NCT04827732终止不适用
Hypofractionated Pencil-Beam Scanning Intensity-modulated Proton Therapy (IMPT) in the Reirradiation of Locoregionally Recurrent Rectal Cancer - IMPARC
适应症
试验速览
- 阶段
- 不适用
- 状态
- 终止
- 入组人数
- 15
- 试验地点
- 2
- 主要终点
- Maximum Tolerated Dose (MTD) of Reirradiation Using Hypofractionated IMPT
研究概览
简要总结
The purpose of this trial is to determine the maximum tolerated dose (MTD) of hypofractionated IMPT for the reirradiation of locoregionally recurrent rectal cancer.
研究设计
- 研究类型
- Interventional
- 分配方式
- Non Randomized
- 干预模型
- Sequential
- 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
- •History of biopsy-proven adenocarcinoma of the rectum, anus or rectosigmoid junction of any stage now with recurrent disease in the pelvis
- •One prior course of radiation therapy to the pelvis for rectal cancer
- •ECOG performance status 0-2
- •At least 18 years of age
- •Women of childbearing potential and men must agree to use adequate contraception (hormonal or barrier method of birth control, abstinence) prior to study entry and for the duration of study participation. Should a woman become pregnant or suspect she is pregnant while participating in this study, she must inform her treating physician immediately.
- •Able to understand and willing to sign an IRB-approved written informed consent document.
排除标准
- •Patients with pre-existing radiosensitizing conditions, such as connective tissue disorders (i.e. lupus, scleroderma) and genetic mutations (i.e. ataxia-telangiectasia)
- •A history of other malignancy with the exception of malignancies for which all treatment was completed at least 2 years before registration and the patient has no evidence of disease, basal cell or squamous cell carcinoma of the skin that were treated with local resection only, or carcinoma in situ of the cervix. Patients with history of prostate cancer treated without radiotherapy and no evidence of disease are eligible
- •More than one prior course of radiation to the pelvis for rectal cancer
- •Prior radiation to the pelvis for disease other than rectal cancer
- •Tumor in the rectum/colon requiring radiation therapy to the full circumference of the rectum/colon.
- •Current treatment with any investigational agents.
- •Uncontrolled intercurrent illness including, but not limited to, ongoing or active infection, or unstable angina pectoris
- •Pregnant and/or breastfeeding. Women of childbearing potential must have a negative urine or serum pregnancy test within 14 days of study entry.
结局指标
主要结局
Maximum Tolerated Dose (MTD) of Reirradiation Using Hypofractionated IMPT
时间窗: From start of treatment through 6 months
* MTD is defined as the dose associated with a 35% probability of dose-limiting toxicity (DLT). * DLT is defined as any toxicity listed below that occurs within 6 months from start of treatment and is considered possibly, probably, or definitely related to proton reirradiation: * Any grade 5 toxicities * Any grade 4-5 GI toxicities * Bowel obstruction * Grade 3-5: diarrhea; anal, colonic, or bowel ulcers; bladder perforation; any fistula formations; peripheral motor/sensory neuropathy of the pelvis above baseline; osteonecrosis/soft tissue necrosis; radiation dermatitis; hematuria; hematochezia; bowel/pelvic hemorrhage; reproductive tract toxicity * Toxicity will be graded using CTCAE v5
次要结局
- Median Change in Quality of Life (QoL) Score as Measured by The European Organisation for Research and Treatment of Cancer Quality of Life Questionnaire Core 30 (EORTC QLQ-C30)(Assessed at pre-treatment (baseline), 1-2 weeks, 3 months, 6 months, 9 months, and 12 months post-treatment)
- Median Overall Survival (OS)(Through completion of follow-up (full range 4.4 months to 13.87 months))
- Median Progression-free Survival (PFS)(Through completion of follow-up (full range 1.81 months-13.87 months))
- Clinical Complete Response Rate(Within 6 weeks to 3 months post-completion of radiation therapy (range 7-14 weeks))
- Median Freedom From Locoregional Progression (FFLP)(Through completion of follow-up (full range 1.81 months-13.87 months))
- Median Change in Quality of Life (QoL) Score as Measured by the European Organisation for Research and Treatment of Cancer Quality of Life Questionnaire Colorectal Cancer Module 29 (EORTC QLQ-CR29)(Assessed at pre-treatment (baseline), 1-2 weeks, 3 months, 6 months, 9 months, and 12 months post-treatment)
- Median Change in Quality of Life (QoL) Score as Measured by the by the European Organisation for Research and Treatment of Cancer Quality of Life Questionnaire Colorectal Cancer Module 29 (EORTC QLQ-CR29)(Assessed at pre-treatment (baseline), 1-2 weeks, 3 months, 6 months, 9 months, and 12 months post-treatment)
- Frequency of Treatment-related Acute Adverse Events as Measured by CTCAE v 5.0(From start of treatment through 3 months after completion of radiation therapy (estimated to be 3 months and 1 week))
- Frequency of Treatment-related Late Adverse Events as Measured by CTCAE v 5.0(From 3 month post-completion of radiation therapy to 12 months post-completion of radiation therapy)
研究者
研究点 (2)
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