JPRN-jRCTs031180230已完成2 期
JCOG1310: A phase II/III randomized controlled trial comparing perioperative versus postoperative chemotherapy with mFOLFOX6 for lower rectal cancer with suspected lateral pelvic node metastasis - PRECIOUS trial
Ohue Masayuki0 个研究点目标入组 48 人开始时间: 2019年3月11日最近更新:
适应症
试验速览
- 阶段
- 2 期
- 状态
- 已完成
- 发起方
- 入组人数
- 48
研究概览
简要总结
This study had a planned accrual period of 7 years but was terminated due to poor accrual of patients 4 years after the start of enrollment. The number of final enrolled patients was 48, which is 14.5% of the planned 330. Therefore, the statistical power of this study is very low and some definite conclusions cannot be drawn from this study.
研究设计
- 研究类型
- Interventional
入排标准
- 年龄范围
- >= 20age old 至 <= 74age old（—）
- 性别
- All
入选标准
- •1. Pathologically proven adenocarcinoma or adenosquamous carcinoma
- •2. Primary tumor located at Upper rectum, Lower rectum, and Anal canal
- •3. The lower border of the tumor located between the peritoneal reflection and the anal verge
- •4. cT2, cT3, and cT4 tumor on contrast-enhanced CT or MRI, except T4b tumor invading the trigone of bladder, urethra, or sacrum
- •5. Lateral lymph nodes with 10mm or more in short axis diameter on contrast-enhanced CT or MRI data of 5mm-thickness slices (cN3)
- •6. No distant metastasis on contrast-enhanced CT or MRI (cM0)
- •7. Aged 20 to 74 years old
- •8. Eastern Cooperative Oncology Group (ECOG) performance status of 0 or 1
- •9. No prior chemotherapy or treatment such as rectal resection, pelvic lymph node dissection, or pelvic irradiation for any malignancies
- •10. No other colorectal carcinoma, except cTis or cT1a
- •11. Adequate organ function as evidenced by the following laboratory studies within 14 days prior to enrollment
- •1) Neutrophil count >= 1,500 /mm3
- •2) Platelet count >= 100,000 /mm3
- •3) T.Bil =< 2.0 mg/dL
- •4) AST =< 100 IU/L
- •5) ALT =< 100 IU/L
- •6) Cr =< 1.5 mg/dL
- •12. Open surgery or laparoscopic surgery will be performed
- •13. Written informed consent
排除标准
- •1) Synchronous or metachronous (within 5 years) malignancies other than carcinoma in situ or mucosal carcinoma
- •2) Infectious disease to be treated
- •3) Positive for HBs antigen
- •4) Body temperature >= 38 degrees Celsius
- •5) Women during pregnancy, possible pregnancy or breast-feeding
- •6) Severe mental disease
- •7) Currently treated with systemic steroids or immunosuppressive agents
- •8) Interstitial pneumonia, pulmonary fibrosis, or severe emphysema on chest CT
- •9) Uncontrollable diabetes mellitus or routine administration of insulin
- •10) Unstable angina pectoris or previous myocardial infarction within the past 6 months
研究者
相似试验
招募中
3 期
JCOG2207: A phase III randomized controlled trial comparing total mesorectal excision and lateral lymph node dissection plus adjuvant chemotherapy with total neoadjuvant therapy followed by total mesorectal excision and selective lateral lymph node dissection for the patients with locoregionally advanced low rectal cancerRectal cancerJPRN-jRCTs031230415OHUE Masayuki420
已完成
2 期
JCOG1207: A randomized controlled phase II/III study comparing EBD combined with steroid versus RIC combined with steroid for refractory anastomotic stricture after esophagectomyRefractory anastomotic stricture after surgical resection for esophageal cancerJPRN-jRCTs031180177MUTO Manabu130
进行中（未招募）
3 期
JCOG1314: A randomized controlled phase III study comparing docetaxel, CDDP and 5-FU with CDDP and 5-FU in patients with metastatic or recurrent esophageal canceresophageal cancerJPRN-jRCTs031180143TSUBOSA Yasuhiro240
招募中
3 期
JCOG2107E: A randomized phase III trial comparing etoposide plus carboplatin combination therapy with/without durvalumab (MEDI4736) for advanced neuroendocrine carcinoma of the digestive systemneuroendocrine carcinoma of the digestive systemJPRN-jRCT2031230456Morizane Chigusa74
招募中
2 期
JCOG2203: A randomized controlled phase II/III trial of neoadjuvant chemotherapy for Japanese patients with esophagogastric junction adenocarcinomaJPRN-jRCTs031230182KUROKAWA Yukinori460