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

Sponsor

Peking University (Other)

Overall Status

Recruiting

CT.gov ID

NCT03413514

Collaborator

(none)

100

Enrollment

Location

Arm

Anticipated Duration (Months)

1.7

Patients Per Site Per Month

Study Details

Study Description

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.

Condition or Disease	Intervention/Treatment	Phase
Gastric Cancer	Drug: NACT Procedure: SDM Procedure: Surgery Drug: ACT Other: Questionnaire	N/A

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 Design

Study Type:

Interventional

Anticipated Enrollment :

100 participants

Intervention Model:

Sequential Assignment

Masking:

None (Open Label)

Primary Purpose:

Treatment

Official Title:

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

Actual Study Start Date :

Jan 3, 2018

Anticipated Primary Completion Date :

Jan 3, 2019

Anticipated Study Completion Date :

Jan 3, 2023

Arms and Interventions

Arm	Intervention/Treatment
Experimental: experiment group 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 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

Arm

Intervention/Treatment

Experimental: experiment group

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

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

Outcome Measures

Primary Outcome Measures

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

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 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)
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
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 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
The cTNM,ycTNM,ypTNM stage [60months]
The cTNM stage, ycTNM stage and ypTNM stage is defined according to the 8th TNM stage.
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

Eligibility Criteria

Criteria

Ages Eligible for Study:

N/A and Older

Sexes Eligible for Study:

All

Accepts Healthy Volunteers:

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

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1	Peking University Cancer Hospital	Beijing	Beijing	China	100142

Sponsors and Collaborators

Peking University

Investigators

Principal Investigator: Ziyu Li, MD, Peking University Cancer Hospital & Institute
Principal Investigator: Jiafu Ji, MD,PHD, Peking University Cancer Hospital & Institute