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Neoadjuvant Chemotherapy for Patients With Advanced Gastric Cancer in ERAS Programs for Radical Gastrectomy

Primary Purpose

Gastric Cancer

Status

Completed

Phase

Not Applicable

Locations

China

Study Type

Interventional

Intervention

NAC group

Surgery alone group

About this trial

This is an interventional treatment trial for Gastric Cancer focused on measuring gastric cancer, neoadjuvant chemotherapy, enhanced recovery after surgery, gastrectomy

Eligibility Criteria

18 Years - 75 Years (Adult, Older Adult)All SexesDoes not accept healthy volunteers

Inclusion Criteria:

Patients with locally advanced gastric cancer.
Age older than 18 and younger than 75 years.
American Society of Anesthesiologists (ASA) class: I-III.
Participants can describe the symptom objectively and cooperate actively.
Written informed consent

Exclusion Criteria:

Patients allergic to oxaliplatin, tegafur gimerac etc.
Patients with ischemic heart disease, cerebrovascular disease and peripheral vascular disease, or cardiac function > II (NYHA)
Patients with complications (bleeding, perforation and obstruction) caused by gastric cancer.
Patients with severe liver and renal dysfunction (Child - Pugh ≥ 10; Cr < 25 ml/min).
Patients who require simultaneous surgery for other diseases.
Patients who received upper abdominal surgery previously.
Pregnant or breast-feeding women.

Sites / Locations

Jinling Hospital, Medical School of Nanjing University

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Active Comparator

Arm Label

NAC group

Surgery alone group

Arm Description

Patients will receive neoadjuvant chemotherapy (NAC) before the gastrectomy and ERAS.

Patients will not receive NAC before the gastrectomy and ERAS.

Outcomes

Primary Outcome Measures

Postoperative length of stay

Secondary Outcome Measures

Postoperative complications

The time to first flatus

Bowel recovery

Time to semi-liquid diet

Bowel recovery

Total protein

Nutritional status

Albumin

Nutritional status

Prealbumin

Nutritional status

Full Information

NCT ID

NCT03238404

First Posted

July 27, 2017

Last Updated

August 2, 2017

Sponsor

JIANG Zhi-Wei

1. Study Identification

Unique Protocol Identification Number

NCT03238404

Brief Title

Neoadjuvant Chemotherapy for Patients With Advanced Gastric Cancer in ERAS Programs for Radical Gastrectomy

Official Title

The Application of Neoadjuvant Chemotherapy for Patients With Advanced Gastric Cancer in Enhanced Recovery After Surgery Programs for Radical Gastrectomy

Study Type

Interventional

2. Study Status

Record Verification Date

August 2017

Overall Recruitment Status

Completed

Study Start Date

August 1, 2015 (Actual)

Primary Completion Date

August 10, 2016 (Actual)

Study Completion Date

December 20, 2016 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title

Sponsor-Investigator

Name of the Sponsor

JIANG Zhi-Wei

4. Oversight

Studies a U.S. FDA-regulated Drug Product

Studies a U.S. FDA-regulated Device Product

Data Monitoring Committee

Yes

5. Study Description

Brief Summary

Patients with advanced gastric cancer received neoadjuvant chemotherapy undergo enhanced recovery after surgery (ERAS) programs.

Detailed Description

In recent years, enhanced recovery after surgery (ERAS) programs were applied in gastrectomy in areas with a high prevalence of gastric cancer, such as China and Japan, confirming that ERAS programs accelerate the postoperative rehabilitation of gastric cancer patients without increasing the occurrence rate of postoperative complications. However, in most studies on ERAS for gastric cancer, patients who received neoadjuvant chemotherapy were excluded. Investigators designed this study aimed to evaluate whether patients who receive neoadjuvant chemotherapy can enrolled into enhanced recovery after surgery programs for locally advanced gastric cancer.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study

Gastric Cancer

Keywords

gastric cancer, neoadjuvant chemotherapy, enhanced recovery after surgery, gastrectomy

7. Study Design

Primary Purpose

Treatment

Study Phase

Not Applicable

Interventional Study Model

Parallel Assignment

Model Description

This study is a single-center, parallel, open-label randomized controlled trial.

Masking

None (Open Label)

Allocation

Randomized

Enrollment

88 (Actual)

8. Arms, Groups, and Interventions

Arm Title

NAC group

Arm Type

Experimental

Arm Description

Patients will receive neoadjuvant chemotherapy (NAC) before the gastrectomy and ERAS.

Arm Title

Surgery alone group

Arm Type

Active Comparator

Arm Description

Patients will not receive NAC before the gastrectomy and ERAS.

Intervention Type

Procedure

Intervention Name(s)

NAC group

Intervention Description

NAC is the name of a procedure. NAC doesn't mean different interventions are used. Patients in this group need receive this NAC procedure instead of one drug before the gastrectomy and ERAS. The program consists of an intravenous injection of 130 mg/m2 oxaliplatin on day 1, followed by oral administration of 50 mg tegafur gimerac (the name of an anticarcinogen) twice daily on days 1-14, every 3 weeks.

Intervention Type

Procedure

Intervention Name(s)

Surgery alone group

Intervention Description

Patients will not receive neoadjuvant chemotherapy and they will undergo the gastrectomy and ERAS alone.

Primary Outcome Measure Information:

Title

Postoperative length of stay

Description

Postoperative length of stay

Time Frame

1 month

Secondary Outcome Measure Information:

Title

Postoperative complications

Description

Postoperative complications

Time Frame

2 months

Title

The time to first flatus

Description

Bowel recovery

Time Frame

1 week

Title

Time to semi-liquid diet

Description

Bowel recovery

Time Frame

2 weeks

Title

Total protein

Description

Nutritional status

Time Frame

1 week

Title

Albumin

Description

Nutritional status

Time Frame

1 week

Title

Prealbumin

Description

Nutritional status

Time Frame

1 week

10. Eligibility

Sex

All

Minimum Age & Unit of Time

18 Years

Maximum Age & Unit of Time

75 Years

Accepts Healthy Volunteers

Eligibility Criteria

Inclusion Criteria: Patients with locally advanced gastric cancer. Age older than 18 and younger than 75 years. American Society of Anesthesiologists (ASA) class: I-III. Participants can describe the symptom objectively and cooperate actively. Written informed consent Exclusion Criteria: Patients allergic to oxaliplatin, tegafur gimerac etc. Patients with ischemic heart disease, cerebrovascular disease and peripheral vascular disease, or cardiac function > II (NYHA) Patients with complications (bleeding, perforation and obstruction) caused by gastric cancer. Patients with severe liver and renal dysfunction (Child - Pugh ≥ 10; Cr < 25 ml/min). Patients who require simultaneous surgery for other diseases. Patients who received upper abdominal surgery previously. Pregnant or breast-feeding women.

Overall Study Officials:

First Name & Middle Initial & Last Name & Degree

Zhi-Wei JIANG, Ph.D.

Organizational Affiliation

Jinling Hospital, Medical School of Nanjing University

Official's Role

Principal Investigator

First Name & Middle Initial & Last Name & Degree

Jian ZHAO, Ph.D.

Organizational Affiliation

Jinling Hospital, Medical School of Nanjing University

Official's Role

Study Director

Facility Information:

Facility Name

Jinling Hospital, Medical School of Nanjing University

City

Nanjing

State/Province

Jiangsu

ZIP/Postal Code

210002

Country

China

12. IPD Sharing Statement

Plan to Share IPD

Undecided

IPD Sharing Plan Description

The results and IPD will be considered to share in published articles.

Learn more about this trial

Neoadjuvant Chemotherapy for Patients With Advanced Gastric Cancer in ERAS Programs for Radical Gastrectomy

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