CTRI/2009/091/000739招募中2 期
An Investigator Initiated, Open Label, Randomized, Controlled, Multicentric Study, to assess the Safety and Efficacy of Nimotuzumab (BIOMAb-EGFR®) concurrent with Cisplatin and Radiotherapy in histologically Documented Squamous Cell Carcinoma of the Cervix.
Health Care Global Enterprises Ltd0 个研究点目标入组 110 人开始时间: 待定最近更新:
试验速览
- 阶段
- 2 期
- 状态
- 招募中
- 发起方
- 入组人数
- 110
研究概览
简要总结
暂无简介。
研究设计
- 研究类型
- Interventional
入排标准
入选标准
- •1. Patients with advanced squamous carcinoma of the uterine cervix, FIGO stage IIB-IIIB or patients with FIGO stage IB-IIA with biopsy-proven pelvic node metastases and/or tumor size >= 5 cm.
- •2. Patients must have measurable disease.
- •3. No chemotherapy exposure prior to study entry. No prior Radiotherapy.
- •4. Age > 18 years < 80 years at registration.
- •5. Life expectancy, as judged by the treating physician, of at least 6 months
- •6. Zubrod performance status < = 2
- •7. Patients must have normal organ and marrow function
- •8. Normal Chest X-Ray, Chest CT, or PET-CT with no distant metastatic lesion within 8 weeks prior to study entry.
- •9. Ability to understand and the willingness to sign a written informed consent document.
排除标准
- •1 Prior invasive malignancy (except non-melanomatous skin cancer) unless disease free for a minimum of 5 years.
- •2 Medical illness preventing the use of full-dose chemotherapy.
- •3 Patients who require the use of warfarin sodium > 1 mg.
- •4 Previous medical or psychiatric illness that would prevent informed consent or limit survival to less than six months.
- •5 Prior surgery to treat carcinoma of the cervix other than biopsy.
- •6 Patients with positive para-aortic disease
- •7 Previous pelvic radiation therapy including transvaginal irradiation to control bleeding.
- •8 Prior systemic chemotherapy.
- •9 Patients with active GI ulcers, GI bleeding, or active inflammatory bowel disease.
- •10 Pregnant, nursing or woman of childbearing potential who are sexually active and not willing/able to use medically acceptable forms of contraception.
- •11 Clinically significant cardiac disease.
- •12 Any other sytemic illness expected to delay/affect the treatment delivery as per the investigators? assessment.
- •13 Tumor outside the pelvis.
- •14 Serious, non-healing wound, ulcer, or current healing fracture.
- •15 Patients with a history of any type of fistula or gastrointestinal perforation.
- •16 Patients with known hypersensitivity to recombinant human antibodies.
- •17 Patients who are known to be HIV positive.
- •18 Prior therapy that specifically and directly targets the EGFR pathway
研究者
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