A Phase II, Randomized, Open-Label, Single-Center Study Comparing Intensity Modulated Proton Therapy Versus Volume Modulated Arc Therapy in Patients Receiving Pelvic Nodal Irradiation for Newly Diagnosed Gynecologic Primaries
试验速览
- 阶段
- 2 期
- 状态
- 招募中
- 入组人数
- 116
- 试验地点
- 9
- 主要终点
- Number of participants with treatment-related Acute Gastrointestinal Toxicity as assessed by CTCAE v 5.0
研究概览
简要总结
The purpose of study is to compare the side effects of two different forms of radiation for endometrial and cervical cancer. If you decide to enroll in this study, you will be randomized to one of two treatment groups. This study will compare two standard of care treatments: "Conventional" pHoton radiation versus pRoton radiation.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Treatment
- 盲法
- None
入排标准
- 年龄范围
- 18 Years 至 —（Adult, Older Adult）
- 性别
- Female
- 接受健康志愿者
- 否
入选标准
- •a. Newly diagnosed endometrial cancer after TAH/BSO and nodal sampling, sentinel LN biopsy or pelvic nodal dissection planning to receive sequential chemotherapy and radiation or concurrent chemoradiotherapy or b. cervical cancer planning to receive definitive chemoradiation with HDR brachytherapy boost
- •Histologic confirmation of malignancy (primary only)
- •≥ 18 years of age
- •ECOG performance status ≤ 2
- •Patient must have the ability to understand and the willingness to sign a written informed consent document or when appropriate, have an acceptable surrogate capable of giving consent on the subject's behalf.
- •Insurance approval for IMPT
排除标准
- •Metastatic disease beyond para-aortic lymph nodal region
- •Residual tumor after surgery exceeding 2 cm in maximum dimension in patients with endometrial cancer.
- •FIGO 2014 stage III-IVA cervix cancer planning to receive concurrent pembrolizumab.
- •Cervical cancer with inability to receive concurrent chemotherapy.
- •Any prior pelvic radiation.
- •Treatment with other investigational agents.
- •Carcinosarcoma.
- •Creatine clearance <30 mL/m2
- •Unable to lie flat during or tolerate radiation.
- •Refusal to sign informed consent.
- •Any additional active cancer that would interfere with the primary study endpoints
研究组 & 干预措施
Proton Radiation
Proton Radiation Therapy (Intensity Modulated Proton Therapy (IMPT))
干预措施: Intensity Modulated Proton Therapy (IMPT) (Radiation)
Photon Radiation
Photon Radiation Therapy (Volume Modulated Arc Therapy (VMAT))
干预措施: Volume Modulated Arc Therapy (VMAT) (Radiation)
结局指标
主要结局
Number of participants with treatment-related Acute Gastrointestinal Toxicity as assessed by CTCAE v 5.0
时间窗: 2-years following completion of treatment
To compare patient reported acute gastrointestinal toxicity specifically grade 2 or higher (CTCAE) diarrhea events between IMPT and VMAT for patients receiving pelvic nodal irradiation for newly diagnosed cervical and endometrial cancer.
次要结局
- Incidence of grade 4 (via CTCAE) lymphopenia during radiation between IMPT and VMAT(2-year following completion of treatment)
- Number of patients with decreased lymphocyte values at first follow-up visit post radiation(3 months post completion of RT)
- Number of patients with physician reported GI toxicities assessed by CTCAE v5(2 years post radiation treatment)
- Rates of treatment completion within scheduled time frame(2 years post treament)
- GI, GU and hematologic grade 2 or higher late toxicity events (via CTCAE)(2 years post treatment completion)
- Compare 2-year overall survival, local failure and distant failure(2 years post treatment completion)
研究者
Elizabeth Nichols
Principal Investigator
University of Maryland, Baltimore