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

Primary Purpose

Gastric Cancer

Status
Unknown status
Phase
Not Applicable
Locations
China
Study Type
Interventional
Intervention
NACT
SDM
Surgery
ACT
Questionnaire
Sponsored by
Peking University
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Gastric Cancer focused on measuring shared decision making, neoadjuvant chemotherapy, cycle, MRI, clinical response

Eligibility Criteria

undefined - undefined (Child, Adult, Older Adult)All SexesDoes not accept healthy volunteers

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

Sites / Locations

  • Peking University Cancer HospitalRecruiting

Arms of the Study

Arm 1

Arm Type

Experimental

Arm Label

experiment group

Arm Description

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.

Outcomes

Primary Outcome Measures

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

Secondary Outcome Measures

The clinical response rate
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
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
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
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
The pathological complete response is defined as ypT0N0M0
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
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.
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
The cTNM,ycTNM,ypTNM stage
The cTNM stage, ycTNM stage and ypTNM stage is defined according to the 8th TNM stage.
The decisional conflicts
The decisional conflicts is evaluated by Decisional Conflict Scale
The decisional regrets
The decisional regrets is evaluated by Decision Regret Scale
The involvement of patients during the shared decision making
The involvement of patients during the shared decision making is evaluated by MAPPIN'SDM questionnaire

Full Information

First Posted
January 14, 2018
Last Updated
January 22, 2018
Sponsor
Peking University
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1. Study Identification

Unique Protocol Identification Number
NCT03413514
Brief Title
Real World Evidence for the Cycle of Neoadjuvant Chemotherapy in Gastric Cancer With Shared Decision Making
Acronym
RECOMMEND
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
Study Type
Interventional

2. Study Status

Record Verification Date
January 2018
Overall Recruitment Status
Unknown status
Study Start Date
January 3, 2018 (Actual)
Primary Completion Date
January 3, 2019 (Anticipated)
Study Completion Date
January 3, 2023 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Peking University

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
Yes

5. 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.
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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Gastric Cancer
Keywords
shared decision making, neoadjuvant chemotherapy, cycle, MRI, clinical response

7. Study Design

Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Sequential Assignment
Masking
None (Open Label)
Enrollment
100 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
experiment group
Arm Type
Experimental
Arm Description
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.
Intervention Type
Drug
Intervention Name(s)
NACT
Intervention Description
SOX: Oxaliplatin 130mg/m2,iv.,d1; S-1 60mg,po.,Bid,d1-14; Repeat every 21 days for n courses.(0<n<8)
Intervention Type
Procedure
Intervention Name(s)
SDM
Intervention Description
Making the decision about the cycle of neoadjuvant chemotherapy with shared decision making
Intervention Type
Procedure
Intervention Name(s)
Surgery
Intervention Description
Radical surgery with D2 lymph node dissection
Intervention Type
Drug
Intervention Name(s)
ACT
Intervention Description
SOX: Oxaliplatin 130mg/m2,iv.,d1; S-1 60mg,po.,Bid,d1-14; Repeat every 21 days for 8-n courses.(0<n<8)
Intervention Type
Other
Intervention Name(s)
Questionnaire
Intervention Description
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
Primary Outcome Measure Information:
Title
The cycle of neoadjuvant chemotherapy
Description
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
Secondary Outcome Measure Information:
Title
The clinical response rate
Description
The clinical response is evaluated by CT/MRI according to the Response Evaluation Criteria In Solid Tumors (RECIST)1.1
Time Frame
18 months
Title
The completion rate of perioperative chemotherapy
Description
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
Title
The progressive disease rate
Description
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
Title
The pathological response
Description
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
Title
The pathological complete response
Description
The pathological complete response is defined as ypT0N0M0
Time Frame
18months
Title
The adverse event of chemotherapy
Description
The adverse event of chemotherapy is evaluated and recorded according to the Common Terminology Criteria for Adverse Events (CTCAE) v.3
Time Frame
18 months
Title
Surgical morbidity
Description
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
Title
The 3-year progression-free survival
Description
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
Title
The cTNM,ycTNM,ypTNM stage
Description
The cTNM stage, ycTNM stage and ypTNM stage is defined according to the 8th TNM stage.
Time Frame
60months
Title
The decisional conflicts
Description
The decisional conflicts is evaluated by Decisional Conflict Scale
Time Frame
12months
Title
The decisional regrets
Description
The decisional regrets is evaluated by Decision Regret Scale
Time Frame
12months
Title
The involvement of patients during the shared decision making
Description
The involvement of patients during the shared decision making is evaluated by MAPPIN'SDM questionnaire
Time Frame
12months

10. Eligibility

Sex
All
Accepts Healthy Volunteers
No
Eligibility Criteria
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
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Ziyu Li, MD
Phone
86-010-8819-6605
Email
ligregory@outlook.com
First Name & Middle Initial & Last Name or Official Title & Degree
Yinkui Wang, MD
Phone
86-010-88196598
Email
wykchangfeng@163.com
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Ziyu Li, MD
Organizational Affiliation
Peking University Cancer Hospital & Institute
Official's Role
Principal Investigator
First Name & Middle Initial & Last Name & Degree
Jiafu Ji, MD,PHD
Organizational Affiliation
Peking University Cancer Hospital & Institute
Official's Role
Principal Investigator
Facility Information:
Facility Name
Peking University Cancer Hospital
City
Beijing
State/Province
Beijing
ZIP/Postal Code
100142
Country
China
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Ziyu Li, M.D.
Phone
86-010-8819-6605
Email
ligregory@outlook.com
First Name & Middle Initial & Last Name & Degree
Yinkui Wang, M.D.
Phone
86-010-8819-6598
Email
wykchangfeng@163.com
First Name & Middle Initial & Last Name & Degree
Ziyu Li, M.D.
First Name & Middle Initial & Last Name & Degree
Fei Shan, M.D.
First Name & Middle Initial & Last Name & Degree
Yinkui Wang, M.D.
First Name & Middle Initial & Last Name & Degree
Shuangxi Li, M.D.
First Name & Middle Initial & Last Name & Degree
Yongning Jia, M.D.
First Name & Middle Initial & Last Name & Degree
Hui Ren, M.M.
First Name & Middle Initial & Last Name & Degree
Yingai Li, M.B.
First Name & Middle Initial & Last Name & Degree
Xiangji Ying, M.S., M.P.H.
First Name & Middle Initial & Last Name & Degree
Fei Pang, M.M.
First Name & Middle Initial & Last Name & Degree
Jiafu Ji, M.D., P.H.D

12. IPD Sharing Statement

Citations:
PubMed Identifier
25651787
Citation
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Results Reference
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PubMed Identifier
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Citation
Chen W, Zheng R, Baade PD, Zhang S, Zeng H, Bray F, Jemal A, Yu XQ, He J. Cancer statistics in China, 2015. CA Cancer J Clin. 2016 Mar-Apr;66(2):115-32. doi: 10.3322/caac.21338. Epub 2016 Jan 25.
Results Reference
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PubMed Identifier
27342689
Citation
Japanese Gastric Cancer Association. Japanese gastric cancer treatment guidelines 2014 (ver. 4). Gastric Cancer. 2017 Jan;20(1):1-19. doi: 10.1007/s10120-016-0622-4. Epub 2016 Jun 24. No abstract available.
Results Reference
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PubMed Identifier
23838904
Citation
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Results Reference
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PubMed Identifier
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Citation
Aoyama T, Nishikawa K, Fujitani K, Tanabe K, Ito S, Matsui T, Miki A, Nemoto H, Sakamaki K, Fukunaga T, Kimura Y, Hirabayashi N, Yoshikawa T. Early results of a randomized two-by-two factorial phase II trial comparing neoadjuvant chemotherapy with two and four courses of cisplatin/S-1 and docetaxel/cisplatin/S-1 as neoadjuvant chemotherapy for locally advanced gastric cancer. Ann Oncol. 2017 Aug 1;28(8):1876-1881. doi: 10.1093/annonc/mdx236.
Results Reference
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PubMed Identifier
25530271
Citation
Schulz C, Kullmann F, Kunzmann V, Fuchs M, Geissler M, Vehling-Kaiser U, Stauder H, Wein A, Al-Batran SE, Kubin T, Schafer C, Stintzing S, Giessen C, Modest DP, Ridwelski K, Heinemann V. NeoFLOT: Multicenter phase II study of perioperative chemotherapy in resectable adenocarcinoma of the gastroesophageal junction or gastric adenocarcinoma-Very good response predominantly in patients with intestinal type tumors. Int J Cancer. 2015 Aug 1;137(3):678-85. doi: 10.1002/ijc.29403. Epub 2015 Feb 25.
Results Reference
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PubMed Identifier
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Citation
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Results Reference
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PubMed Identifier
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Citation
Fried TR. Shared Decision Making--Finding the Sweet Spot. N Engl J Med. 2016 Jan 14;374(2):104-6. doi: 10.1056/NEJMp1510020. No abstract available.
Results Reference
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Real World Evidence for the Cycle of Neoadjuvant Chemotherapy in Gastric Cancer With Shared Decision Making

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