A Randomized Crossover Trial of Systemic Chemotherapy in Patients With Metastatic Well-Differentiated Mucinous Appendiceal Adenocarcinomas With Pseudomyxoma Peritonei
试验速览
- 阶段
- 不适用
- 状态
- 进行中（未招募）
- 入组人数
- 30
- 试验地点
- 1
- 主要终点
- Tumor Growth Rate
研究概览
简要总结
Appendiceal cancer is a rare disease that does not cause many symptoms. As such, doctors are not sure if chemotherapy actually has an effect on the disease. The goal of this clinical research study is to learn more about the effects that chemotherapy may have on appendiceal cancer.
详细描述
Study Groups:
If you are found to be eligible to take part in this study, you will be randomly assigned (as in the flip of a coin) to 1 of 2 study groups (cohorts):
- If you are in Cohort A, you will first be observed for 6 months, then you will receive chemotherapy for 6 months.
- If you are in Cohort B, you will first receive chemotherapy for 6 months, then you will be observed for 6 months.
You will have an equal chance of being assigned to either cohort. No matter which cohort you are in, the type of chemotherapy you receive will depend on the standard of care for the disease and what your doctor thinks is in your best interest. You will sign a separate consent form for chemotherapy that explains how the drug is given, as well as its risks and benefits.
Study Visits:
研究设计
- 研究类型
- Interventional
- 分配方式
- Non Randomized
- 干预模型
- Crossover
- 主要目的
- Other
- 盲法
- None
入排标准
- 年龄范围
- 18 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Patients must have histological evidence of a metastatic well differentiated or moderately differentiated mucinous appendiceal epithelial neoplasm (AEN).
- •Radiographic images demonstrating the presence of mucinous peritoneal carcinomatosis (PMP).
- •Patients must not be considered a candidate for a complete surgical cytoreductive surgery. This determination will be made through either discussion at MD Anderson peritoneal surface malignancy multidisciplinary review or consultation with MD Anderson peritoneal surgeon.
- •Eastern Cooperative Oncology Group (ECOG) Performance Status 0-
- •Age >/= 18 years old.
- •Patients must be able to understand and provide answers to the European Organisation for Research and Treatment of Cancer (EORTC) QLQ-C30/OV-28 QOL questionnaires in order to participate in the trial.
- •Adequate bone marrow function as evidenced by: Hemoglobin >/= 9.0 g/dl; Platelet >/= 75,000 cells/mm^3; Absolute neutrophil count >/= 1000/mm^
- •Women must not be pregnant or lactating. Women of childbearing potential must have a negative Beta-HCG serum pregnancy test and agree to refrain from breast-feeding, as specified in the informed consent given the unknown risk of teratogenicity of agents in the study. Patients of childbearing potential agree to use an effective form of contraception during chemotherapy and for 90 days following the last chemotherapy treatment.
- •Patients must agree to participate and be able to understand and provide informed consent to participate in the trial.
排除标准
- •Concurrent uncontrolled medical illness that is deemed by the investigator to have potential to interfere with the delivery of chemotherapy for a six month time period.
- •Patients who are receiving concurrent investigational therapy or who have received investigational therapy within 30 days of the first scheduled day of protocol treatment.
- •The presence of complete or partial bowel obstruction based upon clinical assessment.
- •Ongoing use of total parental nutrition.
- •The presence of a concurrent non-appendiceal metastatic cancer.
研究组 & 干预措施
Observation Arm
Patients observed for 6 months, then will receive chemotherapy for 6 months.
干预措施: Questionnaire (Behavioral)
Chemotherapy Group
Patients receive chemotherapy for 6 months, then observed for 6 months. The exact type of fluoropyrimidine-based chemotherapy is not mandated and final treatment decisions will be left to the medical oncologist who is administering the chemotherapy. All chemotherapy adjustments will be done by the treating medical oncologist according to standard of care.
干预措施: Questionnaire (Behavioral)
结局指标
主要结局
Tumor Growth Rate
时间窗: 6 months
Primary objective is to determine if difference in tumor growth rate for each patient, as measured by mpRECIST, between observation and systemic chemotherapy periods is ≥5%. Growth rate determined as the percent reduction from the start of the period to the 6 month measurement in that period.
次要结局
未报告次要终点