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.
试验速览
- 阶段
- 2 期
- 状态
- 尚未招募
- 入组人数
- 206
- 试验地点
- 1
- 主要终点
- 1-year DFS reduction in treatment failures defined as a composite of default, progressions, inoperability, R2 resections, recurrences, and death due to any cause
研究概览
简要总结
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.
Colorectal cancer is a significant global health problem, ranking as the third most common cancer worldwide and the second leading cause of cancer-related deaths. In India, there is a concerning prevalence of a specific type of colorectal cancer called signet-ring cell adenocarcinoma, which makes up about 15% of rectal cancer cases. This is in stark contrast to the rest of the world where it’s less than 5%. Signet-ring cell cancers (SRCC) are particularly aggressive and don’t respond well to standard treatments, leading to poor survival rates.
Recent progress has been made in treating locally advanced rectal cancers (LARC). A new approach called total neoadjuvant therapy has improved disease-free survival by 7%. However, these advances don’t apply to SRCC cases because this type of cancer is unique in its behavior and aggressiveness. Most treatment failures in these cases were due to the cancer spreading to the peritoneum, which is the thin layer of tissue that lines the abdomen. This is a problem specific to signet-ring cell cancers.
To tackle this challenge, our upcoming study will compare the current standard of care, which involves short-course radiation and intravenous (IV) chemotherapy, with a new approach. This new approach includes short-course radiation, IV chemotherapy, and intraperitoneal (IP) chemotherapy for locally advanced, non-metastatic signet-ring cell rectal cancers. Our primary goal is to reduce treatment failures and improve disease-free survival, with a special focus on addressing the high rates of peritoneal failures often seen in SRCC.
The IP chemotherapy will deliver chemotherapy directly inside the abdomen by placing a device underneath the skin of the abdomen with tubes within the abdomen. Eligible patients that consent to the study will be randomly allocated to receive the standard of care treatment of radiation and chemotherapy versus standard of care along with IP chemotherapy.
We will be looking for reduction in disease related events at the end of one year and expect that the addition of IP chemotherapy will reduce treatment failures (disease progression, recurrence, or deaths) by an additional 20%.
In summary, our research question centers around whether adding neoadjuvant IP chemotherapy to the existing treatment of radiation and IV chemotherapy can benefit patients with locally advanced signet-ring cell rectal cancers. We recognize the unique challenges posed by SRCC and aim to create a tailored treatment approach to improve the outcomes for this highly aggressive variant of rectal cancer.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 盲法
- None
入排标准
- 年龄范围
- 18.00 Year(s) 至 70.00 Year(s)（—）
- 性别
- All
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.
结局指标
主要结局
1-year DFS reduction in treatment failures defined as a composite of default, progressions, inoperability, R2 resections, recurrences, and death due to any cause
时间窗: 1-year
次要结局
- 1)Treatment toxicity on the CTCAE version 5.0(2)2-year overall survival)
研究者
DrAvanish Saklani
tata memorial hospital dr ernest borges marg parel mumbai