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

Not Applicable

• Conditions: Gastric Cancer
• Interventions: Drug: NACT; Procedure: SDM; Procedure: Surgery; Drug: ACT; Other: Questionnaire

• Registration Number: NCT03413514
• Lead Sponsor: Peking University

Brief 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.

Study Timeline

• Status Verified: 2018-01
• Study Start: 2018-01-03
• Study First Submitted: 2018-01-14
• Study First Submitted QC: 2018-01-22
• Last Update Submitted: 2018-01-22
• Study First Posted: 2018-01-29
• Last Update Posted: 2018-01-29
• Primary Completion: 2019-01-03
• Study Completion: 2023-01-03

Recruitment & Eligibility

• Status: UNKNOWN
• Sex: All
• Target Recruitment: 100

Inclusion Criteria

1. Histologically proven adenocarcinoma of the stomach
2. Clinical cT2N+M0,or cT3-4a/N+M0 disease, confirmed by upper gastrointestinal endoscopy and abdominal computed tomography (CT) and MRI and laparoscopy.
3. Receive neoadjuvant chemotherapy in clinical

Exclusion Criteria

1. Contraindication for chemotherapy
2. Contraindication for surgery
3. Clinically apparent distant metastasis

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: SEQUENTIAL

Arm && Interventions

Group	Intervention	Description
experiment group	ACT	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.
experiment group	Questionnaire	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.
experiment group	NACT	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.
experiment group	Surgery	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.
experiment group	SDM	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.

Primary Outcome Measures

Name	Time	Method
The cycle of neoadjuvant chemotherapy	18months	The cycle of neoadjuvant chemotherapy means the maximal cycle of effective neoadjuvant chemotherapy. The effective means no disease progress by image diagnosis

Secondary Outcome Measures

Name	Time	Method
The completion rate of perioperative chemotherapy	18 months	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)
Surgical morbidity	18 months	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.
The cTNM,ycTNM,ypTNM stage	60months	The cTNM stage, ycTNM stage and ypTNM stage is defined according to the 8th TNM stage.
The clinical response rate	18 months	The clinical response is evaluated by CT/MRI according to the Response Evaluation Criteria In Solid Tumors (RECIST)1.1
The progressive disease rate	18 months	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
The pathological response	18 months	The pathological response during neoadjuvant chemotherapy with shared decision making is evaluated according to the tumor regression grade of NCCN guideline.
The pathological complete response	18months	The pathological complete response is defined as ypT0N0M0
The adverse event of chemotherapy	18 months	The adverse event of chemotherapy is evaluated and recorded according to the Common Terminology Criteria for Adverse Events (CTCAE) v.3
The decisional conflicts	12months	The decisional conflicts is evaluated by Decisional Conflict Scale
The decisional regrets	12months	The decisional regrets is evaluated by Decision Regret Scale
The involvement of patients during the shared decision making	12months	The involvement of patients during the shared decision making is evaluated by MAPPIN'SDM questionnaire
The 3-year progression-free survival	48months	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

Trial Locations

Locations (1)

Peking University Cancer Hospital; 🇨🇳 Beijing, Beijing, China