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出境医 / 临床实验 / Early Recovery After Surgery Protocol in Improving Quality of Life in Participants With Stage 0-IIIC Gastric Cancer Undergoing Surgery
Early Recovery After Surgery Protocol in Improving Quality of Life in Participants With Stage 0-IIIC Gastric Cancer Undergoing Surgery
Study Description
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.
| Condition or disease | Intervention/treatment |
|---|---|
| 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 | Other: Best Practice Other: Quality-of-Life Assessment Other: Questionnaire Administration |
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 Design
| Study Type : | Observational |
| Estimated Enrollment : | 50 participants |
| Observational Model: | Case-Only |
| Time Perspective: | Prospective |
| Official Title: | Gastric Cancer Enhanced Recovery After Surgery Pathway |
| Actual Study Start Date : | October 11, 2018 |
| Estimated Primary Completion Date : | December 31, 2022 |
| Estimated Study Completion Date : | December 31, 2022 |
Arms and Interventions
| Group/Cohort | Intervention/treatment |
|---|---|
|
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
Complete standard of care enhanced recovery after surgery protocol
Other Names:
Other: Quality-of-Life Assessment Ancillary studies
Other Name: Quality of Life Assessment
Other: Questionnaire Administration Ancillary studies
|
Outcome Measures
Primary Outcome Measures :
- 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 ]
Secondary Outcome Measures :
- 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 ]EORTC QLQ-C30 questionnaires to measure Quality of life
- 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 ]STO22 questionnaires to measure stomach cancer surgery related QoL
Other Outcome Measures:
- Ambulation [ Time Frame: From time of surgery to first postoperative clinic visit, assessed up to 30 days ]Number of steps taken after surgery as measured by a podometer
- Immune biomarkers [ Time Frame: 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 ]Blood levels of hsCRP will be measured before and after surgery to determine its relationship to complications and recurrence
- Disease free survival of enrolled patients [ Time Frame: Up to 14 months after surgery ]
- Overall survival of enrolled patients [ Time Frame: Up to 14 months after surgery ]
Eligibility Criteria
| Ages Eligible for Study: | 18 Years to 99 Years (Adult, Older Adult) |
| Sexes Eligible for Study: | All |
| Accepts Healthy Volunteers: | No |
| 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
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.
Contacts and Locations
Locations
| United States, California | |
| City of Hope Medical Center | Recruiting |
| Duarte, California, United States, 91010 | |
| Contact: Yanghee Woo 626-218-7100 ywoo@coh.org | |
| Principal Investigator: Yanghee Woo | |
Sponsors and Collaborators
City of Hope Medical Center
National Cancer Institute (NCI)
Investigators
| Principal Investigator: | Yanghee Woo | City of Hope Medical Center |
| Tracking Information | |||||||
|---|---|---|---|---|---|---|---|
| First Submitted Date | August 6, 2018 | ||||||
| First Posted Date | June 25, 2019 | ||||||
| Last Update Posted Date | March 10, 2021 | ||||||
| Actual Study Start Date | October 11, 2018 | ||||||
| Estimated Primary Completion Date | December 31, 2022 (Final data collection date for primary outcome measure) | ||||||
| Current Primary Outcome Measures |
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| Original Primary Outcome Measures | Same as current | ||||||
| Change History | |||||||
| Current Secondary Outcome Measures |
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| Original Secondary Outcome Measures | Same as current | ||||||
| Current Other Pre-specified Outcome Measures |
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| Original Other Pre-specified Outcome Measures | Same as current | ||||||
| Descriptive Information | |||||||
| Brief Title | 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 | ||||||
| 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. |
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| Study Type | Observational | ||||||
| Study Design | Observational Model: Case-Only Time Perspective: Prospective |
||||||
| Target Follow-Up Duration | Not Provided | ||||||
| Biospecimen | Not Provided | ||||||
| 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 | ||||||
| Condition |
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| Intervention |
|
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| Study Groups/Cohorts | Observational (ERAS protocol)
Participants complete standard of care early recovery after surgery protocol beginning the day before surgery to day 6 after surgery.
Interventions:
|
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| Publications * | Not Provided | ||||||
|
* Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline. |
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| Recruitment Information | |||||||
| Recruitment Status | Recruiting | ||||||
| Estimated Enrollment |
50 | ||||||
| Original Estimated Enrollment | Same as current | ||||||
| Estimated Study Completion Date | December 31, 2022 | ||||||
| Estimated Primary Completion Date | December 31, 2022 (Final data collection date for primary outcome measure) | ||||||
| Eligibility Criteria |
Inclusion Criteria:
Exclusion Criteria:
|
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| Sex/Gender |
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| Ages | 18 Years to 99 Years (Adult, Older Adult) | ||||||
| Accepts Healthy Volunteers | No | ||||||
| Contacts | |||||||
| Listed Location Countries | United States | ||||||
| Removed Location Countries | |||||||
| Administrative Information | |||||||
| NCT Number | NCT03997162 | ||||||
| Other Study ID Numbers | 17482 NCI-2018-01639 ( Registry Identifier: CTRP (Clinical Trial Reporting Program) ) 17482 ( Other Identifier: City of Hope Comprehensive Cancer Center ) |
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| Has Data Monitoring Committee | Yes | ||||||
| U.S. FDA-regulated Product |
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| IPD Sharing Statement | Not Provided | ||||||
| Responsible Party | City of Hope Medical Center | ||||||
| Study Sponsor | City of Hope Medical Center | ||||||
| Collaborators | National Cancer Institute (NCI) | ||||||
| Investigators |
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| PRS Account | City of Hope Medical Center | ||||||
| Verification Date | March 2021 | ||||||
