CTIS2023-507230-24-00招募中1 期
FIGO 2018 stage IB2 (>2 cm - =4 cm ) Cervical Cancer Treated with Neoadjuvant Chemotherapy Followed by Fertility Sparing Surgery (CoNteSSa) / Neo-Adjuvant Chemotherapy and Conservative Surgery in Cervical Cancer to Preserve Fertility (NeoCon-F)
niversity Health Network0 个研究点目标入组 95 人开始时间: 2023年9月6日最近更新:
适应症
试验速览
- 阶段
- 1 期
- 状态
- 招募中
- 发起方
- 入组人数
- 95
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
- 年龄范围
- 18 至 64（—）
入选标准
- •Eligibility Criteria for Neoadjuvant Chemotherapy: Patients must have histologically confirmed invasive cervical cancer with adenocarcinoma, adenosquamous or squamous histology and FIGO 2018 IB2 measuring >2 cm - =4 cm by radiological imaging (T2 sequence MRI). Lymphovascular space invasion (LVSI) is allowed, Eligibility Criteria for Neoadjuvant Chemotherapy: Patients must agree to use effective contraceptive methods prior to study entry, during study participation, and for at least one year after the FSS procedure. A serum pregnancy test within 72 hours prior to study registration is required., Eligibility Criteria for Fertility Sparing Surgery (FSS) Completed 3 cycles of neoadjuvant chemotherapy and achieved a complete response (CR) or partial response (PR) with reduction of the largest dimension of the lesion to <2 cm on physical examination and T2 sequence on MRI. For minimal MRI requirements: see Appendix F., Eligibility Criteria for Neoadjuvant Chemotherapy: Patients must be =18 years of age, and < 40 years of age, Eligibility Criteria for Neoadjuvant Chemotherapy: Patients must be premenopausal and wish to preserve fertility, Eligibility Criteria for Neoadjuvant Chemotherapy: At time of registration, patient may not have had any prior therapy to treat their cancer lesion, patients with diagnostic cone or LEEP are allowed but a measurable tumor of >2 cm - =4 cm is mandatory, Eligibility Criteria for Neoadjuvant Chemotherapy: Eastern Cooperative Group (ECOG) performance status = 2 (Karnofsky =60%, see Appendix C)., Eligibility Criteria for Neoadjuvant Chemotherapy: Within 7 days of the proposed start of treatment, patients must have normal organ and marrow function as defined: ? Haemoglobin > 100 g/L ? Leukocytes (WBC) > 3.0x109 /L ? absolute neutrophil count =1.5x109 /L ? platelets =100x109 /L ? total bilirubin within normal institutional limits ? AST(SGOT)/ALT(SGPT) =2.5 × institutional upper limit of normal ? creatinine within normal institutional limits, Eligibility Criteria for Neoadjuvant Chemotherapy: No evidence of active uncontrolled infection (patients on antibiotics are eligible)., Eligibility Criteria for Neoadjuvant Chemotherapy: Patient must have disease that is measurable per RECIST 1.1., Eligibility Criteria for Neoadjuvant Chemotherapy: Ability to understand and willing to sign a written informed consent document.
排除标准
- •Exclusion Criteria for Neoadjuvant Chemotherapy: Patients who have had chemotherapy or radiotherapy or surgery for their cancer. Patients with diagnostic cone or LEEP are allowed, Exclusion Criteria for Fertility Sparing Surgery: Suboptimal response to neoadjuvant chemotherapy according to local investigator, Exclusion Criteria for Fertility Sparing Surgery: Residual lesion > 2cm or disease progression while on chemotherapy, Exclusion Criteria for Neoadjuvant Chemotherapy: Patients who are receiving any other investigational agents., Exclusion Criteria for Neoadjuvant Chemotherapy: Patients with other cancers requiring ongoing treatment. Patients with malignancies unrelated to their cervical cancer can be included if they have not required treatment for 2 years. Patient with baso cellular skin cancer are allowed., Exclusion Criteria for Neoadjuvant Chemotherapy: Patients with known / evidence of brain metastases are excluded from participation in this clinical trial., Exclusion Criteria for Neoadjuvant Chemotherapy: History of allergic reactions attributed to compounds of similar chemical or biologic composition to paclitaxel, carboplatin, or cisplatin or other agents used in study., Exclusion Criteria for Neoadjuvant Chemotherapy: Uncontrolled inter-current illness including, but not limited to, ongoing or active infection, symptomatic congestive heart failure, unstable angina pectoris, cardiac arrhythmia, or psychiatric illness/social situations that would limit compliance with study requirements., Exclusion Criteria for Neoadjuvant Chemotherapy: Patients who are pregnant or breastfeeding, Exclusion Criteria for Neoadjuvant Chemotherapy: Any other condition that would, in the Investigator’s judgment, contraindicate the patient’s participation in the clinical study due to safety concerns or compliance with clinical study procedures, e.g., infection/inflammation, intestinal obstruction, unable to swallow medication, social/ psychological issues., Exclusion Criteria for Fertility Sparing Surgery: Patient unable to complete 3 cycles of neoadjuvant chemotherapy
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