SHORT: SHOrt Course Radiation and TASOX (TAS102 Plus Oxaliplatin) Chemotherapy in Operable Rectal Cancer, a Phase II Trial
试验速览
- 阶段
- 2 期
- 状态
- 已完成
- 入组人数
- 13
- 试验地点
- 4
- 主要终点
- Neoadjuvant Response (NAR) Score
研究概览
简要总结
TASOX can be safely and efficaciously delivered after short course radiation, resulting in significant pathologic downstaging, allowing for an R0 pelvic resection, and providing local control in appropriately selected stage II/III rectal cancer patients treated with contemporary TME-based surgery.
详细描述
In this phase II study patients will be treated with short-course preoperative irradiation (25 Gy in five fractions of 5 Gy) followed by 6 (six) 2-week cycles of TASOX followed by total mesorectal excision (TME) for patients with resectable rectal cancer (clinical T3c/dN0, T3c/dN1, T2N1). Eligible study subjects include adults who are candidates for curative intent sphincter-sparing surgery and lack high risk features such as tumor encroaching upon the mesorectal-fascia or low tumors who need an Abdominal-Perineal Resection (APR).
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
- •Age of at least 18 years.
- •Newly diagnosis of rectal adenocarcinoma.
- •ECOG Performance Status (PS): 0, 1 or
- •Candidate for sphincter-sparing surgical resection prior to initiation of neoadjuvant therapy according to the primary surgeon.
- •Clinical Stage: T1/N1, T2/N1, T3/N1, T3c/dN
- •Absence of metastatic disease. Clinical staging is based on physical exam by the primary surgeon, CT scan of the chest/abdomen, and pelvic MRI.
- •Node positivity determination: Entry criteria nodes will be measured in short-axis diameter and for the purposes of study entry will be considered positive if 8 mm or greater in short axis.
- •Radiographic N2 status is estimated as: 4 or more nodes that measure 8mm or more in short-axis.
- •Radiographic N1 status is estimated as: fewer than 4 lymph nodes that measure 8 mm or greater in short axis but 1 or more lymph nodes that measure 8 mm or greater.
- •Nodal Metastatic Disease: nodal stations considered suspicious for metastatic disease (M1) for rectal cancer are common iliac, external iliac and inguinal nodes.
- •No evidence of tumor that is adherent to the mesorectal fascia and the ability to perform a curative intent sphincter-sparing TME resection at diagnosis. See exclusion criterion 4
- •The following laboratory values obtained ≤ 28 days prior to registration.
- •Platelet count ≥ 100,000/mm^3
- •Hemoglobin > 8.0 g/dL
- •Total bilirubin ≤ 1.5 x upper limit of normal (ULN)
- •SGOT (AST) ≤ 3 x ULN
- •SGPT (ALT) ≤ 3 x ULN
- •Creatinine ≤1.5 x ULN
- •Negative pregnancy test done ≤ 7 days prior to registration, for women of childbearing potential only.
- •A patient of child-bearing potential is willing to employ adequate contraception. It includes any of the followings: abstinence, oral contraceptives, implantable hormonal contraceptives, or double barrier method (diaphragm plus condom). See exclusion criterion 8
- •Provide informed written consent.
- •Willing to return to enrolling medical site for all study assessments.
排除标准
- •Clinical T4 tumors.
- •Clinical N2 disease estimated as four or more lymph nodes that are ≥8 mm.
- •Primary surgeon indicates need for abdominoperineal (APR) at baseline.
- •Evidence that the tumor is adherent to or invading the mesorectal fascia on imaging studies such that the surgeon would not be able to perform an R0 resection (one with negative margins).
- •Distance of the Tumor from the Mesorectal Fascia:
- •Patients with tumors with a distance of 1mm or less from the mesorectal fascia reflection have threatened radial margins and are ineligible.
- •Tumor is causing symptomatic bowel obstruction or patients who have had a temporary diverting ostomy are ineligible.
- •Chemotherapy within 5 years prior to registration. (Hormonal therapy is allowable if the disease free interval is ≥ 5 years.)
- •Any prior pelvic radiation.
- •Any of the following because this study involves an agent that has known genotoxic, mutagenic and teratogenic effects:
- •Pregnant women
- •Nursing women
- •Men or women of childbearing potential who are unwilling to employ adequate contraception
- •Co-morbid illnesses or other concurrent disease which, in the judgment of the treating investigator obtaining informed consent, would make the patient inappropriate for entry into this study or interfere significantly with the proper assessment of safety and toxicity of the prescribed regimens.
研究组 & 干预措施
TAS102 plus Oxaliplatin
Oxaliplatin 85mg/m2 IV over 2 hours and TAS-102 (35 mg/m2/dose) orally BID
干预措施: Oxaliplatin (Drug)
TAS102 plus Oxaliplatin
Oxaliplatin 85mg/m2 IV over 2 hours and TAS-102 (35 mg/m2/dose) orally BID
干预措施: TAS 102 (Drug)
结局指标
主要结局
Neoadjuvant Response (NAR) Score
时间窗: Through study completion, an average of 6 months
Determine whether pre-operative short-course radiation therapy (SRT) and 6 cycles of TASOX offers condensed radiation and total neoadjuvant therapy for intermediate risk rectal cancer. Measurement of efficacy is the NAR score, where the required elements of the NAR score are: clinical tumor stage (cT), pathologic tumor stage (pT), pathological nodal stage (pN). For patients with a cCR who opted for non-operative management, for the purposes of the NAR score, those patients were assigned a pT0 and pN0 score if they did not experience tumor regrowth or require subsequent TME surgical resection during the time of the study. The NAR score ranges from 0-100, where lower NAR scores are considered favorable as opposed to higher scores which would indicate a worse prognosis. NAR calculation as follows: NAR=\[5 pN- 3(cT-pT)+12\]\^2/9.61
次要结局
- Safety and Tolerability(Through study completion, an average of 6 months)