The Radiation Oncology-Biology Integration Network (ROBIN) Molecular Characterization Trial (MCT) of Standard Short Course Radiotherapy for Rectal Cancer.
试验速览
- 阶段
- 不适用
- 状态
- 招募中
- 入组人数
- 25
- 试验地点
- 8
- 主要终点
- Number of tissue biopsies obtained from treated patients
研究概览
简要总结
This trial (molecular characterization trial) focuses on rectal cancer, a common cancer that is treated with radiotherapy (RT) as standard of care and represents a setting in which to study the effects of RT on the immune system.
详细描述
The study aims to test the hypothesis that the radiation therapy will assist in targeting the rectal cancer by mounting a robust immune response against the rectal cancer.
研究设计
- 研究类型
- Interventional
- 分配方式
- Na
- 干预模型
- Single Group
- 主要目的
- Basic Science
- 盲法
- None
入排标准
- 年龄范围
- 18 Years 至 90 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Histologically confirmed diagnosis of adenocarcinoma of the rectum
- •Age ≥ 18 years
- •ECOG performance status 0-1
- •cT2-T3N0 or cT1-3N1 or cT4 or cN2
- •Rectal cancer amenable to total mesorectal excision
- •No evidence of distant metastases
- •No prior pelvic radiation therapy
- •No prior chemotherapy or surgery for rectal cancer
- •Total neoadjuvant therapy (short course radiotherapy followed by consolidative chemotherapy) is allowed
- •No infections requiring systemic antibiotic treatment
- •Hgb >8.0 gm/dL, PLT > 150,000/mm3, total bilirubin ≤ 1.5x upper limit of normal, AST ≤ upper limit of normal, ALT ≤ 3x upper limit of normal
- •Patients must read, agree to, and sign a statement of informed consent prior to participation in this study. Patients who do not read or understand English or eligible but must have the consent form read to them in its entirety by an official translator. Informed consent for non-literate or non-English speaking patients may not be obtained by using a relative or a member of the patient's clinical team as a translator.
- •Female participants or reproductive potential, defined as not surgically sterilized and between menarche and 1 year post menopause, must have a negative serum pregnancy test within 4 weeks prior to initiation of study treatment.
- •Women with childbearing potential who are negative for pregnancy (urine or blood) and who agree to use effective contraceptive methods. A woman of childbearing potential is defined by one who is biologically capable of becoming pregnant. Reliable contraception should be used from trial screening and must be continued throughout the study.
排除标准
- •Recurrent rectal cancer
- •Primary unresectable rectal cancer is defined as a primary rectal tumor which, on the basis of either physical exam or pelvic MRI, is deemed to be adherent or fixed to adjacent pelvic structures (en bloc resection will not be achieved with negative margins).
- •Patients who have received prior pelvic radiotherapy
- •Patients with prior allogenic stem cell or solid organ transplantation.
- •Patients receiving treatment with systemic immunosuppressive medication (including, but not limited to, corticosteroids, cyclophosphamide, azathioprine, methotrexate, thalidomide, and antitumor necrosis factor-α agents) administered at >10 mg/day prednisone or equivalent within 2 weeks prior to initiation of study treatment.
- •Patients with any other concurrent medical or psychiatric condition or disease which, in the investigator's judgment would make them inappropriate candidates for entry into this study
- •Patients receiving other anticancer or experimental therapy. No other experimental therapies (including chemotherapy, radiation, hormonal treatment, antibody therapy, immunotherapy, gene therapy, vaccine therapy, angiogenesis inhibitors, matrix metalloprotease inhibitors, thalidomide, anti-VEGF/Flk-1 monoclonal antibody, or other experimental drugs) of any kind are permitted while the patient is receiving study treatment.
- •Women who are pregnant or breastfeeding. Women of childbearing potential who are unwilling or unable to use an acceptable method of birth control to avoid pregnancy for the entire study period and for up to four weeks after the study.
结局指标
主要结局
Number of tissue biopsies obtained from treated patients
时间窗: Week 6
To conduct a multi-centric prospective clinical trial of standard short course RT in the neoadjuvant setting of rectal cancer (MCT), with harmonized tissue acquisition and immune characterization across seven international centers, and assess quality of life during MCT and pathological response at surgery.
Number of research specimens obtained before RT.
时间窗: Baseline
To obtain a unique set of biospecimens of optimal quality for cutting-edge imaging and multi-omics analyses at the single cell level that are spatially integrated, obtained longitudinally before and after RT and at the time of surgery.
Number of research specimens obtained after RT.
时间窗: Week 1
To obtain a unique set of biospecimens of optimal quality for cutting-edge imaging and multi-omics analyses at the single cell level that are spatially integrated, obtained longitudinally before and after RT and at the time of surgery.
Number of research specimens obtained at the time of surgery.
时间窗: Week 6
To obtain a unique set of biospecimens of optimal quality for cutting-edge imaging and multi-omics analyses at the single cell level that are spatially integrated, obtained longitudinally before and after RT and at the time of surgery.
次要结局
- Changes in functional diffusion patterns from pre-treatment and post-treatment MRI will be measured.(Baseline, Week 1)
- Changes in tumor morphology from pre-treatment and post-treatment MRI will be measured.(Baseline, Week 1)
- Changes in tumor texture from pre-treatment and post-treatment CT will be measured.(Baseline, Week 1)
- Changes in enhancement kinetics from pre-treatment and post-treatment MRI will be measured.(Baseline, Week 1)
- Changes in Cellular stress (quantification of reactive Oxygen species (ROS))(Baseline, Week 1, Week 6)
- Changes in tumor morphology from pre-treatment and post-treatment CT will be measured.(Baseline, Week 1)
- Changes in tumor texture from pre-treatment and post-treatment MRI will be measured.(Baseline, Week 1)
- Changes in enhancement kinetics from pre-treatment and post-treatment CT will be measured.(Baseline, Week 1)
- Changes in functional diffusion patterns from pre-treatment and post-treatment CT will be measured.(Baseline, Week 1)
- Changes in immunological fitness related to radio-responsiveness and their associated pathological response will be measured by quantifying senescence using vital dye DDAO.(Baseline, Week 1, Week 6)
- Changes in immunological fitness related to radio-responsiveness and their associated pathological response will be measured by quantifying aging using p16 protein expression as a marker.(Baseline, Week 1, Week 6)
- Changes in immunological fitness related to radio-responsiveness and their associated pathological response will be measured by quantifying gamma-H2aX (aging).(Baseline, Week 1, Week 6)
- Comparing levels of cell death related to radio responsiveness will be measured by quantifying cleaved caspase-3(Baseline, Week 1, Week 6)