A Prospective Study to Evaluate Online Adaptive Radiotherapy in Cervical Cancer With Reduced Margin
试验速览
- 阶段
- 1 期
- 状态
- 进行中（未招募）
- 入组人数
- 30
- 试验地点
- 1
- 主要终点
- Patient-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 cervical cancer. To explore the value of reduced margins in oART for 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 cervical cancer could decrease toxicity and achieve more accurate dosimetric coverage. A dose of 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.
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 75 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.
- •Age ≥18 years and ≤ 75 years.
- •Patients with newly histologically confirmed cervical cancer, including squamous cell carcinoma, adenocarcinoma and adenosquamous carcinoma, et al.
- •No evidence of para-aortic metastatic lymph nodes (MLNs) and inguinal lymph nodes on CT, MRI or positron emission tomograph (PET)/CT.
- •No contraindications to CT scanning.
- •No evidence of distant metastasis (FIGO stage IVB).
- •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
- •With common iliac MLNs.
- •Tumor extended to the lower third of the vagina.
- •Tumor spread to mucosa of the bladder or rectum.
- •Prior surgery (including pelvic or para-aortic lymph nodes resection, except for tumor biopsy), radiotherapy or chemotherapy to primary tumor or nodes.
- •Prior malignancy.
- •History of previous radiotherapy to the abdomen or pelvis.
- •Pregnancy or lactation.
- •Active inflammatory bowel disease, or history of severe stomach or duodenal ulcer.
- •Active infection with fever.
- •Patients with unacceptable risk that intracavitary brachytherapy can not be conducted.
- •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.
研究组 & 干预措施
Online Adaptive Radiotherapy
Patients receive online adaptive radiotherapy with 5-10mm PTV margin. The CTV contours of the following areas: gross tumor volume (GTV), cervix (if not already encompassed by the GTV), uterus, parametria, ovaries, vaginal tissue, obturator nodal chain, internal iliac nodal chain, external iliac nodal chain, presacral nodal chain and common iliac nodal chain. The upper border of CTV is at the level of aortic bifurcation. A dose of 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
Patient-reported acute toxicity
时间窗: From the start of treatment to 3 months after treatment
Patient-reported acute toxicity evaluated with European Organization for Research and Treatment of Cancer Quality of Life C30 (EORTC QLQ-C30) 3.0 questionnaire
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
- Movement of the uterus during per radiotherapy fractions(Through study completion, an average of eight month)
- Progression-free survival(2-year)
- Movement of the cervix during per radiotherapy fractions(Through study completion, an average of eight month)
- The irradiated doses of organs at risk(Through study completion, an average of eight month)
- The dose coverage of target volume as assessed by planing tumor volume V100%(Through study completion, an average of eight month)
- Late toxicity evaluated with Radiation Therapy Oncology Group (RTOG)/EORTC late radiation morbidity scoring scheme(2-year)
- Target volume contouring accuracy(Through study completion, an average of eight month)
- Response evaluation evaluated with RECIST 1.1(One month after treatment)
- Personalized margin for cervical cancer(Six month after treatment)