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

Study Overview
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Brief Summary
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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
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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.

Official Title
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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

Conditions
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Gastric Cancer

Intervention / Treatment
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* Drug: NACT
* Procedure: SDM
* Procedure: Surgery
* Drug: ACT
* Other: Questionnaire


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Histologically proven adenocarcinoma of the stomach Clinical cT2N+M0,or cT3-4a/N+M0 disease, confirmed by upper gastrointestinal endoscopy and abdominal computed tomography (CT) and MRI and laparoscopy. Receive neoadjuvant chemotherapy in clinical Exclusion Criteria: Contraindication for chemotherapy Contraindication for surgery Clinically apparent distant metastasis
Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Intervention Model: Sequential Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: experiment group<br>Neoadjuvant chemotherapy(NACT) are performed for locally advanced gastric cancer. The clinical response is evaluated by MRI and enhanced CT. The cycle of neoadjuvant chemotherapy is decided by the doctor and the patents together with shared decision making(SDM). Radical gastrectomy with D2 lymph node dissection are performed after neoadjuvant chemotherapy. Adjuvant chemotherapy(ACT) are preformed after surgery. Questionnaires are preformed to evaluate the involvement emotion and reason for the decision of stopping neoadjuvant chemotherapy. | Drug: NACT<br>* SOX: Oxaliplatin 130mg/m2,iv.,d1; S-1 60mg,po.,Bid,d1-14; Repeat every 21 days for n courses.(0<n<8)<br>Procedure: SDM<br>* Making the decision about the cycle of neoadjuvant chemotherapy with shared decision making<br>Procedure: Surgery<br>* Radical surgery with D2 lymph node dissection<br>Drug: ACT<br>* SOX: Oxaliplatin 130mg/m2,iv.,d1; S-1 60mg,po.,Bid,d1-14; Repeat every 21 days for 8-n courses.(0<n<8)<br>Other: Questionnaire<br>* 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<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| The 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 | 18months | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| The clinical response rate | The clinical response is evaluated by CT/MRI according to the Response Evaluation Criteria In Solid Tumors (RECIST)1.1 | 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) | 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 | 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. | 18 months | 
| The pathological complete response | The pathological complete response is defined as ypT0N0M0 | 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 | 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. | 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 | 48months | 
| The cTNM,ycTNM,ypTNM stage | The cTNM stage, ycTNM stage and ypTNM stage is defined according to the 8th TNM stage. | 60months | 
| The decisional conflicts | The decisional conflicts is evaluated by Decisional Conflict Scale | 12months | 
| The decisional regrets | The decisional regrets is evaluated by Decision Regret Scale | 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 | 12months | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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MRI, shared decision making, neoadjuvant chemotherapy, cycle, clinical response