NCT03618706Unknown2 期
A Phase II Trial of Standard of Care Therapy With Involved Field Radiation Therapy for Selective Recurrent Ovarian Cancer
适应症
干预措施
试验速览
- 阶段
- 2 期
- 入组人数
- 107
- 试验地点
- 2
- 主要终点
- 2-year progression-free survival (PFS)
研究概览
简要总结
This study aims to investigate the effect of involved-field radiotherapy for recurrent ovarian cancer after primary standard treatment. We will investigate whether the addition of involved-field RT improves 2-year PFS in those patients than that of historical data (only with other standard salvage treatments as systemic chemotherapy ± maximum tumor resection).
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
- 19 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Pathologically confirmed ovarian carcinoma
- •Patients who received "standard treatment" for each stage as a primary treatment
- •No. of recurrent lesions:
- •If, all in lung, or intra-abdominal or pelvis organs - ≤ 5 If, any in liver, bone, or spinal cord - ≤ 2
- •Size of recurrent lesions ≤5 cm
- •All recurrent lesions are available for involved-field radiotherapy
- •Within 60 days before enrollment:
- •Absolute neutrophil count ANC ≥ 500 / mm3
- •Platelet ≥ 50,000 / mm3
- •Hb ≥ 8.0 g / dl
- •Good performance status (ECOG 0-1)
排除标准
- •Brain metastasis
- •Diffuse peritoneal carcinomatosis
- •Malignant pleural effusion
- •History of previous salvage radiotherapy for recurrent lesions
- •History of other malignancy or severe/unstable medical condition
研究组 & 干预措施
involved-field RT + standard salvage treatment
Experimental
Patients receiving involved-field RT on recurred lesions + standard salvage treatment for recurrent ovarian cancer
干预措施: Involved-field radiotherapy (Radiation)
结局指标
主要结局
2-year progression-free survival (PFS)
时间窗: 2 years after radiotherapy
次要结局
- Local control of recurred lesions(2 years after radiotherapy)
- Any other new recurrence events(2 years after radiotherapy)
- Radiotherapy-related complications(2 years after radiotherapy)
- Chemotherapy-free interval (The interval to delay the need for a new chemotherapy regimen for disease progression)(2 years after radiotherapy)
研究者
研究点 (2)
Loading locations...
相似试验
已完成
2 期
FOcal Radiation for Oligometastatic Castration-rEsistant Prostate Cancer (FORCE)Prostate CancerNCT03556904University of Michigan Rogel Cancer Center14
终止
1 期
Trial of Vaccine Therapy in Recurrent Platinum Sensitive Ovarian Cancer PatientsRecurrent Epithelial Ovarian CancerNCT01334047Steinar Aamdal5
Unknown
2 期
Tomotherapy in Postsurgery Recurrent Carcinoma CervixPostsurgery Recurrent Carcinoma CervixNCT01117402Tata Memorial Hospital90
已完成
2 期
SBRT + PD-1/PDL-1 Inhibiting Therapy for Advanced Solid Tumors After Dz Control on PD-1/PDL-1 TxSolid TumorNCT03220854Virginia Commonwealth University5
撤回
1 期
Activated T-cell Therapy, Low-Dose Aldesleukin, and Sargramostim in Treating Patients With Ovarian, Fallopian Tube, or Primary Peritoneal Cancer That is Stage III-IV, Refractory, or RecurrentMalignant Ovarian Clear Cell TumorMalignant Ovarian Serous TumorRecurrent Fallopian Tube CarcinomaRecurrent Ovarian CarcinomaRecurrent Primary Peritoneal CarcinomaStage IIIA Fallopian Tube CancerStage IIIA Ovarian CancerStage IIIA Primary Peritoneal CancerStage IIIB Fallopian Tube CancerStage IIIB Ovarian CancerStage IIIB Primary Peritoneal CancerStage IIIC Fallopian Tube CancerStage IIIC Ovarian CancerStage IIIC Primary Peritoneal CancerStage IV Fallopian Tube CancerStage IV Ovarian CancerStage IV Primary Peritoneal CancerNCT02470559Barbara Ann Karmanos Cancer Institute