CTRI/2024/04/065785尚未招募2 期
A phase II Randomized controlled trial comparing short-course radiation and chemotherapy with or without intraperitoneal paclitaxel for locally advanced, non-metastatic signet-ring cell rectal cancers. - NI
试验速览
- 阶段
- 2 期
- 状态
- 尚未招募
研究概览
简要总结
暂无简介。
研究设计
- 研究类型
- Interventional
入排标准
入选标准
- •Ability to provide informed consent in English, Hindi or Marathi
- •Biopsy proven signet ring cell carcinoma of the rectum
- •Non-metastatic on conventional staging investigations that includes contrast enhanced computerized tomography of the chest and abdomen, and magnetic resonance imaging of the pelvis
- •Staged at least T3 or T4 with or without radiologically involved mesorectal or lateral pelvic lymph nodes
- •Planned for chemotherapy and radiation with curative treatment in the multi-disciplinary joint meeting
- •Performance status in the Eastern Cooperative Oncology group less than 2
- •Patient who can give informed consent for the study.
- •Patient does not have any contra indication storeceive chemotherapy
- •Adequate haematological, hepatic and renal function parameters
- •Women of child-bearing age should have a negative pregnancy test at the time of randomization and should be willing to use adequate contraception during the treatment phase of the trial.
排除标准
- •Metastatic disease on pretreatment imaging
- •Extra pelvic lymph nodal metastasis
- •Patients undergoing upfront definitive resection of primary tumour
- •History of abdominal tuberculosis, significant adhesions in abdomen secondary to previous laparotomy or any other benign pathology
- •Known hyper sensitivity against 5-FU, capecitabine, leucovorin, irinotecan
- •Known contra indications against 5-FU, leucovorin, capecitabine, irinotecan
- •Clinically significant active coronary heart disease, cardio myopathy or congestive heart failure, NYHA III-IV, LVEF less than 50 percent.
- •Baseline neuropathy greater than NCI Grade I
- •Chronic inflammatory bowel disease
- •Active pregnancy or breast feeding
- •History of cancer diagnosis in the past 5 years
研究者
相似试验
已完成
2 期
A phase II randomized controlled trial comparing perioperative mFOLFOXIRI with perioperative chemoradiotherapy for locally advanced rectal cancer.Rectal cancerJPRN-UMIN000018624Osaka Medical College Hospital34
尚未招募
2 期
A clinical trial comparing pulmonary complications in two routes of gastric conduit placement after esophagectomyCTRI/2024/02/062245AIIMS NEW DELHI
招募中
2 期
A randomized controlled phase 2 trial comparing the safety and usefulness of robot-assisted esophagectomy and thoracoscopicJPRN-jRCT1040220153Takeuchi Hiroya90
进行中（未招募）
1 期
A randomized comparative phase II trial evaluating the capacity of the dualcombination doravirine/raltegravir to maintain virological success in HIV-1infected patients with an HIV-RNA plasma viremia below 50 copies/mL under acurrent antiretroviral regimen.HIV-1 INFECTIONEUCTR2019-004195-19-ITCentre de Recherche et d’Etudes sur la Pathologie Tropical et le Sida (CREPATS)150
进行中（未招募）
1 期
A randomized comparative phase II trial evaluating the capacity of the dual combination doravirine/raltegravir to maintain virological success in HIV-1 infected patients with an HIV-RNA plasma viremia below 50 copies/mL under a current antiretroviral regimeEUCTR2019-004195-19-FRCentre de Recherche et d’Etudes sur la Pathologie Tropicale et le Sida (CREPATS)150