Phase I Trial of Ultra-fractionated Adaptive Radiotherapy, Chemotherapy and Selective Omission of Surgery for Locally Advanced Rectal Cancer
试验速览
- 阶段
- 1 期
- 状态
- 进行中（未招募）
- 入组人数
- 27
- 试验地点
- 2
- 主要终点
- To determine the maximal tolerated dose (MTD) of dose-escalated hypofractionated RT.
研究概览
简要总结
The rationale of this clinical trial is to assess the feasibility of selective non-operative management for locally advanced rectal cancer using dose-escalated ultra-fractionated short course radiation therapy interdigitated with chemotherapy. We believe delivering short course radiotherapy over a prolonged interval, at escalated doses and with concurrent chemotherapy may be feasible and allow for improved clinical response.
详细描述
To determine the maximal tolerated dose (MTD) of dose-escalated hypofractionated adaptive RT, in patients with locally advanced rectal cancer treated with RT, FOLFOX (5-FU, oxaliplatin, leucovorin) or CAPOX (capecitabine, oxaliplatin) chemotherapy and selective omission of surgery.
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
- All
- 接受健康志愿者
- 否
入选标准
- •At least 18 years of age. Both men and women and members of all races and ethnic groups will be included.
- •Willing and able to provide written informed consent
- •Pathologic diagnosis of rectal adenocarcinoma
- •T3-4 and/or N+ disease per AJCC 8th edition
- •No prior treatment for rectal adenocarcinoma
- •Eastern Cooperative Group (ECOG) performance status of 0-
- •Laboratory values supporting acceptable organ and marrow function within 30 days of eligibility confirmation. Defined as follows:
- •WBC ≥ 3,000/mL;
- •ANC WBC ≥ 1,000/mL;
- •PLT ≥ 75,000/mL;
- •T Bili ≤ 1.5 x upper limit of normal (ULN);
- •AST/ALT ≤ 2.5 x ULN;
- •Creatinine not above ULN, or creatinine clearance >50 mL/min/1.73 m^2 for participants with creatinine levels above institutional normal.
- •All men, as well as women of child-bearing potential must agree to use adequate contraception (hormonal or barrier method of birth control; abstinence) starting with the first dose of study therapy through 90 days after the last dose of study drugs. Should a woman become pregnant or suspect she is pregnant while participating in this study, she should inform her treating physician immediately.
- •A female of child-bearing potential is any woman (regardless of sexual orientation, marital status, having undergone a tubal ligation, or remaining celibate by choice) who meets the following criteria:
- •Has not undergone a hysterectomy or bilateral oophorectomy; or
- •Has not been naturally postmenopausal for at least 12 consecutive months (i.e., has had menses at any time in the preceding 12 consecutive months).
排除标准
- •Distant nodal disease (retroperitoneal nodes) including inguinal nodes, or any metastatic disease by CT.
- •Prior RT to the pelvis.
- •Uncontrolled comorbid illness or condition including congestive heart failure, unstable angina, cardiac arrhythmia, or psychiatric illness that would limit compliance with the study requirements.
- •Psychiatric illness/social situations that would limit consenting and compliance with study requirements.
- •Participants who are pregnant or nursing due to the potential for congenital abnormalities and the potential of this regimen to harm nursing infants
研究组 & 干预措施
Phase I Dose Cohorts
DOSE LEVEL 1 : 30 Gy (tumor)/ 25 Gy (pelvis)
DOSE LEVEL 2 : 35 Gy (tumor)/ 25 Gy (pelvis)
DOSE LEVEL 3 : 40 Gy (tumor)/ 25 Gy (pelvis)
干预措施: Ultrafractionated radiotherapy for rectal cancer (Radiation)
结局指标
主要结局
To determine the maximal tolerated dose (MTD) of dose-escalated hypofractionated RT.
时间窗: 0 to 60 days post radiation therapy
The MTD will be based upon toxicity, which will be assessed according to the NCI's CTCAE v5.0 toxicity criteria. Dose limiting toxicities will include any of the following Grade 3+ GI toxicities.
次要结局
- To evaluate the rate of clinical complete and near complete response to radiation and chemotherapy.(1 year)
- To determine the organ preservation rate at 1 year after radiotherapy and FOLFOX or CAPOX chemotherapy.(1 year)
- To evaluate local regional recurrence, defined as the time between date of therapy initiation and date of local progression.(1 year)
- To evaluate the rate of distant failure, defined as development of disease outside of the pelvis.(1 year)
- To evaluate disease-free survival (DFS), defined as the time between date of therapy completion the first date of documented disease progression or death.(1 year)
- For patients undergoing surgery, to evaluate the rate of R0 resection, defined as a negative surgical margin at time of total mesorectal excision.(1 year)
研究者
Nina Sanford
Assistant Professor
University of Texas Southwestern Medical Center