Early Recovery After Surgery Protocol in Improving Quality of Life in Participants With Stage 0-IIIC Gastric Cancer Undergoing Surgery

NCT03997162 | Active Not Recruiting DMC

• 2 other identifiers: 17482NCI-2018-01639
• Study Type: observational
• Target: 52
• Locations: 1 country
• Sites: 1

Brief Summary

This phase II trial studies how well an early recovery after surgery protocol works in enhancing quality of life in participants with stage 0-IIIC gastric cancer undergoing surgery. The early recovery after surgery protocol may decrease pain and nausea, promote bowl function, decrease the number of days hospitalized, and improve a participant's ability to function normally after surgery.

Conditions

Clinical Stage II Gastric Cancer AJCC v8; Clinical Stage IIA Gastric Cancer AJCC v8; Clinical Stage IIB Gastric Cancer AJCC v8; Clinical Stage III Gastric Cancer AJCC v8; Gastric Adenocarcinoma; Pathologic Stage 0 Gastric Cancer AJCC v8; Pathologic Stage I Gastric Cancer AJCC v8; Pathologic Stage IA Gastric Cancer AJCC v8; Pathologic Stage III Gastric Cancer AJCC v8; Pathologic Stage IIIA Gastric Cancer AJCC v8; Pathologic Stage IIIB Gastric Cancer AJCC v8; Pathologic Stage IIIC Gastric Cancer AJCC v8; Clinical Stage I Gastric Cancer AJCC v8; Pathologic Stage II Gastric Cancer AJCC v8; Pathologic Stage IIA Gastric Cancer AJCC v8; Pathologic Stage IIB Gastric Cancer AJCC v8; Clinical Stage 0 Gastric Cancer AJCC v8; Pathologic Stage IB Gastric Cancer AJCC v8

Outcome Measures

Primary Outcomes (2)

• Length of stay

  Will determine the length of hospital stay after surgery

  from date of surgery to discharge from hospital, assessed up to 30 days

• Rate and type of post-operative complications

  Up to 1 year

Secondary Outcomes (2)

• Overall quality of life assessment

  One time within 30 days of surgery, One time within 30 days after surgery, One time at 3 months after surgery, One time 6 months after surgery, One time 12 months after surgery

• QoL after stomach cancer surgery

  One time within 30 days of surgery, One time within 30 days after surgery, One time at 3 months after surgery, One time 6 months after surgery, One time 12 months after surgery

Other Outcomes (4)

• Ambulation

  From time of surgery to first postoperative clinic visit, assessed up to 30 days

• Immune biomarkers

  one time 30 days within surgery, One time 1 day after surgery, One time 3 days after surgery, One time 30 days after surgery, One time 90 days after surgery, one time 6 months after surgery, One time 12 months after surgery

• Disease free survival of enrolled patients

  Up to 14 months after surgery

Study Arms (1)

Observational (ERAS protocol)

Participants complete standard of care early recovery after surgery protocol beginning the day before surgery to day 6 after surgery.

Other: Best Practice; Other: Quality-of-Life Assessment; Other: Questionnaire Administration

Interventions

Best Practice OTHER

Complete standard of care enhanced recovery after surgery protocol

Also known as: standard of care, standard therapy

Observational (ERAS protocol)

Quality-of-Life Assessment OTHER

Ancillary studies

Also known as: Quality of Life Assessment

Observational (ERAS protocol)

Questionnaire Administration OTHER

Ancillary studies

Observational (ERAS protocol)

Eligibility Criteria

• Age: 18 Years - 99 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

Study Population

Patients with a biopsy proven diagnosis of gastric adenocarcinoma who are undergoing curative gastric surgery or prophylactic total gastrectomy for genetic risk

You may qualify if:

• Patients to be included are those with a biopsy proven diagnosis of gastric adenocarcinoma who are undergoing curative gastric surgery or prophylactic total gastrectomy for genetic risk.
• Patients with clinical stage 0-IIIC will be included.
• Any performance status and any life expectancy.
• The effects of gastric surgery on the developing fetus are unknown. For this reason, women of childbearing potential and men must agree to use adequate contraception (hormonal or barrier method of birth control or abstinence) prior to study entry and for six months following duration of study participation. Should a woman become pregnant or suspect that she is pregnant while participating on the trial, she should inform her treating physician immediately.
• All subjects must have the ability to understand and the willingness to sign a written informed consent.
• Prior therapy will not be used as a limitation in this study.

You may not qualify if:

• Patients will be excluded if they are not candidates for surgery
• Patients will be excluded from the study if they have had prior gastric surgery, with the exception of a gastrostomy tube.
• Subjects, who in the opinion of the investigator, may not be able to comply with the safety monitoring requirements of the study.

Sponsors & Collaborators

• National Cancer Institute (NCI): collaborator
• City of Hope Medical Center: lead

Study Sites (1)

City of Hope Medical Center

Duarte, California, 91010, United States

Location

MeSH Terms

Interventions

Practice Guidelines as Topic; Standard of Care

Intervention Hierarchy (Ancestors)

Guidelines as Topic; Quality Assurance, Health Care; Quality of Health Care; Health Services Administration; Health Care Quality, Access, and Evaluation; Quality Indicators, Health Care

Study Officials

• Yanghee Woo

  City of Hope Medical Center

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: observational
• Observational Model: CASE ONLY
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: August 6, 2018
• First Posted: June 25, 2019
• Study Start: October 11, 2018
• Primary Completion: January 18, 2023
• Study Completion (Estimated): January 7, 2027
• Last Updated: February 24, 2026

Record last verified: 2026-02

Locations

US (1)