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

Shandong University

Status: Completed

Conditions: Gastric Cancer; Colorectal Cancer; Circulating Tumor Cells

Treatments: Procedure: Surgery

Study type: Interventional

Funder types: Other

Identifiers

NCT02955173

2016YFC0106003

Details and patient eligibility

About

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.

Full 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.

Enrollment: 467 patients

Sex: All

Ages: 18 to 80 years old

Volunteers: No Healthy Volunteers

Inclusion and exclusion criteria

Gastric cancer

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

Trial design

Primary purpose: Screening

Allocation: Non-Randomized

Interventional model: Parallel Assignment

Masking: Single Blind

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467 participants in 4 patient groups

Open surgery of rectal cancer

Experimental group

Description:

Patients undergoing rectal cancer resection in an open approach

Treatment:

Procedure: Surgery

Laparoscopic surgery of rectal cancer

Experimental group

Description:

Patients undergoing rectal cancer resection in a laparoscopic approach

Treatment:

Procedure: Surgery

Open surgery of gastric cancer

Experimental group

Description:

Patients undergoing gastric cancer resection in an open approach

Treatment:

Procedure: Surgery

Laparoscopic surgery of gastric cancer

Experimental group

Description:

Patients undergoing gastric cancer resection in a laparoscopic approach

Treatment:

Procedure: Surgery