Significance of Circulating Tumor Cells in the Treatment of Gastric and Rectal Cancer
Study Details
Study Description
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.
| Condition or Disease | Intervention/Treatment | Phase |
|---|---|---|
|
N/A |
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 Design
Arms and Interventions
| Arm | Intervention/Treatment |
|---|---|
| Experimental: Open surgery of rectal cancer Patients undergoing rectal cancer resection in an open approach |
Procedure: Surgery
Laparoscopic or open surgery for resection of gastric or rectal cancer
|
| Experimental: Laparoscopic surgery of rectal cancer Patients undergoing rectal cancer resection in a laparoscopic approach |
Procedure: Surgery
Laparoscopic or open surgery for resection of gastric or rectal cancer
|
| Experimental: Open surgery of gastric cancer Patients undergoing gastric cancer resection in an open approach |
Procedure: Surgery
Laparoscopic or open surgery for resection of gastric or rectal cancer
|
| Experimental: Laparoscopic surgery of gastric cancer Patients undergoing gastric cancer resection in a laparoscopic approach |
Procedure: Surgery
Laparoscopic or open surgery for resection of gastric or rectal cancer
|
Outcome Measures
Primary Outcome Measures
- Disease-free survival [Two years]
Secondary Outcome Measures
- Circulating tumor cell (CTC) test [Two years]
Eligibility Criteria
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
Contacts and Locations
Locations
| Site | City | State | Country | Postal Code | |
|---|---|---|---|---|---|
| 1 | Qilu Hospital of Shandong University | Jinan | Shandong | China | 250012 |
Sponsors and Collaborators
- Qilu Hospital of Shandong University
- Peking University People's Hospital
Investigators
- Principal Investigator: Sanyuan Hu, M.D. Ph.D., Qilu Hospital of Shandong University
Study Documents (Full-Text)
None provided.More Information
Additional Information:
Publications
- 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.
- 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). pii: E1505. doi: 10.3390/ijms17091505.
- 2016YFC0106003