NCT00184093已完成1 期
Phase I/II Study of Gemcitabine and Concurrent Radiation Followed by Adjuvant Hysterectomy in Bulky Stage Ib and IIa Cervical Carcinoma: Analysis of Prognostic Factors and Determinants of Response: A Pilot Study
适应症
干预措施
相关药物
试验速览
- 阶段
- 1 期
- 状态
- 已完成
- 入组人数
- 35
- 试验地点
- 1
- 主要终点
- Toxicity (Number of Participants With Serious Adverse Events)
研究概览
简要总结
The purpose of this study is first to establish what is the ideal dose of gemcitabine, a chemotherapy agent, when given in combination with radiation. In addition, the investigators want to determine the side effects and the effectiveness of this combination. The investigators will also study several markers to try to identify markers or tests that will predict which patients will benefit more from this treatment.
研究设计
- 研究类型
- Interventional
- 分配方式
- Na
- 干预模型
- Single Group
- 主要目的
- Treatment
- 盲法
- None
入排标准
- 年龄范围
- 18 Years 至 —（Adult, Older Adult）
- 性别
- Female
- 接受健康志愿者
- 否
入选标准
- •Patients with histologically confirmed bulky stage Ib or stage IIa cervical cancer. Bulky stage Ib disease is defined as tumor mass greater than 4 cms in diameter.
- •Cervical lesion which is measurable by physical examination.
- •No prior therapy for invasive cervical cancer.
- •GOG performance status 0-2
- •Signed informed consent
- •Patients must have adequate:
- •Bone marrow function: absolute granulocyte count > or = to 1500, platelet count > 100,
- •Renal function: creatinine < or = to 1.8 mg/dl
- •Hepatic function: bilirubin < or = to 1.5 x normal, SGOT and alkaline phosphatase < or = to 3 x normal
排除标准
- •Patients with a history of prior malignancy, except adequately treated basal cell or squamous cell carcinoma of the skin, or other cancer for which the patient has been disease free for at least five years.
- •Pregnant or lactating women. Women of reproductive age may not participate unless they have agreed to use an effective method of birth control.
- •Patients with uncontrolled infection.
- •Patients who are HIV positive
- •Patients with psychiatric or social conditions that would interfere with consent or follow-up.
- •Patients with any other severe concurrent disease, which, in the judgment of the investigator, would make the patient inappropriate for entry into this study.
研究组 & 干预措施
Gemcitabine weekly x 6 wks with concurrent external radiation
Experimental
Gemcitabine 350 mg/m2 IV weekly x 6 weeks with concurrent external radiation
干预措施: Gemcitabine (Drug)
结局指标
主要结局
Toxicity (Number of Participants With Serious Adverse Events)
时间窗: Every 3 weeks from start of study until 30 days after the last dose of treatment
Summary of grade 3 or higher toxicities as per Common Toxicity Criteria version 2.0. Phase 1 and 2 Combined (N=35)
次要结局
- Best Overall Response of Either a Complete Response (CR) or Partial Response (PR)(Baseline to response (up to 24 months))
研究者
研究点 (1)
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