JPRN-jRCTs041190042招募中3 期
Adjuvant Chemotherapy Versus Radiotherapy For Postoperative Cervical Cancer ; a phase 3 trial - AFTER trial
Furusawa Akiko0 个研究点目标入组 250 人开始时间: 2019年6月17日最近更新:
适应症
试验速览
- 阶段
- 3 期
- 状态
- 招募中
- 发起方
- 入组人数
- 250
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
- >= 20age old 至 <= 75age old（—）
- 性别
- Female
入选标准
- •1)Primary FIGO stage IB1,IB2,IIA1,IIA2, and IIB cervical cancer after radical hysterectomy
- •2)Squamous cell carcinoma(SCC), adenocarcinoma, or adenosquamous cell carcinoma
- •3)Histologically pelvic lymph node metastasis and/or parametrial invasion
- •4)No metastasis to sites other than pelvic lymph node (swelling of more than 10 mm in shorter diameter) or no distant metastasis is found in chest/upper abdominal/pelvic enhanced CT or PET/CT performed within 56 days before surgery.Plain CT is permitted in case of allergy or asthma.
- •5)No pathological lymph node metastasis is found in any lymph node other than pelvic lymph node.
- •6)Type III radical hysterectomy is performed, and all of the following criteria are satisfied:
- •a)No macroscopic residual tumor with negative surgical margin (intraepithelial neoplasia is allowed)
- •b)More than 20 pathologically resected pelvic lymph nodes
- •c)Transverse cervical ligament is resected
- •d)More than 2 cm of paravaginal tissue/vagina resection length in resected specimen (before fixation)
- •e)Surgery was performed by operators who satisfied all of the following requirements:(Limited to sistes in Japan)
- •i.The surgeon-investigator is a gynecologic oncologist of the Japan Society of Gynecologic Oncology.
- •ii. The surgeon is a gynecologic oncologist or a gynecologic specialist of the Japan Society of Obstetrics and Gynecology.
- •7)The age at registration is over 20 years old and under 75 years old.
- •8)Eastern Cooperative Oncology Group (ECOG) performance status score is 0 or 1.
- •9)Within 42 days after surgery.
- •10)Initial treatment ( no past history of radiation or neoadjuvant chemotherapy)
- •11)Functions of the major organs (e.g., bone marrow, heart, liver, kidney) are maintained.
- •12)Written informed consent
排除标准
- •1)Residual tumor (including positive surgical margin).
- •2)Metastasis to the para-aortic node(pathological diagnosis or swelling of more than 10 mm in shorter diameter on CT image).
- •3)Have adnexal metastasis.
- •4)Have peritoneal metastasis
- •5)Have postoperative infection requiring systemic treatment.
- •6)Have serious concomitant conditions (e.g., liver/kidney/heart diseases, myelosuppression, infection).
- •7)Have intestinal paralysis or intestinal obstruction.
- •8)Suspected to have vesical fistula or rectal fistula.
- •9)Have concurrent diabetes mellitus (DM) under treatment or uncontrolled DM
- •10)Suspected to have interstitial pneumonia or pulmonary fibrosis on simple X-ray or CT scan images.
- •11)Active double cancer or double cancer with disease-free period of within 5 years.
- •However, carcinoma in situ or lesions equivalent to intramucosal carcinoma judged to have been cured by local treatment will not be included in active double cancers.
- •12)Have a past history of serious drug hypersensitivity.
- •13)Contraindicated with paclitaxel, carboplatin, or cisplatin.
- •14) Have a peritoneal or pleural fluid retention requiring treatment.
- •15) HBs antibody positive or HCV positive.
- •16) HIV antibody positive.
- •17) Have received continuous treatment with systemic steroid (oral or intravenous).
- •18) Have a past history of hypersensitivity to preparations containing polysorbate 80, preparations containing polyoxyethylene castor oil (Cremophor EL) (e.g., ciclosporin), and preparations containing hydrogenated castor oil (e.g., vitamins for injection).
- •19) Determined to be ineligible by the principal investigator.
- •20) Whilie breast-feeding.
研究者
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