A Prospective Study to Evaluate Online Adaptive Radiotherapy in Postoperative Treatment of Endometrial and Cervical With Reduced Margin
试验速览
- 阶段
- 1 期
- 状态
- 进行中（未招募）
- 入组人数
- 17
- 试验地点
- 1
- 主要终点
- Physician-reported acute toxicity
研究概览
简要总结
Online adaptive radiotherapy (oART) has demonstrated to be feasible to reduce planning target volume (PTV) margins for postoperative treatment of endometrial and cervical cancer. To explore the value of reduced margins in oART for postoperative treatment of endometrial and cervical cancer, we conducted a prospective clinical trial to determine the clinical efficacy and toxicity of reduced margins.
详细描述
This is an investigator-initiated efficacious, single-center, open-label clinical trial study. This study hypothesizes that the use of reduced PTV margins in oART for postoperative treatment of endometrial and cervical cancer could decrease toxicity and achieve more accurate dosimetric coverage. A dose of 45 or 50.4 Gy is delivered to clinical target volume (CTV) with reduced margin oART. Patients receive cisplatin based concurrent chemotherapy. The primary endpoint is acute toxicity. The first 10 patients were included in the study that have demonstrated the feasibility of reducing the margin (ClinicalTrials.gov ID: NCT05682950).
研究设计
- 研究类型
- Interventional
- 分配方式
- Na
- 干预模型
- Single Group
- 主要目的
- Treatment
- 盲法
- None
入排标准
- 年龄范围
- 18 Years 至 70 Years（Adult, Older Adult）
- 性别
- Female
- 接受健康志愿者
- 否
入选标准
- •Patients must be informed of the investigational nature of this study and give written informed consent before treatment.
- •Postoperative endometrial and cervical cancer patients with pathologically confirmed no residual tumor at the resection margin and no evidence of distant metastasis (FIGO stage IVB).
- •Pathological findings indicate risk factors and adjuvant radiotherapy are prescribe.
- •Karnofsky score ≥
- •Subjects aged ≥ 18 years and ≤ 70 years.
- •No evidence of para-aortic metastatic lymph nodes.
- •No contraindications to CT scanning.
- •Subjects must be able to cooperate in completing the entire study.
- •Adequate marrow: neutrophile granulocyte count ≥1.5*10^9/L, hemoglobin ≥ 80 g/L, platelet count ≥100*10^9/L.
- •Normal liver and kidney function: Creatinine (Cr) < 1.5 mg/dl, Alanine Aminotransferase (ALT), Aspartate Aminotransferase (AST) < 2*upper limit of normal (ULN).
排除标准
- •Subjects who have received prior pelvic radiotherapy.
- •Subjects with other primary malignancies.
- •Subjects with contraindications to radiotherapy, as determined by the investigators.
- •Any severe disease which may bring unacceptable risk or affect the compliance of the trial, for example, unstable cardiac disease requiring treatment, renal disease, chronic hepatitis, diabetes with poor control, and emotional disturbance.
- •Active infection with fever.
- •Active inflammatory bowel disease.
研究组 & 干预措施
Online Adaptive Radiotherapy
Patients receive online adaptive radiotherapy with 5mm PTV margin. The CTV-N covered pelvic lymph nodes (common, internal and external iliac, obturator, and presacral) and CTV-V covered proximal vagina and any paravaginal or retracted parametrial tissue. A dose of 45 or 50.4Gy is delivered to CTV with online adaptive radiotherapy.
干预措施: Online adaptive radiotherapy (Radiation)
结局指标
主要结局
Physician-reported acute toxicity
时间窗: From the start of treatment to 3 months after treatment
Physician-reported acute toxicity evaluated with Common Terminology Criteria for Adverse Events (CTCAE) 5.0
次要结局
- The dose coverage of target volume as assessed by planing tumor volume V100%(Through study completion, an average of five month)
- Target automatically contouring accuracy(Through study completion, an average of five month)
- Late toxicity evaluated with Radiation Therapy Oncology Group (RTOG)/EORTC late radiation morbidity scoring scheme(2-year)
- Organs at risk contouring accuracy(Through study completion, an average of five month)