NCT02955173

Brief Summary

The primary purpose of this study is to compare both short-term and long-term treatment effect of laparoscopic vs. open approach on progressive gastric and rectal cancer, based on circulating tumor cell (CTC) test results as well as disease-free survivals, and figure out principles of laparoscopic approach for progressive gastric and rectal cancer. Secondary purpose is to establish an evaluation system for laparoscopic surgery for progressive gastric and rectal cancer treatment using CTC as a biomarker.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
467

participants targeted

Target at P75+ for not_applicable

Timeline
Completed

Started Dec 2016

Longer than P75 for not_applicable

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

November 2, 2016

Completed
2 days until next milestone

First Posted

Study publicly available on registry

November 4, 2016

Completed
27 days until next milestone

Study Start

First participant enrolled

December 1, 2016

Completed
4 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

December 14, 2020

Completed
8 months until next milestone

Study Completion

Last participant's last visit for all outcomes

August 3, 2021

Completed
Last Updated

October 5, 2021

Status Verified

October 1, 2021

Enrollment Period

4 years

First QC Date

November 2, 2016

Last Update Submit

October 2, 2021

Conditions

Circulating Tumor CellsColorectal CancerGastric Cancer

Outcome Measures

Primary Outcomes (1)

  • Disease-free survival

    Two years

Secondary Outcomes (1)

  • Circulating tumor cell (CTC) test

    Two years

Study Arms (4)

Open surgery of rectal cancer

EXPERIMENTAL

Patients undergoing rectal cancer resection in an open approach

Procedure: Surgery

Laparoscopic surgery of rectal cancer

EXPERIMENTAL

Patients undergoing rectal cancer resection in a laparoscopic approach

Procedure: Surgery

Open surgery of gastric cancer

EXPERIMENTAL

Patients undergoing gastric cancer resection in an open approach

Procedure: Surgery

Laparoscopic surgery of gastric cancer

EXPERIMENTAL

Patients undergoing gastric cancer resection in a laparoscopic approach

Procedure: Surgery

Interventions

SurgeryPROCEDURE

Laparoscopic or open surgery for resection of gastric or rectal cancer

Laparoscopic surgery of gastric cancerLaparoscopic surgery of rectal cancerOpen surgery of gastric cancerOpen surgery of rectal cancer

Eligibility Criteria

Age18 Years - 80 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • Gastric cancer of stage II/III

You may not qualify if:

  • History of malignant tumors
  • Gastric cancer of stage â…£
  • Preoperative neoadjuvant chemotherapy
  • History of upper abdominal surgery
  • Severe other contradictions of surgery
  • Rectal cancer
  • Primary rectal carcinoma
  • Single lesion
  • No metastasis
  • Sphincter-saving surgery available
  • History of malignant tumors
  • Acute bowel obstruction, bleeding or perforation
  • Tumor over 6cm in diameter or in severe adhesion with surrounded tissues
  • Severe other contradictions of surgery

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Qilu Hospital of Shandong University

Jinan, Shandong, 250012, China

Location

Related Publications (2)

  • Benson AB 3rd, Venook AP, Bekaii-Saab T, Chan E, Chen YJ, Cooper HS, Engstrom PF, Enzinger PC, Fenton MJ, Fuchs CS, Grem JL, Grothey A, Hochster HS, Hunt S, Kamel A, Kirilcuk N, Leong LA, Lin E, Messersmith WA, Mulcahy MF, Murphy JD, Nurkin S, Rohren E, Ryan DP, Saltz L, Sharma S, Shibata D, Skibber JM, Sofocleous CT, Stoffel EM, Stotsky-Himelfarb E, Willett CG, Gregory KM, Freedman-Cass D. Rectal Cancer, Version 2.2015. J Natl Compr Canc Netw. 2015 Jun;13(6):719-28; quiz 728. doi: 10.6004/jnccn.2015.0087.

    PMID: 26085388BACKGROUND

  • Lowes LE, Bratman SV, Dittamore R, Done S, Kelley SO, Mai S, Morin RD, Wyatt AW, Allan AL. Circulating Tumor Cells (CTC) and Cell-Free DNA (cfDNA) Workshop 2016: Scientific Opportunities and Logistics for Cancer Clinical Trial Incorporation. Int J Mol Sci. 2016 Sep 8;17(9):1505. doi: 10.3390/ijms17091505.

    PMID: 27618023BACKGROUND

Related Links

MeSH Terms

Conditions

Neoplastic Cells, CirculatingColorectal NeoplasmsStomach Neoplasms

Interventions

Surgical Procedures, Operative

Condition Hierarchy (Ancestors)

Neoplasm MetastasisNeoplastic ProcessesNeoplasmsPathologic ProcessesPathological Conditions, Signs and SymptomsIntestinal NeoplasmsGastrointestinal NeoplasmsDigestive System NeoplasmsNeoplasms by SiteDigestive System DiseasesGastrointestinal DiseasesColonic DiseasesIntestinal DiseasesRectal DiseasesStomach Diseases

Study Officials

  • Sanyuan Hu, M.D. Ph.D.

    Qilu Hospital of Shandong University

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
NON RANDOMIZED
Masking
SINGLE
Who Masked
OUTCOMES ASSESSOR
Purpose
SCREENING
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Dr.& Prof.

Study Record Dates

First Submitted

November 2, 2016

First Posted

November 4, 2016

Study Start

December 1, 2016

Primary Completion

December 14, 2020

Study Completion

August 3, 2021

Last Updated

October 5, 2021

Record last verified: 2021-10

Data Sharing

IPD Sharing
Will not share

Locations

CN(1)