NCT03413514

Real World Evidence for the Cycle of Neoadjuvant Chemotherapy in Gastric Cancer With Shared Decision Making

A Non-Randomized,Single Center Study to Investigate the Real World Evidence for the Maximal Cycle of Effective Neoadjuvant Chemotherapy in Gastric Cancer With Shared Decision Making

• Status: Unknown
• Phase: N/A
• Study type: Interventional
• Enrollment: 100 (estimated)
• Sponsor: Peking University · Academic / Other
• Sex: All
• Age: —
• Healthy volunteers: Not accepted

Summary

The purpose of the study is to evaluate the maximal cycle of effective neoadjuvant chemotherapy for resectable gastric cancer, to determine what is the best cycle of neoadjuvant chemotherapy for the patients who receive neoadjuvant chemotherapy.

Detailed description

The study is a non-randomized clinical trial. The protocol has been approved by the Ethics Committee of Beijing Cancer Hospital. MRI and enhanced CT are used to evaluate the clinical response of the tumor. The primary endpoint is the maximal cycle of effective neoadjuvant chemotherapy for resectable gastric cancer.

Conditions

• Gastric Cancer

Interventions

Type	Name	Description
DRUG	NACT	SOX: Oxaliplatin 130mg/m2,iv.,d1; S-1 60mg,po.,Bid,d1-14; Repeat every 21 days for n courses.(0\<n\<8)
PROCEDURE	SDM	Making the decision about the cycle of neoadjuvant chemotherapy with shared decision making
PROCEDURE	Surgery	Radical surgery with D2 lymph node dissection
DRUG	ACT	SOX: Oxaliplatin 130mg/m2,iv.,d1; S-1 60mg,po.,Bid,d1-14; Repeat every 21 days for 8-n courses.(0\<n\<8)
OTHER	Questionnaire	MAPPIN'SDM questionnaire, the control performance card, the care questionnaire, the decisional conflict questionnaire, the decisional regret questionnaire, the questionnaire of the reason for stopping neoadjuvant chemotherapy

Timeline

• Start date: 2018-01-03
• Primary completion: 2019-01-03
• Completion: 2023-01-03
• First posted: 2018-01-29
• Last updated: 2018-01-29

Locations

1 site across 1 country: China