NCT02745509

Brief 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.

Trial Health

87
On Track

Trial Health Score

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

Enrollment
508

participants targeted

Target at P75+ for not_applicable gastric-cancer

Timeline
Completed

Started Mar 2016

Geographic Reach
1 country

13 active sites

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

Study Start

First participant enrolled

March 1, 2016

Completed
27 days until next milestone

First Submitted

Initial submission to the registry

March 28, 2016

Completed
23 days until next milestone

First Posted

Study publicly available on registry

April 20, 2016

Completed
1.5 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

November 1, 2017

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

November 1, 2017

Completed
Last Updated

February 21, 2019

Status Verified

February 1, 2019

Enrollment Period

1.7 years

First QC Date

March 28, 2016

Last Update Submit

February 20, 2019

Conditions

Gastric Cancer

Keywords

Extensive Intraoperative Peritoneal LavageEIPLGastric Cancer

Outcome Measures

Primary Outcomes (1)

  • Overall survival

    The survival rate between the surgery to the 3rd year due to all-cause death or last follow-up.

    3-year

Secondary Outcomes (4)

  • Disease-free survival

    3-year

  • Peritoneal recurrence

    3-year

  • Postoperative complications

    an average of 10 days

  • Post-operative quality of life

    an average of 10 days

Study Arms (2)

Extensive Intraoperative Peritoneal Lavage

EXPERIMENTAL

Gastrectomy with D2 lymphadenectomy is performed. The peritoneal cavity of subject will be washed with 10 liters of warmed normal saline (1 liter per cycle for 10 cycles), followed by complete aspiration of the fluid . The abdomen will be closed as per standard.

Other: Extensive Intraoperative Peritoneal Lavage

Standard Treatment

NO INTERVENTION

Gastrectomy with D2 lymphadenectomy is performed. The peritoneal lavage will be done \< 3 cycles with 3 liters or less of warmed normal saline. The abdomen will be closed as per standard.

Interventions

Extensive Intraoperative Peritoneal LavageOTHER

Extensive Intraoperative Peritoneal Lavage

Also known as: EIPL
Extensive Intraoperative Peritoneal Lavage

Eligibility Criteria

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

You may qualify if:

  • Lower age limit of research subjects 18 years old and upper age limit of 80 years old.
  • ECOG score standard (ECOG）performance status of 0 or 1 and expected to survive more than 6 months.
  • Without any other malignancies.
  • Written informed consent from the patient.
  • Histologically proven primary gastric adenocarcinoma.
  • Patients planned for open gastrectomy.
  • 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.
  • No preoperative neoadjuvant chemotherapy.
  • Length of esophageal invasion≤3cm and no need of thoracotomy for resection.
  • Clinically T3, T4a or T4b.
  • Clinically H0 and M0. No peritoneal dissemination or Distant metastases.
  • Possible for R0 surgery.

You may not qualify if:

  • Female in pregnancy or lactation.
  • Supraclavicular lymph nodes metastases，pelvis or ovarian implantation，peritoneal dissemination，liver，lung and bone metastases.
  • Massive ascites or cachexia.
  • Patients participating in any other clinical trails currently，or participated in other trails within 1 months.
  • Without a history of stomach or esophageal cancers, including stromal tumor，sarcoma，lymphoma and carcinoid.
  • Suffering from other serious diseases, including cardiovascular, respiratory, kidney, or liver disease, complicated by poorly controlled hypertension, diabetes, mental disorders or diseases.
  • Patients with poor compliance or considered to be poor compliance.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (13)

Anqing Municipal Hospital

Anqing, Anhui, China

Location

Anhui Provincial Hospital

Hefei, Anhui, China

Location

The First Affiliated Hospital of Anhui Medical University

Hefei, Anhui, China

Location

First Affiliated Hospital of Wannan Medical College

Wuhu, Anhui, China

Location

Cancer Center of Sun Yat-sen University

Guangzhou, Guangdong, China

Location

Guangdong Provincial Hospital of Traditional Chinese Medicine

Guangzhou, Guangdong, China

Location

The First Affiliated Hospital of Guangdong Pharmaceutical University

Guangzhou, Guangdong, China

Location

Yuebei People's Hospital

Guangzhou, Guangdong, China

Location

Jiangsu Cancer Institute & Hospital

Nanjing, Jiangsu, China

Location

Jiangxi Provincial Cancer Hospital

Nanchang, Jiangxi, China

Location

Second Affiliated Hospital, School of Medicine, Zhejiang University

Hangzhou, Zhejiang, China

Location

Lishui Hospital of Zhejiang University

Lishui, Zhejiang, China

Location

Tianjin Medical University Cancer Institute and Hospital

Tianjin, China

Location

Related Publications (11)

  • 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.

    PMID: 23532564BACKGROUND

  • 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.

    PMID: 24040271BACKGROUND

  • 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. doi: 10.1002/1097-0142(19940415)73:83.0.co;2-q.

    PMID: 8156509BACKGROUND

  • 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. doi: 10.3748/wjg.v10.i18.2727.

    PMID: 15309728BACKGROUND

  • 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. doi: 10.1200/JCO.1994.12.5.970.

    PMID: 8164049BACKGROUND

  • 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. doi: 10.1200/JCO.1998.16.8.2733.

    PMID: 9704725BACKGROUND

  • 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.

    PMID: 24290371BACKGROUND

  • 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.

    PMID: 19638909BACKGROUND

  • 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.

    PMID: 24287077BACKGROUND

  • Guo J, Xu A, Sun X, Zhao X, Xia Y, Rao H, Zhang Y, Zhang R, Chen L, Zhang T, Li G, Xu H, Xu D. Three-year outcomes of the randomized phase III SEIPLUS trial of extensive intraoperative peritoneal lavage for locally advanced gastric cancer. Nat Commun. 2021 Nov 15;12(1):6598. doi: 10.1038/s41467-021-26778-8.

    PMID: 34782599DERIVED

  • Guo J, Xu A, Sun X, Zhao X, Xia Y, Rao H, Zhang Y, Zhang R, Chen L, Zhang T, Li G, Xu H, Xu D. Combined Surgery and Extensive Intraoperative Peritoneal Lavage vs Surgery Alone for Treatment of Locally Advanced Gastric Cancer: The SEIPLUS Randomized Clinical Trial. JAMA Surg. 2019 Jul 1;154(7):610-616. doi: 10.1001/jamasurg.2019.0153.

    PMID: 30916742DERIVED

Related Links

MeSH Terms

Conditions

Stomach Neoplasms

Condition Hierarchy (Ancestors)

Gastrointestinal NeoplasmsDigestive System NeoplasmsNeoplasms by SiteNeoplasmsDigestive System DiseasesGastrointestinal DiseasesStomach Diseases

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
SINGLE
Who Masked
PARTICIPANT
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Study Chair

Study Record Dates

First Submitted

March 28, 2016

First Posted

April 20, 2016

Study Start

March 1, 2016

Primary Completion

November 1, 2017

Study Completion

November 1, 2017

Last Updated

February 21, 2019

Record last verified: 2019-02

Locations

CN(13)