| General information |
| Database: | DB00441 |
| Objective: | reoperative chemotherapy with S1 plus cisplatin is considered to be acceptable as one of the standard treatment options for gastric cancer patients with extensive lymph node metastases in Japan. Addition of trastuzumab to chemotherapy is shown to be effective for human epidermal growth factor receptor 2positive advanced gastric cancer patients, and they have commenced a randomizedphase II trial in March 2015 to evaluate S1 plus cisplatin plus trastuzumab compared with S1 plus cisplatin alone in the neoadjuvant setting for human epidermal growth factor receptor 2positive gastric cancer patients with ELM, which are followed by adjuvant chemotherapy with S1 for 1 year. |
| Authors: | Kataoka K, et al |
| Title: | A randomizedphase II trial of systemic chemotherapy with and without trastuzumab followed by surgery in human epidermal growth factor receptor 2positive advanced gastric or esophagogastric junction adenocarcinoma with extensive lymph node metastasis: Japan Clinical Oncology Group study JCOG1301 (Trigger Study). |
| Journal: | Jpn J Clin Oncol. |
| Year: | 2015 |
| PMID: | 26355164 |
| Trial Design |
| Clinical Trial Id: | UMIN 000016920 |
| Agent: | trastuzumab
|
| Target: | Receptor proteintyrosine kinase erbB2
|
| Cancer Type: | gastric cancer |
| Cancer Subtype: | gastric adenocarcinoma |
| Therapy Type: | com |
| Therapeutic Combination Type: | 6 |
| Therapeutic Combination Content: | systemic chemotherapy with and without trastuzumab followed by surgery |
| Study Type: | A multiinstitutional twoarm open label randomizedphase II trial |
| Key Patients Feature: | 1.Histologically proven primary gastric adenocarcinoma.2.human epidermal growth factor receptor 2 positive (Immunohistochemistry (IHC) 3+ or IHC 2+ andISH +).3. Contrastenhanced abdominal computed tomography (CT)revealed at least one of the following:(i) PAN enlargement more than and equal to 1.0 cm in major axis between the uppermargin of the celiac artery and the upper border of the inferior mesenteric artery (No. 16a2/16b1)(ii) Bulky lymph nodes (more than and equal to 3 cm ¡Á 1 or more than and equal to 1.5 cm ¡Á 2 or more inmajor axis) along the celiac, splenic, common or proper hepatic arteries or the superior mesenteric vein(iii) T2-T4 disease with enlarged regional lymph node (more than and equal to 1.5 cmin minor axis)4. Contrastenhanced thoracic/abdominal/pelvic CT revealed nometastatic lesion other than lymph node metastasis.5. The macroscopic tumor type is neither Borrmann type 4 (linitisplastica) nor large (8 cm or more) type 36. No esophageal invasion or an invasion of 3 cm or less 7. No gastric stump cancer8. No prior chemotherapy, radiotherapy or endocrine therapy forany malignancies.9. No prior surgery for gastric carcinoma except bypass surgery andendoscopic resection for metachronous mucosal cancer10. A staging laparoscopy or laparotomy performed within 28 daysbefore registration revealed negative washing cytology and noperitoneal metastasis11. Aged 20-75 years old.12. Eastern Cooperative Oncology Group (ECOG) performance status of 0 or 1.13. Left ventricular ejection fraction more than and equal to 50% by ultrasound cardiography.14. Sufficient organ function.(i) Neutrophil more than and equal to 1500/mm3(ii) Hb more than and equal to 8.0 g/dl(iii) Platelets more than and equal to 100 000/mm3(iv) Total bilirubin less than and equal to 2.0 mg/dl(v) Aspartate aminotransferase less than and equal to 100 IU/L(vi) Alanine aminotransferase less than and equal to 100 IU/L(vii) Creatinine less than and equal to 1.3 mg/dl(viii) Creatinine clearance more than and equal to 60 ml/min/body15. Written informed consent. |
| Biomarker: | human epidermal growth factor receptor 2positive |
| Biomark Analysis: | pending |
| Control Group Info: | A: S1 plus cisplatin plus trastuzumab B: S1 plus cisplatin alone |
| Treatment Info: | to evaluate S1 plus cisplatin plus trastuzumab compared with S1 plus cisplatin alone in the neoadjuvant setting for human epidermal growth factor receptor 2positive gastric cancer patients with ELM, which are followed by adjuvant chemotherapy with S1 for 1 year. |
| Primary End Point: | overall survival |
| Secondary End Point: | progression free survival, response rate |
| Patients Number: | 130 |
| Trial Results |
| DLT_MTD: | NA |
| Objective Response Rate: | NA |
| Disease Control Rate: | NA |
| Median Time to Progression: | NA |
| Median PFS A vs. C: | NA |
| Median OS A vs. C: | NA |
| Adverse Event(agent arm): | NA |
| Conclusions: | NA |