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.
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.
Study Type
INTERVENTIONAL
Purpose
TREATMENT
Masking
NONE
Enrollment
100
Peking University Cancer Hospital
Beijing, Beijing Municipality, China
RECRUITINGThe cycle of neoadjuvant chemotherapy
The cycle of neoadjuvant chemotherapy means the maximal cycle of effective neoadjuvant chemotherapy. The effective means no disease progress by image diagnosis
Time frame: 18months
The clinical response rate
The clinical response is evaluated by CT/MRI according to the Response Evaluation Criteria In Solid Tumors (RECIST)1.1
Time frame: 18 months
The completion rate of perioperative chemotherapy
The completion rate of perioperative chemotherapy means the patient completed the 8 cycles of perioperative chemotherapy as planned (n cycles of neoadjuvant chemotherapy and 8-n cycles of adjuvant chemotherapy)
Time frame: 18 months
The progressive disease rate
The progressive disease during neoadjuvant chemotherapy with shared decision making is is evaluated by CT/MRI according to the Response Evaluation Criteria In Solid Tumors (RECIST)1.1
Time frame: 18 months
The pathological response
The pathological response during neoadjuvant chemotherapy with shared decision making is evaluated according to the tumor regression grade of NCCN guideline.
Time frame: 18 months
The pathological complete response
The pathological complete response is defined as ypT0N0M0
Time frame: 18months
The adverse event of chemotherapy
The adverse event of chemotherapy is evaluated and recorded according to the Common Terminology Criteria for Adverse Events (CTCAE) v.3
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SOX: Oxaliplatin 130mg/m2,iv.,d1; S-1 60mg,po.,Bid,d1-14; Repeat every 21 days for 8-n courses.(0\<n\<8)
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
Time frame: 18 months
Surgical morbidity
Surgical morbidity is defined as the events which occurs with-in postoperative 30 days, extension of hospitalization and re-hospitalization. It is necessary to evaluate the complication and if it occurs during the hospitalization, it is required to record complication name, date of on-set (postoperatively), grade on Clavien-Dindo Classification and treatment for complication.
Time frame: 18 months
The 3-year progression-free survival
In terms of locally advanced gastric cancer, to evaluate the progression-free survival rate in gastrectomy with D2 lymph node dissection at postoperative 3 years
Time frame: 48months
The cTNM,ycTNM,ypTNM stage
The cTNM stage, ycTNM stage and ypTNM stage is defined according to the 8th TNM stage.
Time frame: 60months
The decisional conflicts
The decisional conflicts is evaluated by Decisional Conflict Scale
Time frame: 12months
The decisional regrets
The decisional regrets is evaluated by Decision Regret Scale
Time frame: 12months
The involvement of patients during the shared decision making
The involvement of patients during the shared decision making is evaluated by MAPPIN'SDM questionnaire
Time frame: 12months