KCT0003355已完成未知
A phase II trial of docetxel-PM plus oxaliplatin as a first-line chemotherapy in patients with esophageal squamous cell carcinoma
适应症
试验速览
- 阶段
- 未知
- 状态
- 已完成
- 入组人数
- 38
研究概览
简要总结
暂无简介。
研究设计
- 研究类型
- Interventional Study
入排标准
- 年龄范围
- 18(Year) 至 o Limit（—）
- 性别
- All
入选标准
- •(1) A patient whose squamous cell cancer of the esophagus or esophago-gastric junction has been confirmed by biopsy or cytology.
- •(2) A patient who is not subject to local treatment such as surgical excision or concurrent definitive chemoradiotherapy.
- •(3) Metastatic or relapsed esophageal cancer patients who planned first line palliative treatment.
- •(4) Patients’ age over 18
- •(5) Eastern Cooperative Oncology Group performance status (ECOG PS) score of 0-2
- •(6) Patient has measurable lesions with Response evaluation in solid tumor (Response Evaluation Criteria in Solid Tumors) v1.1
- •(7) Patients with appropriate organ functions, such as the following, within seven days prior to the start of a clinical trial
- •- Proper bone marrow function (ANC = 1500/uL, Platelets = 100,000/uL and Hb 8/uL )
- •- Proper kidney function (serum creatinine = 1.5 mg/L, 24-hour urine test or creatinine clearance = 60 ml/min based on Cockcroft-Gault formula)
- •- Appropriate liver function (bilirubin = 1.5 mg/dL, ALT and AST = 2.5 times normal upper limit)
- •(8) Patients with at least three months of an expected life.
- •(9) Signing written consent from patients or their legal guardians and understanding the right to withdraw consent at any time without disadvantage.
排除标准
- •(1) In the case that the following treatment has been received in the past for the local stage treatment more than 6 months from the end of the treatment, enrolment is allowed.
- •- Neoadjuvant chemotherapy
- •- Concurrent or sequential chemoradiotherapy
- •- Adjuvant chemotherapy
- •- Adjuvant concurrent or sequential chemoradiotherapy
- •- Definitive concurrent or sequential chemoradiotherapy
- •(2) Patients with a history of administration of docetaxel, paclitaxel, or oxaliplatin at any time in the past.
- •(3) Patients who have been treated for other active cancers other than esophageal cancer less than five years (but cured kin basal cell cancer or cured cervical CIS are excluded).
- •(4) The clinically confirmed esophagus obstruction, gastrointestinal bleeding, or perforation (except if the symptoms are sufficiently controlled through proper procedures such as stents).
- •(5) Patients with significant, uncontrolled cardiovascular disease, infection, or infectious fever.
- •(6) Patients with uncontrolled brain metastasis.
- •(7) In the case of major surgery within the first two weeks of clinical trial treatment, the patient must recover sufficiently from the effects of this surgery.
- •(8) Patients with pregnancy, breast feeding, or future plans.
- •(9) Because of uncontrolled diabetes or diabetic neuropathy, patients who have any subjective symptoms regardless of their degree
- •(10) Patients who have taken antihistamine or steroid within four weeks of clinical trial treatment
- •(11) In combination with the state of Docetaxel-PM, patients who are not permitted to take combined medication (patients with severe renal dysfunction, para-platin, platinum compound, patients who have hypersensitivity to mannitol, etc.)
- •(12) Patients with hypersensitivity history of Polysorbate 80
- •(13) A patient who has hypersensitivity history to Docetaxel-PM or oxaliplatin or any drug containing platinum.
- •(14) Patients with peripheral sensory neuropathy with functional impairment (may aggravate peripheral neuropathy) prior to clinical trial
- •(15) Other cases
- •- Have experienced an infection or other serious medical problems that could cause damage to a patient's functions, making it difficult for the patient to receive treatment in a research plan.
- •- mental, neurological, or dementia that can prevent a person from understanding and submitting a written statement and consent form
- •- Patients who are certain to be out of the clinical trial or who cannot be monitored regularly for the following reasons: For example, psychological, social, family or geographical reasons, or conditions that make it difficult to observe or comply with appropriate clinical trial plans.
- •- Incontrolled hepatitis and chronic liver disease
- •- Other patients who are judged unfit for clinical trials by their physicians and researchers
研究者
相似试验
进行中（未招募）
不适用
Phase II study: Treatment with the drug docetaxel and oxaliplatin for patients who have a confirmed metastatic or locally advanced cancer of the pancreas and in whom initial therapy has failed.EUCTR2005-004236-40-DEniversitätsklinikum Ulm44
进行中（未招募）
不适用
Phase II Study of Docetaxel, Oxaliplatin, Capecitabine with Bevacizumab and Trastuzumab in case of human epidermal growth factor receptor 2 (HER2)-positivity inPatients with Locally Advanced or Metastatic Gastric Cancer or Adenocarcinoma of the Gastro-oesophageal Junction (B-DOCT study) - B-DOCT studyocally Advanced or Metastatic Gastric Cancer or Adenocarcinoma of the Gastro-oesophageal JunctionMedDRA version: 12.1Level: PTClassification code 10063916Term: Metastatic gastric cancerMedDRA version: 12.1Level: LLTClassification code 10017758Term: Gastric cancerMedDRA version: 12.1Level: LLTClassification code 10066896Term: HER-2 positive gastric cancerEUCTR2010-022699-30-NLederlands Kanker Instutuut-Antonie van Leeuwenhoek Ziekenhuis
已完成
2 期
Phase II Study of Docetaxel, Oxaliplatin, Capecitabine with Bevacizumab and Trastuzumab in case of human epidermal growth factor receptor 2 (HER2)-positivity in Patients with Locally Advanced or Metastatic Gastric Cancer or Adenocarcinoma of the Gastro-oesophageal Junction (B-DOCT study)locally advanced or metastatic gastric cancer or adenocarcinoma of the gastro-oesophageal junctionmetastatic gastric cancer10017990NL-OMON39414Antoni van Leeuwenhoek Ziekenhuis90
已完成
2 期
Docetaxel and Oxaliplatin in Gastric CancerStomach NeoplasmsNCT00382720Sanofi275
招募中
2 期
The Phase II Study of Docetaxel plus Nedaplatin as Adjuvant Chemotherapy in Patients with Completely Resected Stage IB-IIIA Non-Small Cell Lung Canceron-small cell lung cancerJPRN-UMIN000004634Shiga University of Medical Science30