Clinical trial NCT03997162: Early Recovery After Surgery Protocol in Improving Quality of Life in Participants With Stage 0-IIIC Gastric Cancer Undergoing Surgery
Official title: Gastric Cancer Enhanced Recovery After Surgery Pathway
Study type: OBSERVATIONAL
Overall status: ACTIVE_NOT_RECRUITING
Conditions: Clinical Stage 0 Gastric Cancer AJCC v8
Clinical Stage I Gastric Cancer AJCC v8
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 IB 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
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
Lead sponsor: City of Hope Medical Center
Sponsor class: OTHER
Collaborators: name: National Cancer Institute (NCI)
First posted: 2019-06-25
Enrollment: 52
Sex: ALL
Minimum age (years): 18
Maximum age (years): 99
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: CASE_ONLY
Time perspective: PROSPECTIVE
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

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.

Eligibility criteria: 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.

Primary outcomes:
measure: Length of stay
timeFrame: from date of surgery to discharge from hospital, assessed up to 30 days
measure: Rate and type of post-operative complications
timeFrame: Up to 1 year
Secondary outcomes:
measure: Overall quality of life assessment
timeFrame: 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
measure: QoL after stomach cancer surgery
timeFrame: 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:
measure: Ambulation
timeFrame: From time of surgery to first postoperative clinic visit, assessed up to 30 days
measure: Immune biomarkers
timeFrame: 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
measure: Disease free survival of enrolled patients
timeFrame: Up to 14 months after surgery
measure: Overall survival of enrolled patients
timeFrame: Up to 14 months after surgery
Locations:
city: Duarte
country: United States
facility: City of Hope Medical Center
state: California
Study officials:
affiliation: City of Hope Medical Center
name: Yanghee Woo
role: PRINCIPAL_INVESTIGATOR
References: