Extensive Intraoperative Peritoneal Lavage After Curative Gastrectomy for Locally Advanced Gastric Cancer (SEIPLUS)

Gastric Cancer Clinical Trial

— SEIPLUS  

Official title:

A Prospective, Multicentral, Open-label, Randomized, Controlled Clinical Trial to Investigation the Value of Extensive Intraoperative Peritoneal Lavage After Curative Gastrectomy for Locally Advanced Gastric Cancer

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT02745509
• Other study ID #: SEIPLUS
• Status: Completed
• Phase: N/A
• Start date: March 2016
• Est. completion date: November 2017

Study information

• Verified date: February 2019
• Source: Sun Yat-sen University
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

The investigators study aims to explore the potential function of extensive intraoperative peritoneal lavage in improving the overall survival and progression-free survival for locally advanced gastric cancer after curative resection.

Hypothesis: Overall survival and progression-free survival of locally advanced gastric cancer are improved by extensive intraoperative peritoneal lavage.

Description:

Gastric cancer has been one of the most frequently common cancers and remains the third leading cause of death among malignant tumors all over the world. Surgery has always been considered as the most effective treatment. While significant surgical technique and perioperative management have dramatically improved the survival of patients with advanced gastric cancer, patients with T4 stage or serosal-positive gastric cancer often suffer from recurrence as peritoneal dissemination, and the prognosis of those patients is extremely poor. Despite curatively resected, Peritoneal metastasis is completed by the implantation of peritoneal free cancer cells exfoliated from serosa-invasive tumors. Therefore, things need to be done to eliminate the free exfoliated cancer cells on the peritoneal lining in order to reduce the risk of peritoneal recurrence.

A multi-institutional prospective, randomized trial has been launched by Kuramoto recently. The trail was intended to demonstrate the superiority in overall survival of addition of Extensive Intraoperative peritoneal Lavage (EIPL) to standard treatment in patients with≥T3 carcinoma of stomach. Based on the'limiting dilution theory', after total or distal gastrectomy with D2 lymphadenectomy, the peritoneal cavity is extensively rinsed 10 times with 1 L physiological saline at a time, followed by complete aspiration of the fluid. In total, 10 L saline is to be used. In this study, the EIPL-IPC group had a significantly lower incidence of peritoneal recurrence. Furthermore, the 5-year overall survival rate of the patients in the EIPL-IPC group (43.8%) was significantly better than that of the intraperitoneal chemotherapy (IPC) group (4.6%) and the surgery-alone group (0%). All in all, EIPL is easy to carry out, safe and inexpensive. Therefore, gastrectomy with EIPL will be a new standard treatment of gastric cancer.

To ensure the quality of the study, two interim analyses will be planned at the half and the completion of the study respectively. The Data and Safety Monitoring Committee will independently review the interim analysis and stop the study ahead of schedule if necessary. Furthermore, to improve the study progress and quality, the in-house interim monitoring will be performed.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 508
• Est. completion date: November 2017
• Est. primary completion date: November 2017
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years to 80 Years

Eligibility

Inclusion Criteria:

1. Lower age limit of research subjects 18 years old and upper age limit of 80 years old.

2. ECOG score standard (ECOG)performance status of 0 or 1 and expected to survive more than 6 months.

3. Without any other malignancies.

4. Written informed consent from the patient.

5. Histologically proven primary gastric adenocarcinoma.

6. Patients planned for open gastrectomy.

7. Patients who have T3 (subserosal) or T4 (serosal) disease based on Ultrasound gastroscopy and intra-operative inspection with any N staging and M0 gastric cancer.

8. No preoperative neoadjuvant chemotherapy.

9. Length of esophageal invasion=3cm and no need of thoracotomy for resection.

10. Intraoperative inclusion criteria:

1. Clinically T3, T4a or T4b.

2. Clinically H0 and M0. No peritoneal dissemination or Distant metastases.

3. Possible for R0 surgery.

Exclusion Criteria:

1. Female in pregnancy or lactation.

2. Supraclavicular lymph nodes metastases,pelvis or ovarian implantation,peritoneal dissemination,liver,lung and bone metastases.

3. Massive ascites or cachexia.

4. Patients participating in any other clinical trails currently,or participated in other trails within 1 months.

5. Without a history of stomach or esophageal cancers, including stromal tumor,sarcoma,lymphoma and carcinoid.

6. Suffering from other serious diseases, including cardiovascular, respiratory, kidney, or liver disease, complicated by poorly controlled hypertension, diabetes, mental disorders or diseases.

7. Patients with poor compliance or considered to be poor compliance.

Related Conditions & MeSH terms

• Gastric Cancer
• Stomach Neoplasms

Intervention

Other:
• Extensive Intraoperative Peritoneal Lavage
Extensive Intraoperative Peritoneal Lavage

Locations

Country	Name	City	State
China	Anqing Municipal Hospital	Anqing	Anhui
China	Cancer Center of Sun Yat-sen University	Guangzhou	Guangdong
China	Guangdong Provincial Hospital of Traditional Chinese Medicine	Guangzhou	Guangdong
China	The First Affiliated Hospital of Guangdong Pharmaceutical University	Guangzhou	Guangdong
China	Yuebei People's Hospital	Guangzhou	Guangdong
China	Second Affiliated Hospital, School of Medicine, Zhejiang University	Hangzhou	Zhejiang
China	Anhui Provincial Hospital	Hefei	Anhui
China	The First Affiliated Hospital of Anhui Medical University	Hefei	Anhui
China	Lishui Hospital of Zhejiang University	Lishui	Zhejiang
China	Jiangxi Provincial Cancer Hospital	Nanchang	Jiangxi
China	Jiangsu Cancer Institute & Hospital	Nanjing	Jiangsu
China	Tianjin Medical University Cancer Institute and Hospital	Tianjin
China	First Affiliated Hospital of Wannan Medical College	Wuhu	Anhui

Sponsors (13)

Lead Sponsor

Collaborator

Sun Yat-sen University

Anhui Provincial Hospital, Anqing Municipal Hospital, First Affiliated Hospital of Wannan Medical College, Guangdong Provincial Hospital of Traditional Chinese Medicine, Jiangsu Cancer Institute & Hospital, Jiangxi Provincial Cancer Hospital, Lishui hospital of Zhejiang University, Second Affiliated Hospital, School of Medicine, Zhejiang University, The First Affiliated Hospital of Anhui Medical University, The First Affiliated Hospital of Guangdong Pharmaceutical University, Tianjin Medical University Cancer Institute and Hospital, Yuebei People's Hospital

Country where clinical trial is conducted

China, 

References & Publications (9)

Coccolini F, Cotte E, Glehen O, Lotti M, Poiasina E, Catena F, Yonemura Y, Ansaloni L. Intraperitoneal chemotherapy in advanced gastric cancer. Meta-analysis of randomized trials. Eur J Surg Oncol. 2014 Jan;40(1):12-26. doi: 10.1016/j.ejso.2013.10.019. Epub 2013 Nov 5. Review. — View Citation

Hamazoe R, Maeta M, Kaibara N. Intraperitoneal thermochemotherapy for prevention of peritoneal recurrence of gastric cancer. Final results of a randomized controlled study. Cancer. 1994 Apr 15;73(8):2048-52. — View Citation

Kuramoto M, Shimada S, Ikeshima S, Matsuo A, Yagi Y, Matsuda M, Yonemura Y, Baba H. Extensive intraoperative peritoneal lavage as a standard prophylactic strategy for peritoneal recurrence in patients with gastric carcinoma. Ann Surg. 2009 Aug;250(2):242-6. doi: 10.1097/SLA.0b013e3181b0c80e. — View Citation

Mezhir JJ, Posner MC, Roggin KK. Prospective clinical trial of diagnostic peritoneal lavage to detect positive peritoneal cytology in patients with gastric cancer. J Surg Oncol. 2013 Jun;107(8):794-8. doi: 10.1002/jso.23328. Epub 2013 Mar 26. — View Citation

Misawa K, Mochizuki Y, Ohashi N, Matsui T, Nakayama H, Tsuboi K, Sakai M, Ito S, Morita S, Kodera Y. A randomized phase III trial exploring the prognostic value of extensive intraoperative peritoneal lavage in addition to standard treatment for resectable advanced gastric cancer: CCOG 1102 study. Jpn J Clin Oncol. 2014 Jan;44(1):101-3. doi: 10.1093/jjco/hyt157. Epub 2013 Nov 27. — View Citation

Rosen HR, Jatzko G, Repse S, Potrc S, Neudorfer H, Sandbichler P, Zacherl J, Rabl H, Holzberger P, Lisborg P, Czeijka M. Adjuvant intraperitoneal chemotherapy with carbon-adsorbed mitomycin in patients with gastric cancer: results of a randomized multicenter trial of the Austrian Working Group for Surgical Oncology. J Clin Oncol. 1998 Aug;16(8):2733-8. — View Citation

Sautner T, Hofbauer F, Depisch D, Schiessel R, Jakesz R. Adjuvant intraperitoneal cisplatin chemotherapy does not improve long-term survival after surgery for advanced gastric cancer. J Clin Oncol. 1994 May;12(5):970-4. — View Citation

Tang B, Peng ZH, Yu PW, Yu G, Qian F, Zeng DZ, Zhao YL, Shi Y, Hao YX, Luo HX. Aberrant expression of Cx43 is associated with the peritoneal metastasis of gastric cancer and Cx43-mediated gap junction enhances gastric cancer cell diapedesis from peritoneal mesothelium. PLoS One. 2013 Sep 11;8(9):e74527. doi: 10.1371/journal.pone.0074527. eCollection 2013. — View Citation

Xu DZ, Zhan YQ, Sun XW, Cao SM, Geng QR. Meta-analysis of intraperitoneal chemotherapy for gastric cancer. World J Gastroenterol. 2004 Sep 15;10(18):2727-30. — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Overall survival	The survival rate between the surgery to the 3rd year due to all-cause death or last follow-up.	3-year
Secondary	Disease-free survival	The progression-free or all-cause death rate between the surgery and the 3rd year.	3-year
Secondary	Peritoneal recurrence	The Peritoneal recurrence rate between the surgery and the 3rd year	3-year
Secondary	Postoperative complications	complications such bleeding, infection, obstruction and leakage	an average of 10 days
Secondary	Post-operative quality of life	The postoperative quality of life will be assessed by factors such as Swallowing,Pain and discomfort,Dietary restrictions, Upper gastrointestinal symptoms, mental status and others.	an average of 10 days

External Links

•   Cancer
•   Genetic and Rare Diseases Information Center
•   Stomach Cancer
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