EUCTR2007-005051-42-BE进行中（未招募）1 期
A randomized study of the efficacy and safety of OncoGel™ treatment as an adjunctive therapy to systemic chemotherapy and concurrent external beam radiation prior to surgery in subjects with localized or loco-regional esophageal cancer
Protherics Salt Lake City, Inc0 个研究点目标入组 124 人开始时间: 2008年1月7日最近更新:
适应症
试验速览
- 阶段
- 1 期
- 状态
- 进行中（未招募）
- 发起方
- 入组人数
- 124
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) Disease criteria: Subject’s esophageal cancer must meet all of the following:
- •a) Confirmation: Histologically or cytologically confirmed squamous cell carcinoma or adenocarcinoma of the esophagus or gastroesophageal junction. Biopsy or cytology of the primary tumor or of involved regional lymph nodes is acceptable.
- •b) Stage: Tumors must be TNM stage T2-T3, N any, M0 (no evidence of disseminated cancer except regional nodes such as supraclavicular and celiac) as determined by endoscopic ultrasound.
- •c) Disease extent: Disease must be limited to the esophagus or the gastroesophageal junction, including:
- •i)Tumor does not extend more than 2 cm into the stomach
- •ii)Tumor does not extend into proximal one-third of the esophagus (Note: Bronchoscopy is required if tumor is <26 cm from the incisors or at or above the carina)
- •iii)No tracheal-esophageal fistulas present
- •iv) No apparent direct invasion by the tumor into the mucosa of the trachea or major bronchus as determined by bronchoscopy or other method.
- •v) No vascular invasion or involvement by the tumor
- •d) No evidence of metastatic disease: disease must be localized to the esophagus, including
- •i) no malignant cytology of the pleura, pericardium or peritoneum
- •ii) no radiographic evidence of distant organ involvement including lung, liver, bone or brain (Note: any imaging study suspicious of liver metastases must be followed up with a negative biopsy prior to enrolling subject in the study)
- •2) Medically able to tolerate major abdominal and/or thoracic surgery
- •3) Able to undergo EUS procedure and pass EUS probe through esophageal lumen
- •4) Able to receive concurrent systemic chemotherapy (cisplatin and 5-FU) and RT
- •5) Clinical management plan includes esophagectomy after completion of two courses of CRT
- •6) Karnofsky Performance Status of =60 (refer to Section 13.2 for details)
- •7) Minimum life expectancy of 4 months as determined by the Investigator
- •8) Adequate hematologic function, defined as
- •a) Absolute neutrophil count (ANC) =1500/mm3
- •b) Platelet count =100,000/mm3
- •c) Hemoglobin =9 g/dL
- •9) Adequate hepatic function, defined as
- •a) Total bilirubin <1.5 X upper limit of normal (ULN)
- •b) AST and ALT <3 X ULN
- •c) Albumin =3.0 g/dL
- •10) Adequate renal function, defined as
- •a) Serum creatinine <1.5 mg/dL and/or creatinine clearance =65 mL/min
- •11) =18 years old
- •12) If subject is female, she is of
- •a) Non-childbearing potential (defined as surgically sterile or one year post-menopausal)
- •b) Childbearing potential using adequate birth control and having a negative pregnancy test performed at Screening and again within 5 days of Dosing Day 1; adequate birth control measures are defined as hormonal, chemical or barrier methods or abstinence. Other birth control methods must receive Sponsor approval prior to subject enrollment
- •13) Capable of understanding and agreeing to fulfill the requirements of the protocol
- •14) Sign the IRB/EC approved consent form.
- •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
- •- History of anaphylaxis to planned CT contrast agent; subjects with history of minor, mild allergic reactions (eg, hives, rash, pruritis) to planned CT contrast agent may be premedicated with prednisone or other medications per institutional standard of care
- •- Prior esophageal stent insertion, laser or photodynamic therapy
- •- Prior chest RT or major esophageal surgery
- •- Any prior receipt of cytotoxic chemotherapeutic agents
- •- Prior receipt of other cancer treatments (ie, Chelation therapy), vaccines or biological response modifiers/growth factors (ie, GM-CSF, IL-2) within the past 4 weeks.
- •Note: hormonal therapies (eg, tamoxifen, anastrozole) and topical agents (eg, 5-FU, imiquimod) will be allowed; no washout period will be required for these agents.
- •- Prior malignancy unless disease free for =3 years
- •Note: basal cell/squamous carcinoma of the skin, in situ cervical or breast carcinoma, or superficial transitional cell bladder carcinoma will be allowed
- •- Significant currently active systemic diseases including uncontrolled diabetes, severe heart disease (New York Heart Association Class III or IV, see Section 13.4), uncontrolled hypertension, myocardial infarction within 3 months, severe bronchial obstruction, uncontrolled seizure disorder, or peripheral neuropathy greater than CTCAE grade 1
- •- Allergies to any of the active or inactive components of OncoGel (ie, allergies to degradable PLGA [poly(lactide-co-glycolide) sutures])
- •- Receipt of an investigational drug or device within 30 days prior to signing informed consent
- •- Any medical condition or other circumstance that, in the Investigator’s opinion, would prevent completion of the study, interfere with analysis of the study results, or potentially aversely affect subject safety.
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