CTRI/2019/04/018382尚未招募3 期
Phase III Randomized study of concurrent chemotherapy and pelvic radiation therapywith or without adjuvant chemotherapy inhigh-risk patients with early-stage cervicalcarcinoma following radical hysterectomy. - RTOG
RG National Research Group Oncology0 个研究点目标入组 0 人开始时间: 待定最近更新:
试验速览
- 阶段
- 3 期
- 状态
- 尚未招募
- 发起方
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 must have undergone radical hysterectomy (open, laparoscopically or robotic) and staging including both para-aortic and pelvic node sampling for cervical carcinoma within 70 days prior to study entry.
- •2. Patients with clinical stage IA2, IB or IIA squamous, adenosquamous, or adenocarcinoma of the cervix who have any/all of the following high-risk features after surgery:
- •2.1 Positive pelvic nodes
- •2.2 Positive parametrium
- •2.3 Positive para-aortic nodes- completely resected, PET/CT negative (PET only required if positive para-aortic nodes during surgery)
- •3. No distant metastases, based upon the following minimum diagnostic workup [NOTE: Patients with positive para-aortic nodes- completely resected, PET/CT negative are eligible]
- •3.1 History/physical examination within 56 days prior to study entry
- •3.2 Contrast-enhanced imaging of the abdomen and pelvis by either CT, MRI, or PET-CT (whole body) within 90 days prior to registration. (NOTE: whole body PET-CT is preferred)
- •3.3 Chest x-ray (PA and lateral) or chest CT within 70 days prior to study entry (except for those who have had whole body PET-CT per Section 3.1.3.2).
- •4. Zubrod performance status 0-1.
- •5. CBC/differential obtained 14 days prior to study entry, with adequate bone marrow function defined as follows:
- •5.1 Absolute neutrophil count (ANC) >= 1,800 cells/mm3
- •5.2 Platelets >= 100,000 cells/mm3
- •5.3 Hemoglobin >= 10.0 g/dl (Note: The use of transfusion or other intervention to achieve Hgb >= 10.0 g/dl is acceptable.)
- •5.4 White blood cell count >= 4000 cells/mm3
- •6. Adequate hepatic and renal function defined as follows:
- •6.1 Serum creatinine <= 1.5 mg/dL within 14 days prior to study entry
- •6.2 Bilirubin <= 1.5 times normal 14 days prior to study entry
- •6.3 Alkaline phosphatase within upper limits of institutional normal within 14 days prior to study entry
- •6.4 AST/SGOT within upper limits of institutional normal within 14 days prior to study entry
- •6.5 Patients with known HIV positive must have a CD4 cell count be >= 350 cells/mm3 within 14 days prior to study entry (note, however, that HIV testing is not required for entry into this protocol.)
- •7. Patient must provide study-specific informed consent prior to study entry.
排除标准
- •1. Prior invasive malignancy (except non-melanomatous skin cancer) unless disease free for a minimum of 3 years (For example, carcinoma in situ of the breast, oral cavity, or cervix are all permissible)
- •2. Patients can not have any neuroendocrine histology in pathology.
- •3. Prior systemic chemotherapy for the current cervical cancer; note that prior chemotherapy for a different cancer is allowable.
- •4. Prior radiation therapy to the pelvis that would result in overlap of radiation therapy fields
- •5. Severe, active co-morbidity, defined as follows:
- •5.1 Unstable angina and/or congestive heart failure requiring hospitalization within the last 6 months
- •5.2 Transmural myocardial infarction within the last 6 months
- •5.3 Acute bacterial or fungal infection requiring intravenous antibiotics at the time of study entry
- •5.4 Chronic obstructive pulmonary disease exacerbation or other respiratory illness requiring hospitalization or precluding study therapy at the time of study entry
- •5.5 Coagulation defects; note, however, that coagulation parameters are not required for entry into this protocol.
- •6 Prior allergic reaction to carboplatin, paclitaxel, and/or cisplatin.
- •7. Patients who have gross residual disease or distant metastatic disease.
研究者
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