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
试验速览
- 阶段
- 2 期
- 状态
- 终止
- 入组人数
- 137
- 试验地点
- 20
- 主要终点
- Overall Tumor Response at the Primary Tumor Site Based on Measurement of Primary Tumor Volume (Excluding Involved Lymph Nodes) by Spiral CT
研究概览
简要总结
OncoGel is a new experimental drug delivery system that allows the slow continuous release of paclitaxel (an approved intravenous anticancer drug), from a gel (ReGel) over a long period of time. The gel will disappear in 4 to 6 weeks as it releases the paclitaxel.
The protocol is directed towards evaluating the efficacy and safety of paclitaxel delivered as a local, intralesional treatment when used in combination with chemotherapy (cisplatin and 5-FU) and radiation therapy before surgery.
详细描述
The primary objective of this study is to evaluate the efficacy of OncoGel given in combination with standard chemotherapy (cisplatin and 5-FU) and radiation therapy in patients with previously untreated, resectable, local or local-regional adenosarcoma or squamous cell carcinoma.
All patients will receive IV cisplatin on Day 1 and Day 29 and IV 5-FU given continuously for 96 hours starting on Day 1 and Day 29. All patients will also receive out-patient radiation therapy for 28 treatments once per day for 5 1/2 weeks starting on Day 1.
Patients randomized to the OncoGel treatment group will have the OncoGel dose injected into their esophageal tumors during an endoscopic procedure just before starting systemic chemotherapy and radiation therapy.
All patients will have CT scans for tumor measurements before starting chemotherapy and 12 weeks later after completion of the radiation therapy and both cycles of chemotherapy.
During the chemotherapy and radiation therapy, physical exams, vital signs, routine blood tests will be performed. Patients will also be asked about their quality of life and ability to swallow.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Treatment
- 盲法
- Single (Outcomes Assessor)
入排标准
- 年龄范围
- 18 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Histologically or cytologically confirmed squamous cell carcinoma or adenocarcinoma of the esophagus. Stage T2-T3, N any, M0 (no evidence of disseminated cancer except regional involvement which may be designated as "M1a"). No evidence of metastatic disease
- •Medically able to tolerate major abdominal and/or thoracic surgery
- •Able to undergo EUS procedure and pass EUS probe through esophageal lumen
- •Able to receive concurrent systemic chemotherapy (cisplatin and 5-FU) and RT
- •Clinical management plan includes esophagectomy after completion of two courses of chemoradiation therapy
- •Karnofsky Performance Status of ≥ 60
- •Minimum life expectancy of 4 months
- •Hematologic function
- •Absolute neutrophil count (ANC) ≥ 1500/mm3
- •Platelet count ≥ 100,000/mm3
- •Hemoglobin ≥ 9 g/dL
- •Hepatic function:
- •Total bilirubin < 1.5 X upper limit of normal (ULN)
- •AST and ALT < 3 X ULN
- •Albumin ≥ 3.0 g/dL or ≥ 2.0 g/dL if the lower level is considered by the investigator to be due to nutritional depletion
- •Serum creatinine < 1.5 mg/dL and/or creatinine clearance ≥ 65 mL/min
- •≥ 18 years old
- •If female, must be non-pregnant, nonlactating, of non-childbearing potential, or using adequate birth control
- •Capable of understanding and agreeing to fulfill the requirements of the protocol
- •Sign the IRB/EC approved consent form
排除标准
- •History of anaphylaxis to planned CT contrast agent
- •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.
- •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. Subjects with a history of low risk prostatic carcinoma (ie, clinical stage 1 or 2a, Gleason score < or = 6 and PSA <10 ng/mL at diagnosis) will be allowed
- •Significant currently active systemic diseases including uncontrolled diabetes, severe heart disease (New York Heart Association Class III or IV), 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 adversely affect subject safety
- •Known esophageal varices
研究组 & 干预措施
Group 1
OncoGel, radiation therapy and systemic chemotherapy (cisplatin plus 5-FU) prior to surgical resection.
干预措施: cisplatin (Drug)
Group 1
OncoGel, radiation therapy and systemic chemotherapy (cisplatin plus 5-FU) prior to surgical resection.
干预措施: OncoGel (Paclitaxel gel) (Drug)
Group 1
OncoGel, radiation therapy and systemic chemotherapy (cisplatin plus 5-FU) prior to surgical resection.
干预措施: 5-FU (Drug)
Group 1
OncoGel, radiation therapy and systemic chemotherapy (cisplatin plus 5-FU) prior to surgical resection.
干预措施: radiation therapy (Radiation)
Group 1
OncoGel, radiation therapy and systemic chemotherapy (cisplatin plus 5-FU) prior to surgical resection.
干预措施: esophageal resection (Procedure)
Group 2
Radiation therapy and systemic chemotherapy (cisplatin plus 5-FU) prior to surgical resection.
干预措施: cisplatin (Drug)
Group 2
Radiation therapy and systemic chemotherapy (cisplatin plus 5-FU) prior to surgical resection.
干预措施: 5-FU (Drug)
Group 2
Radiation therapy and systemic chemotherapy (cisplatin plus 5-FU) prior to surgical resection.
干预措施: radiation therapy (Radiation)
Group 2
Radiation therapy and systemic chemotherapy (cisplatin plus 5-FU) prior to surgical resection.
干预措施: esophageal resection (Procedure)
结局指标
主要结局
Overall Tumor Response at the Primary Tumor Site Based on Measurement of Primary Tumor Volume (Excluding Involved Lymph Nodes) by Spiral CT
时间窗: Screening and Week 12
Per the Response Evaluation Criteria In Solid Tumors Criteria (RECIST v1.0) for target lesions and by Spiral CT assessment: Complete Response (CR) is the disappearance of all target lesions; Partial Response (PR) is a \>=30% decrease in the sum of the longest diameter of target lesions; Overall Response (OR) = CR + PR
次要结局
未报告次要终点