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

Active, not recruiting

• Conditions: Clinical Stage II Gastric Cancer AJCC v8; Pathologic Stage I Gastric Cancer AJCC v8; Clinical Stage III Gastric Cancer AJCC v8; Gastric Adenocarcinoma; Pathologic Stage IA Gastric Cancer AJCC v8; Pathologic Stage III Gastric Cancer AJCC v8; Pathologic Stage IIIB Gastric Cancer AJCC v8; Clinical Stage IIB Gastric Cancer AJCC v8; Pathologic Stage II Gastric Cancer AJCC v8; Clinical Stage 0 Gastric Cancer AJCC v8
• Interventions: Other: Best Practice; Other: Quality-of-Life Assessment; Other: Questionnaire Administration

• Registration Number: NCT03997162
• Lead Sponsor: City of Hope Medical Center

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.

Detailed Description

PRIMARY OBJECTIVES:

I. Determine how the enhanced recovery after surgery (ERAS) protocol affects patient?s length of hospital stay after radical gastrectomy.

II. Determine the association between ambulation (number of steps taken) while hospitalized and complications.

III. Determine the association between pre-operatively and postoperatively drawn biochemical markers and complications, disease free survival, and overall survival.

OUTLINE:

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

After completion of study, participants are followed up at days 14, 30, 80-110, and 170-200, and at 11-14 months.

Study Timeline

• Study First Submitted: 2018-08-06
• Study Start: 2018-10-11
• Study First Submitted QC: 2019-06-24
• Study First Posted: 2019-06-25
• Primary Completion: 2023-01-18
• Status Verified: 2025-03
• Last Update Submitted: 2025-03-18
• Last Update Posted: 2025-03-20
• Study Completion: 2026-02-04

Recruitment & Eligibility

• Status: ACTIVE_NOT_RECRUITING
• Sex: All
• Target Recruitment: 52

Inclusion Criteria

• 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.

Exclusion Criteria

• 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.

Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Arm && Interventions

Group	Intervention	Description
Observational (ERAS protocol)	Best Practice	Participants complete standard of care early recovery after surgery protocol beginning the day before surgery to day 6 after surgery.
Observational (ERAS protocol)	Quality-of-Life Assessment	Participants complete standard of care early recovery after surgery protocol beginning the day before surgery to day 6 after surgery.
Observational (ERAS protocol)	Questionnaire Administration	Participants complete standard of care early recovery after surgery protocol beginning the day before surgery to day 6 after surgery.

Primary Outcome Measures

Name	Time	Method
Rate and type of post-operative complications	Up to 1 year
Length of stay	from date of surgery to discharge from hospital, assessed up to 30 days	Will determine the length of hospital stay after surgery

Secondary Outcome Measures

Name	Time	Method
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	EORTC QLQ-C30 questionnaires to measure Quality of life
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	STO22 questionnaires to measure stomach cancer surgery related QoL

Trial Locations

Locations (1)

City of Hope Medical Center; 🇺🇸 Duarte, California, United States