Clinical Trials Logo

Clinical Trial Summary

Gastric cancer is the fifth most common carcinoma in the world, and cancer-related deaths rank third. It is one of the main causes of death from cancer in Korea. The cure method for gastric cancer is radical resection, but in most patients, radical resection is impossible due to local infiltration or peripheral organ or distant metastasis. Many assisted chemotherapy has been studied to improve survival rate, and in East Asia, assisted chemotherapy after complete D2 resection is the standard treatment. In the West, on the other hand, preoperative chemotherapy and postoperative assisted chemotherapy are currently standard treatments. However, due to the limited effect of adjuvant chemotherapy, it has been reported that better clinical course can be improved by increasing anticancer intensity. In this context, a large number of prior chemotherapy have been attempted, and prior chemotherapy has several potential effects as follows. (1) Improvement of R0 resection rate due to reduced primary cancer size, (2) early treatment for micro metastasis, (3) evaluation of treatment response rate in patients with measurable lesions, and (4) unnecessary laparotomy can be avoided in patients with biologically aggressive diseases. Based on the efficacy of chemotherapy in the combination of docetaxel, fluoropyrimidine, and platinum in metastatic gastric cancer, the investigators conducted a preceding auxiliary anti-cancer clinical trial of docetaxel, capecitabine and cisplatin in advanced gastric cancer patients who could not be completely resected by surgery. DXP was performed 4-6 cycles before surgery with the recommended dose in phase 1-2. In a total of 49 patients, R0 resection was performed in 31 (63%), and among patients, R0 resection was improved in cases where resection was not possible due to local infiltration (71%) and in cases where para-aortic node metastasis was performed (73%). We have reported that docetaxel, oxaliplatin, and S-1 chemotherapy (DOS) as preoperative adjuvant therapy can be safely administered in combination with D2 gastrectomy and postoperative adjuvant therapy S-1 in potentially resectable local progressive gastric cancer patients. R0 resection was achieved in 97.6% of patients, and pathological complete remission was observed in 19.5%. Based on this, a phase 3 PRODIGY study was performed to evaluate the benefit of S-1 (CSC group) as a preoperative prior chemotherapy compared to S-1 (SC group) as a postoperative adjuvant therapy in gastric cancer of cT2/3N+ or cT4Nany stage, and 0.75% of the CSC group was administered HR. In the patient group undergoing surgery, the R0 resection rate was 95% in the CSC group and 84% in the SC group. In the CSC group, the pathological complete remission rate was 10.4%. Based on these results, a clinical trial of DOS as a preoperative chemotherapy was planned for progressive gastric cancer that could not be resected due to local progression or metastasis limited to remote lymph nodes. Primary goal: Evaluation of R0 resection rate in patients who underwent prior chemotherapy as a clinical trial. Secondary objective: safety evaluation, overall survival period, progression-free survival period, pathological complete remission rate, and investigation of biological markers.

Clinical Trial Description


Study Design

Related Conditions & MeSH terms

NCT number NCT05184803
Study type Interventional
Source Asan Medical Center
Status Not yet recruiting
Phase Phase 2
Start date February 1, 2022
Completion date December 31, 2022

See also
  Status Clinical Trial Phase
Active, not recruiting NCT03313700 - Clinical Outcomes of Robotic Versus Laparoscopic Distal Gastrectomy for Gastric Cancer N/A
Recruiting NCT03549494 - Evaluation of Ocoxin®-Viusid® in Advanced Stomach Cancer and Gastric Esophagogastric Junction Phase 2
Completed NCT00935779 - Ultra Structure Of Peritoneum At Electronic Microscopy In Control Subjects And Patients With Gastric Cancer N/A
Completed NCT00144378 - Irinotecan Versus Only Best Supportive Care for Gastric Cancer Phase 3
Completed NCT00290966 - Randomized Multicenter Study Comparing Docetaxel Plus Cisplatin and 5-FU to Cisplatin Plus 5-FU in Advanced Gastric Cancer Phase 2/Phase 3
Recruiting NCT03348150 - Gastrectomy + Cytoreductive Surgery + HIPEC for Gastric Cancer With Peritoneal Dissemination. Phase 3
Not yet recruiting NCT05180864 - Omentum Preservation Versus Complete Omentectomy in Gastrectomy for Gastric Cancer N/A
Recruiting NCT02969122 - Treatment Strategy for Stage IV Gastric Cancer With Positive Peritoneal Cytology as the Only Non-curable Factor N/A
Completed NCT01482299 - RAD001 in Advanced Gastric Cancer Who Failed Standard First-line Treatment With pS6 Ser 240/4 Expression Phase 2
Active, not recruiting NCT03153280 - Dose Escalation Study of Lithium With Oxaliplatin and Capecitabine in Advanced Oesophago-Gastric or Colorectal Cancer Phase 1
Recruiting NCT03760822 - Second-Line Chemotherapy With Ramucirumab +/- Paclitaxel in Elderly Advanced Gastric or Gastroesophageal Junction Cancer Patients Phase 2
Recruiting NCT00509964 - Second-Line Irinotecan vs. ILF for AGC Phase 2
Recruiting NCT04889859 - Impact of Biliopancreatic Limb Length on Diabetes Following Distal Gastrectomy N/A
Completed NCT03071237 - The Origin of Infrapyloric Artery
Completed NCT00142038 - Docetaxel and Capecitabine in Advanced Gastric Cancer Phase 2
Not yet recruiting NCT04056260 - ICG-NIR Guided Lymph Node Dissection in Gastric Cancer N/A
Recruiting NCT03065257 - Endoscopic Resection Multicenter Registry N/A
Recruiting NCT04744649 - Neoadjuvant Immunotherapy and Chemotherapy for Locally Advanced Esophagogastric Junction and Gastric Cancer Trial Phase 2
Recruiting NCT05007912 - Prospective Observational Study Comparing the Use of Circular (Orvil) and Linear Stapler for Intracorporeal Esophagojejunostomy
Not yet recruiting NCT04893252 - Vactosertib and Durvalumab in Gastric Cancer Phase 2