The Effect of Preoperative Chemoradiotherapy on Resectability for Locally Advanced ,Unresectable Gastric cancer-A Pilot study
试验速览
- 阶段
- 2/3 期
- 状态
- 尚未招募
- 发起方
- JIPMER
- 入组人数
- 36
- 试验地点
- 1
- 主要终点
- To asses the R0 [complete microscopic resection ]resection rate in patient with unresectable locally advanced gastric cancer in the setting of preoperative chemoradiotherapy
研究概览
简要总结
After obtaining ethical committee approval patient will be recruited according to the eligibility criteria and obtaining informed consent, To Assess the eligibility patient will undergo CECT-TAP and Diagnostic Laparoscopy to assess TNM staging and resectability , and found to be Locally advanced unresectable with no obvious metastasis will be included in study.
Patient will receive 3 cycles of preoperative FLOT or CAPOX followed by chemoradiotherapy and then same postoperative chemotherapy for 3 cycles after curative surgery . the chemoradiotherapy will be given 3-4 weeks after completion of chemotherapy.
After 4 weeks of neoadjuvant treatment patient will be assed with CECT , RECIST criteria for tumor resp[onse will be assess , if found responsive on imaging , patient will be asses with diagnostic laparoscopy and will be planned for surgery subtotal or total gastrectomy with D2 lymphadenectomy with minimum approach of D1+ resection , post surgery patient will receive chemotherapy with FLOT or CAPOX with curative [R0] or Palliative [R1] intent. If patient is unresectable then palliative chemotherapy will be given.
Clinical evaluation will be done in OPD visit for every 3- month for 1 year. CECT evaluation at 6 month and 1 year
研究设计
- 研究类型
- Interventional
- 分配方式
- Na
- 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
- •1.Histologically confirmed Adenocarcinoma, of the stomach or gastroesophageal junction [steiwert3], Stage 4b[Invasion of Adjacent structures] or bulky N2/N3 disease deemed inoperable by multidisplinary team[MDT] after staging with CECT or Pec-ct and D-laparoscopy.(inoperability criteria.
- •involvement of adjacent organs like pancreas, liver, spleen etc, lesion encroaching duodenum, non regional lymph nodes like paraaortic nodes, involvement of bile duct, involvement of bile duct, common hepatic artery, celiac trunk 2.Age 18 to 70 3.ECOG 0-1.
排除标准
- •1.Disease metastasis [M1] 2.Prior Chemotherapy or Radiotherapy for gastric cancer 3.Uncontrolled comorbidites [ cardiac ejection fraction less than 50 percent, severe COPD,s.
- •Creatinine more than 1.6mg/dl] 4.Pregnancy or Breast Feeding 5.Contraindication to radiotherapy [prior abdominal radiation, connective tissue disorder].
结局指标
主要结局
To asses the R0 [complete microscopic resection ]resection rate in patient with unresectable locally advanced gastric cancer in the setting of preoperative chemoradiotherapy
时间窗: This will be checked postoperatively by histopathology within some 1-2 week of surgery
[This will be check on the histopathology specimen retrieve post surgery]
时间窗: This will be checked postoperatively by histopathology within some 1-2 week of surgery
次要结局
- 1. To evaluate the Radiologiocal [after CTRT ] & pathological tumor response rate [post surgery]
- 2. To assess treatment compliance & toxicity profile(Patient will be assessed in weekly basis in OPD as they come of the next cycle & after completion of Chemotherapy & radiotherapy respectively in the respective OPD & in Surgery OPD in 4 weeks time period & will also be told to come in emergency if severe toxicity so developed SOS)
- 3.To assess event free survival, [events are local and/or regional recurrence or progression ,distant recurrence or death from any cause(it will be assessed in 6months & 1 year of respective sample collection)
研究者
Ashmita Rijal
Department of General Surgery