the Optimal Surveillance Frequency for Stage II/III Gastric Cancer

NCT ID: NCT05465993

Last Updated: 2022-07-20

Basic Information

• Recruitment Status: COMPLETED
• Total Enrollment: 2311 participants
• Study Classification: OBSERVATIONAL
• Study Start Date: 2017-07-01
• Study Completion Date: 2022-07-15

Brief Summary

Due to lacking of evidence on surveillance for gastric cancer (GC), this study aimed to determine the optimal postsurgical surveillance strategy for stage II/III GC patients and compare its cost-effectiveness with traditional surveillance strategies.

Detailed Description

Background The development of existing follow-up strategies is mainly based on experts' consensus and researches on recurrence patterns due to the lack of direct evidence and unified standards. On the one hand, it is unreasonable to carry out the same postsurgical surveillance for all stage II/III GC patients. Additionally, In addition to the early detection of recurrence, the optimal follow-up strategy should also balance cost and effectiveness. There were no criteria for the arrangement of follow-up in different guidelines, and the optimal postoperative follow-up strategy for patients with stage II/III GC remains unclear.

Methods Prospectively collected data from stage II/III GC patients (n=1,661) who underwent gastrectomy at Fujian Medical University Union Hospital (FJMUUH) between January 2010 and October 2015. For external validation, two independent cohorts were included, which were composed of 380 stage II/III GC patients who underwent gastrectomy at the Mayo Clinic between July 1991 and July 2012 and 270 stage II/III GC patients at the Qinghai university affiliated hospital (QUAH) between May 2010 and Oct 2014. Random survival forest models were used to predict dynamic recurrence hazards and to construct individual surveillance strategies for stage II/III GC. Cost-effectiveness were assessed by Markov model.

Conditions

Gastric Cancer

Study Design

• Observational Model Type: COHORT
• Study Time Perspective: RETROSPECTIVE

Eligibility Criteria

Inclusion Criteria

• (1) Eastern Cooperative Oncology Group (ECOG) scores of 0 (asymptomatic) or 1 (symptomatic but completely ambulatory); (2) pathologically confirmed AGC (pStage II and III, except pT4b); (3) no distant metastasis or invasion of adjacent organs (e.g., pancreas, spleen, liver, and colon) detected intra- or post-operatively; and (4) D2 lymph node dissection of gastric cancer.

Exclusion Criteria

• (1) American Society of Anesthesiologists (ASA) grade >2; (2) remnant gastric or neuroendocrine cancer; (3) history of neoadjuvant chemotherapy; (4) palliative surgery; and (5) death within 30 days after surgery.

• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Fujian Medical University

OTHER

Sponsor Role: lead

Responsible Party

Chang-Ming Huang, Prof.

Director of gastric surgery

Responsibility Role: PRINCIPAL_INVESTIGATOR

Principal Investigators

Changming Huang, MD

Role: PRINCIPAL_INVESTIGATOR

Fujian Medical University Union Hospital

Locations

Department of Gastric Surgery

Fuzhou, Fujian, China

Countries

China

References

Wu D, Lu J, Lin J, Xu BB, Xue Z, Zheng HL, Lin GS, Huang JB, Shen LL, Zheng CH, Li P, Xie JW, Wang JB, Lin JX, Chen QY, Cao LL, Ma YB, Truty MJ, Huang CM. An international multi-institution real-world study of the optimal surveillance frequency for stage II/III gastric cancer: the more, the better? Int J Surg. 2023 Dec 1;109(12):4101-4112. doi: 10.1097/JS9.0000000000000731.

Reference Type: DERIVED

PMID: 37800589 (View on PubMed)

Other Identifiers

GCFU-01

Identifier Type: -

Identifier Source: org_study_id