KCT0006893尚未招募未知
Adjuvant Chemotherapy Versus Radiotherapy For Postoperative Cervical Cancer (AFTER): A Phase 3 Trial
试验速览
- 阶段
- 未知
- 状态
- 尚未招募
- 入组人数
- 50
研究概览
简要总结
暂无简介。
研究设计
- 研究类型
- Interventional Study
入排标准
- 年龄范围
- 20?(Year) 至 75?(Year)（—）
- 性别
- Female
入选标准
- •1) Preoperative clinical stage IB1, IB2, IIA1, IIA2, or IIB cervical cancer
- •2) In case of histological diagnosis as follows from the tumor tissue after surgery
- •- Squamous cell carcinoma (keratinizing type, nonkeratinizing type)
- •- Adenocarcinoma (usual type of endocervical adenocarcinoma, intestinal type of mucinous carcinoma, endometrioid carcinoma)
- •- Adenosquamous cell carcinoma
- •3) Pathologically confirmed pelvic lymph node metastasis or uterine chamber invasion from surgically resected tissue
- •4) In contrast-enhanced CT performed within 56 days before surgery, there should be no metastases other than pelvic lymph nodes (short diameter =10 mm) or distant metastases to the chest, upper abdomen, or pelvis, even when PET/CT was performed instead of contrast-enhanced CT Recognition. Simple CT is also permitted if it is difficult to use a contrast medium due to complications such as allergies or bronchial asthma.
- •5) There should be no lymph node metastasis other than the surgically resected pelvic lymph node. For invasive cancer, the incision should be negative. Intraepithelial lesions in the cut plane are acceptable.
- •6) Type III radical hysterectomy is performed by laparotomy or laparoscopy, and all of the following conditions must be met.
- •- There should be no gross residual tumor and negative amputation
- •- More than 20 pathologically confirmed pelvic lymph nodes
- •- Ligamentum cardinal amputation
- •- The vaginal incision (length from the vaginal fornix) measured before fixation is more than 2 cm
- •- The operating surgeon must meet the following requirements
- •? Gynecologic oncology expert recognized by the Korea Society of Gynecologic Oncology
- •? Gynecological oncologist or obstetrician-gynecologist recognized by the Korea Society of Obstetrics and Gynecology
- •7) At the time of registration, age 20 or older, 75 or younger
- •8) General condition ECOG score 0 or 1
- •9) Within 42 days after surgery
- •10) Primary treatment (previously radiotherapy or prior chemotherapy is not allowed)
- •11) Normal function of major organs (bone marrow, heart, liver, kidney, etc.)
- •In the inspection within 14 days before registration
- •- Neutrophil count: =1,500/mm3
- •- Platelet count: =100,000/mm3
- •- Hemoglobin level: =10.0 g/dL (values ??after blood transfusion will be acceptable)
- •- AST (GOT) and ALT (GPT): =100 IU/L
- •- Total bilirubin: =1.5 mg/dL
- •- Serum creatinine: =1.2 mg/dL
- •- Ccr (Modified Jelliffe equation): =50 mL/min
- •Modified Jlliffe equation
- •Ccr (mL/min) = [98 - {0.8 * (Age - 20)}] / Serum creatinine (mg/dL)
- •- ECG: Normal or minor changes not requiring treatment
- •12) When the consent form is signed
排除标准
- •1) Pathologically not completely resected (including positive amputation)
- •2) Aortic lymph node metastasis (short diameter =10 mm on pathological diagnosis or CT)
- •3) adnexal metastasis
- •4) peritoneal metastasis
- •5) Surgical water infection requiring systemic treatment
- •6) Serious comorbidities (liver/kidney/heart disease, myelosuppression, infection, etc.)
- •7) Intestinal insufficiency or intestinal obstruction
- •8) Bladder or rectal fistula
- •9) Diabetes mellitus that is being treated or not controlled by continuous insulin administration
- •10) Interstitial pneumonia or pulmonary fibrosis suspected on plain chest radiography or CT
- •11) Other cancers within 5 years of active or disease-free period. Intra-epithelial cancer or mucosal tumors that have been cured with local treatment are permitted.
- •12) History of serious drug hypersensitivity reaction
- •13) Contraindication to PTX, CBDCA or CDDP
- •14) ascites or pleural effusion requiring treatment
- •15) HBs antigen or HCV antibody positive
- •16) HIV antibody positive
- •17) During oral or intravenous systemic steroid treatment
- •18) If you have ever had a hypersensitivity reaction to Polysorbate 80, polyoxyethylene castor oil (Cremophor EL) (such as ciclosporin), or hydrogenated castor oil (such as vitamins for injection)
- •19) In case the lead researcher is judged to be ineligible
研究者
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