Significance of Circulating Tumor Cells in the Treatment of Gastric and Rectal Cancer

Not Applicable

Completed

• Conditions: Circulating Tumor Cells; Gastric Cancer; Colorectal Cancer
• Interventions: Procedure: Surgery

• Registration Number: NCT02955173
• Lead Sponsor: Qilu Hospital of Shandong University

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.

Detailed Description

Laparoscopic surgery represents a milestone for treatment of gastric and rectal cancer, with advantages of minimal invasion and rapid recovery compared to open approach. However, for progressive gastric and rectal cancer, laparoscopic approach has not been officially promoted by NCCN guideline (2015).

Over the past decade, circulating tumor cells (CTCs), originated from a tumor cell, have been identified as potential blood-based biomarkers capable of providing prognostic and predictive Information.

In the present study, the investigators utilize the CTCBIOPSY® system (YZYBIO Company, Wuhan, China), which has been approved by CFDA (Chinese Food and Drug Administration), to detect CTCs, and try 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.

Study Timeline

• Study First Submitted: 2016-11-02
• Study First Submitted QC: 2016-11-03
• Study First Posted: 2016-11-04
• Study Start: 2016-12
• Primary Completion: 2020-12-14
• Study Completion: 2021-08-03
• Status Verified: 2021-10
• Last Update Submitted: 2021-10-02
• Last Update Posted: 2021-10-05

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 467

Inclusion Criteria

• Gastric cancer of stage II/III

Exclusion Criteria

• History of malignant tumors
• Gastric cancer of stage Ⅳ
• Preoperative neoadjuvant chemotherapy
• History of upper abdominal surgery
• Severe other contradictions of surgery

Rectal cancer

Inclusion Criteria:

• Primary rectal carcinoma
• Single lesion
• No metastasis
• Sphincter-saving surgery available

Exclusion Criteria:

• 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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Laparoscopic surgery of rectal cancer	Surgery	Patients undergoing rectal cancer resection in a laparoscopic approach
Open surgery of rectal cancer	Surgery	Patients undergoing rectal cancer resection in an open approach
Open surgery of gastric cancer	Surgery	Patients undergoing gastric cancer resection in an open approach
Laparoscopic surgery of gastric cancer	Surgery	Patients undergoing gastric cancer resection in a laparoscopic approach

Primary Outcome Measures

Name	Time	Method
Disease-free survival	Two years

Secondary Outcome Measures

Name	Time	Method
Circulating tumor cell (CTC) test	Two years

Trial Locations

Locations (1)

Qilu Hospital of Shandong University; 🇨🇳 Jinan, Shandong, China