced non-small cell lung cancer, poor performance status and positive EGFR mutation status (OSAKA-LCSG1304)JPRN-UMIN000011473OSAKA-LCSG23
已完成
不适用
Phase II study of erlotinib as first line chemotherapy in patients with lung adenocarcinoma with brain metastasis and EGFR mutations.lung adenocarcinomaJPRN-UMIN000013502Osaka city General Hospital25