FDG PET-CT Based Risk Adapted Radiotherapy Vs Observation for Post Chemotherapy Residual Mass in Advanced Seminoma: a Prospective Randomised Controlled Trial
试验速览
- 阶段
- 不适用
- 状态
- 招募中
- 入组人数
- 74
- 试验地点
- 2
- 主要终点
- Progression free survival(PFS)
研究概览
简要总结
Testicular tumors account for 1% of all cancers in males and germ cell tumors comprise 95% of all testicular cancers. Seminomas consist of around 50% of cases. However,adequate information is not there as 60- 80% residual disease is seen even after with the standard management of chemotherapy.
With the advent of functional imaging there was hope that it could aid in more accurately targeting these tumors to systematically evaluate the role of PET-CT imaging in identifying patients diagnosed with stage IIB-IIIC seminomatous germ cell tumor, with residual visible tumor post chemotherapy who would benefit with loco regional radiotherapy.
The therapeutic research in Seminomashas been relatively slow and such structured studies can allow analysis of large number of patients to report on acute and late effect of treatment outcomes using CTCAE and QOL (EORTC QLQ C-30) in these cancers. We hope that we will get help in identifying thrust areas for future research through this study.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 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 80 Years（Adult, Older Adult）
- 性别
- Male
- 接受健康志愿者
- 否
入选标准
- •Histological diagnosis of classical seminoma
- •Primary site - testis, mediastinum or retroperitoneum
- •Stage IIB-IIIC (AJCC 8th edition)
- •Age>18 years
- •Karnofsky Performance Status at least 70
- •A response assessment FDG PETCT scan done at least twelve weeks after the first line chemotherapy, showing a persistent measurable residual mass
- •Patient willing and reliable for follow up and QOL.
排除标准
- •Histology other than classical seminoma
- •Non completion of planned first-line chemotherapy
- •Prior history of radiotherapy to the involved region
- •Inability to deliver adequate radiotherapy dose safely based on assessment by radiation oncologist
研究组 & 干预措施
Radiotherapy
Patients randomized to the test arm will undergo radiotherapy to the residual mass. Patients will be stratified by the size of the residual mass in shortest dimension being <3 cm or > 3 cm.A dose of 30-36 Gy in conventional fractionation of 1.8-2.0 Gy per fraction using 3-dimensional conformal technique. Radiotherapy will be delivered five days a week.
干预措施: Radiotherapy (Radiation)
Observation
Patients randomized to the standard arm will be observed and the status of residual mass monitored with an FDG PETCT scan done at three to six monthly intervals.
结局指标
主要结局
Progression free survival(PFS)
时间窗: 2 years
• Progression free survival (PFS) is defined as the time period from the date of enrolment in the study till the first observation of disease progression at any site, or death.
次要结局
- Late radiation toxicity(2 years)
- Patient-reported quality of life (QOL)(2 years)
- Locoregional control (LRC)(2 years)
- Acute radiation toxicity(2 years)
- Overall survival (OS)(2 years)
- Second-line salvage therapy-free survival(2 years)
研究者
Dr Vedang Murthy
Professor
Tata Memorial Centre