Chemotherapy Plus Radiation Therapy in Treating Patients With Primary Stage IVB Cervical Cancer: A Prospective, Single Arm, Phase II Clinical Trial
试验速览
- 阶段
- 不适用
- 入组人数
- 48
- 试验地点
- 1
- 主要终点
- Progression-free survival time, PFS
研究概览
简要总结
This is a prospective, single arm, phase II trail to assess the effect of primary lesion radiotherapy in the treatment of stage IVB cervical cancer on the basis of systemic chemotherapy.
详细描述
Because of the apparent heterogeneity of stage IVB cervical cancer, at present there is no standard treatment.
This is a Phase II, single-center, single-arm, study of systemic chemotherapy plus lesion radiotherapy for primary stage IVB cervical cancer.
The primary objective of the study is to test the hypothesis that primary lesion radiotherapy leads to an improvement in progression-free survival time (PFS)for stage IVB cervical cancer.
For those patients under the clinical management of the recruiting investigator, the investigator will review the patient's medical records and determine if they would be a candidate for the study.
Upon confirmation of all eligibility criteria, the subject will be enrolled.Patients with beyond abdominal pelvic lymph node metastasis will first undergo 2 cycle systemic chemotherapy（TP/TC），then to evaluate the efficacy of chemotherapy, and for patients with chemotherapy effective（CR+PR+SD) followed by the primary lesion of regional radiotherapy (external irradiation plus brachytherapy)，concurrent chemotherapy （TP/TC） may be given according to the patients tolerant，finally, the patient will complete a total of 6 cycles of chemotherapy（TP/TC）.Distant metastasis of lymph node areas (e.g., supraclavicular, axillary, mediastinum, etc.) will be radiation after radiotherapy at the primary site according to patients tolerant.Patients with stage IVB cervical cancer with hematogenous metastasiswill first undergo 4 cycle systemic chemotherapy（TP/TC），then to evaluate the efficacy of chemotherapy, and for patients with chemotherapy effective（CR+PR+SD) followed by the primary lesion of regional radiotherapy (external irradiation plus brachytherapy)，concurrent chemotherapy （TP/TC） may be given according to the patients tolerant，finally, the patient will complete a total of 6 cycles of chemotherapy（TP/TC），after the primary radiotherapy, the treatment regimen for distant metastasis will be determined by MDT discuss or consultation.Quality of life will be evaluated before and after treatment. During therapy, the patient will have a weekly physical exam, vital signs collected, evaluation for pain, and review any side effects.
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
- •Biopsy-proven, invasive carcinoma of the cervix(squamous cell carcinoma, adenocarcinoma and adenosquamous carcinoma )
- •FIGO stage IVB
- •ECOG (Eastern Cooperative Oncology Group) : 0-2
- •The expected survival time is >6 months
- •Chemotherapy and radiation have not been done before
- •Normal hemodynamic indices before the recruitment (including white blood cell count>4.0×109/L, neutrophil count>1.5×109/L, platelet count >100×109/L, hemoglobin≥90g/l, normal liver/kidney function)
- •Able to understand this study and have signed informed consent.
排除标准
- •Prior hysterectomy
- •Metastases lesions are confirmed by pathology or image and are excluded as the second primary neoplasm
- •Patients with brain metastasis or disseminated peritoneal metastasis
- •Female in pregnancy or lactating
- •Hypersensitivity of chemotherapeutic drugs (paclitaxel allergy)
- •History of major psychiatric disorder
- •Persons with physical or mental illness, without civil capacity or with limited capacity for civil conduct
- •Patient with any other disease or condition is a contraindication for chemoradiotherapy
- •The researchers consider the patient not appropriate to be enrolled
研究组 & 干预措施
Chemotherapy,radiotherapy
Lymphatic metastasis patients undergoing 2 cycles of chemotherapy(TP/TC), blood metastasis patients receiving 4 cycles of chemotherapy, then patients with therapeutic evaluation for (CR+PR+SD) will undergo the radiotherapy (external irradiation plus brachytherapy) for primary lesion area , all patients completed total 6 cycles of chemotherapy (TP/TC), and finally will determine the of treatment plans of metastasis areas based on tolerance and discuss results by MDT.
干预措施: Chemotherapy,radiotherapy (Radiation)
结局指标
主要结局
Progression-free survival time, PFS
时间窗: 2 years
Progression-free survival will be evaluated
次要结局
- Number of Patients with Adverse Events as a Measure of Safety(2 years)
- Objective Response Rates, ORR(2 years)
- Overall survival(2 years)
- Ranking Quality of Life of Patients(2 years)
- Screening for potentially curable primary stage IVB cervical cancer(2 years)