ISRCTN54531450已完成2 期
Phase II/III clinical trial of intensity modulated radiation therapy with concurrent cisplatin for stage I-IVA cervical carcinoma
niversity of California, San Diego0 个研究点目标入组 425 人开始时间: 2012年4月27日最近更新:
适应症
试验速览
- 阶段
- 2 期
- 状态
- 已完成
- 发起方
- 入组人数
- 425
研究概览
简要总结
2017 phase II results in: https://www.ncbi.nlm.nih.gov/pubmed/28126303 (added 11/04/2019)
研究设计
- 研究类型
- Interventional
入排标准
- 性别
- All
入选标准
- •1. Biopsy-proven, invasive squamous cell carcinoma, adenocarcinoma, or adenosquamous carcinoma of the cervix
- •2. Biopsy result positive for carcinoma within 60 days prior to registration
- •3. FIGO clinical stage I-IVA disease, based on standard diagnostic workup, including:History/physical examination and/or Examination under anesthesia (if indicated)
- •4. If the patient is status post hysterectomy, one or more of the following conditions must be present: positive lymph nodes, positive margins, parametrial invasion, or non-radical surgery (i.e., simple hysterectomy).
- •5. If the patient is inoperable, one or more of the following conditions must be present: clinical stage IB2-IVA, positive lymph nodes on nodal sampling or frozen section, and/or parametrial invasion
- •6. Within 42 days prior to registration, the patient must have any of the following, if clinically indicated: examination under anesthesia, cystoscopy, sigmoidoscopy, rigid proctoscopy, or colonoscopy.
- •7. X-ray (PA and lateral), CT scan, or PET/CT scan of the chest within 42 days prior to registration;
- •8. CT scan, MRI, or PET/CT of the pelvis within 42 days prior to registration
- •9. Karnofsky Performance Status 60-100
- •10.1. Absolute neutrophil count (ANC) = 1500 cells/mm3
- •10.2. Platelets = 100,000 cells/mm3
- •10.3. Hemoglobin = 10.0 g/dl (Note: The use of transfusion or other intervention to achieve Hgb = 10.0 g/dl is acceptable)
- •10.4. Creatinine clearance = 50 mg/dl
- •10.5. Bilirubin < 1.5 mg/dl
- •10.6. WBC = 3,000/µl
- •10.7. ALT/AST < 3 x ULN
- •10.8. INR = 1.5
- •11. Negative serum pregnancy test for women of child-bearing potential
排除标准
- •1. Prior invasive malignancy (except non-melanomatous skin cancer), unless disease free for a minimum of 3 years
- •2. Prior systemic chemotherapy within the past three years
- •3. Prior radiotherapy to the pelvis or abdomen that would result in overlap of radiation therapy fields;
- •4. Para-aortic, inguinal, or gross (unresected) pelvic nodal metastasis. Gross pelvic nodal metastasis is defined as either: Radiographic evidence of nodal metastasis on CT or MRI (node having short axis diameter > 1 cm)OR Radiographic evidence of nodal metastasis on diagnostic FDG-PET or PET/CT scan (abnormally increased FDG uptake as determined and documented by the radiologist)OR Biopsy-proven metastasis (e.g. needle biopsy) in undissected node
- •5. Distant metastasis
- •6. Unstable angina and/or congestive heart failure requiring hospitalization within the past 6 months
- •7. Hepatic insufficiency resulting in clinical jaundice and/or coagulation defects
- •8. Uncontrolled diabetes, defined as diabetes mellitus, which in the opinion of any of the patient's physicians requires an immediate change in management
- •9. Uncompensated heart disease or uncontrolled high blood pressure
- •10. Acquired Immune Deficiency Syndrome (AIDS) based upon current CDC definition
研究者
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