A Comparison of Acute Toxicities Between Patients Treated With Protons or Intensity-Modulated Radiation Therapy for Post-Operative Treatment of Endometrial or Cervical Cancers
试验速览
- 阶段
- 不适用
- 状态
- 招募中
- 发起方
- Mayo Clinic
- 入组人数
- 121
- 试验地点
- 9
- 主要终点
- Change in Expanded Prostate Cancer Index Composite (EPIC) Bowel score
研究概览
简要总结
This early phase I trial compares the side effects between patients treated with proton radiation therapy versus intensity modulated radiation therapy after surgery for the treatment of endometrial or cervical cancer. Radiation therapy uses high energy protons or x-rays to kill tumor cells and shrink tumors. Using quality of life questionnaires and adverse event assessments may help doctors learn whether proton radiation therapy is associated with lower acute gastrointestinal toxicities at the end of treatment compared to intensity modulated radiation therapy in patients with endometrial or cervical cancer.
详细描述
PRIMARY OBJECTIVE:
I. To assess whether proton radiation therapy (RT) is associated with lower acute gastrointestinal toxicities at the end of treatment compared to intensity modulated radiation therapy (IMRT) as measured with the Expanded Prostate Cancer Index Composite (EPIC) bowel domain.
SECONDARY OBJECTIVES:
I. To examine the association of bowel and bladder dose-volume histogram (DVH) with bowel and bladder toxicities, respectively.
II. To assess whether urinary toxicity rate is improved with proton RT compared to IMRT as measured with the EPIC urinary domain.
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 —（Adult, Older Adult）
- 性别
- Female
- 接受健康志愿者
- 否
入选标准
- •Histologically confirmed diagnosis of cervical or endometrial cancer
- •Must have undergone an open or robotic hysterectomy (total abdominal, vaginal, radical, or total laparoscopic) for carcinoma of the cervix or endometrium
- •History and physical prior to registration
- •Documentation of history of:
- •Smoking status
- •Pelvic infection
- •Pelvic inflammatory disease
- •Endometriosis
- •Planned to receive either proton or IMRT radiation treatment, with use of rectal balloon, at any Mayo Clinic site
- •Plan for RT to pelvis with or without para-aortic lymph node irradiation
- •If received high-dose chemotherapy prior to registration, last dose must have been given >= 21 days prior to start of RT
- •Complete blood count (CBC) performed within 21 days prior to registration
- •Computed tomography (CT), magnetic resonance imaging (MRI), positron emission tomography (PET)/CT, or PET/MRI for staging before registration; may be pre-operative (op) or post-op
- •Eastern Cooperative Oncology Group (ECOG) performance score 0-2
- •Provide written informed consent
- •Willing to complete quality of life (QOL) questionnaires
排除标准
- •Receiving external beam boost dose during RT
- •Distant metastases
- •Gross disease at time of RT
- •Histology of endometrial stromal sarcoma, leiomyosarcoma, melanoma or small cell carcinomas
- •Patients who exceed the weight/size limits of the treatment table
- •Positive or close surgical margins (=< 3 mm)
- •Prior RT to the pelvis
- •Planned to receive inguinal node RT
- •Hepatic insufficiency resulting in clinical jaundice and/or coagulation defects
- •Acquired immune deficiency syndrome (AIDS) based upon current Centers for Disease Control and Prevention (CDC) definition; note that human immunodeficiency virus (HIV) testing is not required for entry into this protocol. The need to exclude patients with AIDS from this protocol is necessary because the treatments involved in this protocol may be immunosuppressive.
- •Prior invasive malignancy (except non-melanomatous skin cancer) unless disease free for a minimum of 3 years
- •Severe, active co-morbidity defined as follows:
- •Unstable angina and/or congestive heart failure requiring hospitalization within the last 6 months
- •Transmural myocardial infarction within the last 6 months
- •Acute bacterial or fungal infection requiring intravenous antibiotics at the time of registration
- •Other major medical illness which requires hospitalization or precludes study therapy at the time of registration
- •Patients unwilling to have rectal balloon placed on a daily basis during RT
研究组 & 干预措施
Treatment (radiation therapy, questionnaires)
Patients undergo standard of care proton or intensity modulated radiation therapy. Patients also complete quality of life questionnaires and adverse event assessments over 10-15 minutes each at baseline, at the end of radiation therapy, and at 1 month, 1 year, and 3 years post-radiation therapy.
干预措施: Questionnaire Administration (Other)
Treatment (radiation therapy, questionnaires)
Patients undergo standard of care proton or intensity modulated radiation therapy. Patients also complete quality of life questionnaires and adverse event assessments over 10-15 minutes each at baseline, at the end of radiation therapy, and at 1 month, 1 year, and 3 years post-radiation therapy.
干预措施: Radiation Therapy (Radiation)
Treatment (radiation therapy, questionnaires)
Patients undergo standard of care proton or intensity modulated radiation therapy. Patients also complete quality of life questionnaires and adverse event assessments over 10-15 minutes each at baseline, at the end of radiation therapy, and at 1 month, 1 year, and 3 years post-radiation therapy.
干预措施: Quality-of-Life Assessment (Other)
结局指标
主要结局
Change in Expanded Prostate Cancer Index Composite (EPIC) Bowel score
时间窗: Baseline up to 3 years post-radiation therapy (RT)
Will be examined using analysis of covariance.
次要结局
- Well-being(Up to 3 years post-RT)
- Bowel and bladder dose-volume histogram (DVH) parameters(Up to 3 years post-RT)
- Change in EPIC Urinary score(Baseline up to 5 weeks)
- Incidence of grade 2+ hematologic toxicities(Up to 3 years post-RT)
- Progression-free survival(Up to 3 years post-RT)
- Change in overall patient quality of life(Baseline up to 3 years post-RT)
- Overall survival (OS)(Up to 3 years post-RT)