Clinical Stage 0 Gastric Cancer AJCC v8NCT03997162
Early Recovery After Surgery Protocol in Improving Quality of Life in Participants With Stage 0-IIIC Gastric Cancer Undergoing Surgery
An observational study of Clinical Stage 0 Gastric Cancer AJCC v8 and Clinical Stage I Gastric Cancer AJCC v8, run by City of Hope Medical Center at 1 site in United States.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 to 99 years
- Conditions the study is for
- Clinical Stage 0 Gastric Cancer AJCC v8, Clinical Stage I Gastric Cancer AJCC v8, Clinical Stage II Gastric Cancer AJCC v8
- What is being tested?
- Best Practice, Quality-of-Life Assessment and Questionnaire Administration
- How many people
- 52 participants
- Where
- 1 siteUnited States
- Study dates
- 8 Jan 2019to 7 Jan 2027
- Phase
- Observational
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 99 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Study population: Patients with a biopsy proven diagnosis of gastric adenocarcinoma who are undergoing curative gastric surgery or prophylactic total gastrectomy for genetic risk
Who may be able to join
- 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.
Who cannot join
- 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.
Trial locations and contacts
1 site in 1 country.
United States1 site
City of Hope Medical Center
Duarte, California, 91010
About this study
Official title: Gastric Cancer Enhanced Recovery After Surgery Pathway
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.
Read the detailed description
PRIMARY OBJECTIVES:
- 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.
- 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
- Being tested
- Best Practice, Quality-of-Life Assessment, Questionnaire Administration
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Best PracticeOther
Also called standard of care, standard therapy
Complete standard of care enhanced recovery after surgery protocol
Quality-of-Life AssessmentOther
Also called Quality of Life Assessment
Ancillary studies
Questionnaire AdministrationOther
Ancillary studies
| Study group | Role | What they receive |
|---|---|---|
| Observational (ERAS protocol) | Participants complete standard of care early recovery after surgery protocol beginning the day before surgery to day 6 after surgery. Receives: Other: Best Practice; Other: Quality-of-Life Assessment; Other: Questionnaire Administration |
What is being measured
The primary outcome is the main question the study is designed to answer.
Length of stay
Will determine the length of hospital stay after surgery
Measured: from date of surgery to discharge from hospital, assessed up to 30 days
Rate and type of post-operative complications
Measured: Up to 1 year
Secondary outcomes (2)
Overall quality of life assessment
EORTC QLQ-C30 questionnaires to measure Quality of life
Measured: 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
STO22 questionnaires to measure stomach cancer surgery related QoL
Measured: 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
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted25 Jun 2019
- Study start8 Jan 2019
- Primary completion18 Jan 2023
- Study completion7 Jan 2027 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Clinical Stage 0 Gastric Cancer AJCC v8Studies of the same condition, open and under way.
- More trials run by City of Hope Medical CenterThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Case only
- Time perspective
- Prospective
- Enrolment
- 52 participants (actual)
Sponsor and investigators
- Lead sponsor
- City of Hope Medical Center
- Sponsor type
- University, hospital or other
- Collaborators
- National Cancer Institute (NCI)
- Responsible party
- Sponsor
- Investigators
- Yanghee Woo, Principal investigator, City of Hope Medical Center
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03997162
- Sponsor's protocol ID
- 17482
- Other IDs
- NCI-2018-01639, 17482
- Status last verified
- Oct 2026
- First submitted
- 6 Aug 2018
- Last updated
- 22 Oct 2026
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 22 Oct 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Gastric Cancer Enhanced Recovery After Surgery Pathway
- ClinicalTrials.gov ID
- NCT03997162
- Acronym / sponsor ID
- 17482
- 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
- Study type
- Observational
- Recruitment status
- Active, not recruiting
- Enrolment
- 52 participants (actual)
- Lead sponsor
- City of Hope Medical CenterUniversity, hospital or other
- Collaborators
- National Cancer Institute (NCI)
- Study start
- 8 Jan 2019 (actual)
- Primary completion
- 18 Jan 2023 (actual)
- Study completion
- 7 Jan 2027 (estimated)
- First posted
- 25 Jun 2019 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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:
- 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 design
- Observational model
- Case only
- Time perspective
- Prospective
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Observational (ERAS protocol) | – | Other: Best Practice, Other: Quality-of-Life Assessment, Other: Questionnaire AdministrationParticipants complete standard of care early recovery after surgery protocol beginning the day before surgery to day 6 after surgery. |
Who may qualify
- Ages
- 18 to 99 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- Patients with a biopsy proven diagnosis of gastric adenocarcinoma who are undergoing curative gastric surgery or prophylactic total gastrectomy for genetic risk
Key inclusion criteria (6 listed)
- 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.
Key exclusion criteria (3 listed)
- 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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Best PracticeAlso: standard of care, standard therapyComplete standard of care enhanced recovery after surgery protocol | Other | Observational (ERAS protocol) |
| Quality-of-Life AssessmentAlso: Quality of Life AssessmentAncillary studies | Other | Observational (ERAS protocol) |
| Questionnaire AdministrationAncillary studies | Other | Observational (ERAS protocol) |
Primary outcome
Length of stay
Time frame: from date of surgery to discharge from hospital, assessed up to 30 days
Will determine the length of hospital stay after surgery
Rate and type of post-operative complications
Time frame: Up to 1 year
2 secondary outcomes
Overall quality of life assessment
Time frame: 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
Time frame: 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
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 22 Oct 2026.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Yanghee Woo principal investigator
City of Hope Medical Center
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Clinical Stage 0 Gastric Cancer AJCC v8 and Clinical Stage I Gastric Cancer AJCC v8, run by City of Hope Medical Center at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 6 inclusion and 3 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: under way, not looking for participants, as of the sponsor's last update on 22 Oct 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Length of stay (time frame: from date of surgery to discharge from hospital, assessed up to 30 days). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 22 Oct 2026.