Cytoreductive Surgery and Hyperthermic Intraperitoneal Chemotherapy in Peritoneal Carcinomatosis From Gastric Cancer

NCT03253939 | Completed

• 1 other identifier: CYTO-CHIP
• Study Type: observational
• Target: 275
• Locations: 1 country
• Sites: 1

Brief Summary

Gastric cancer associated peritoneal carcinomatosis has a poor prognosis with a median survival of less than one year. Systemic chemotherapy including targeted agents has not been found to significantly increase the survival in Gastric cancer associated peritoneal carcinomatosis. Since recurrent gastric cancer remains confined to the abdominal cavity in many patients, regional therapies like aggressive cytoreductive surgery and hyperthermic intraperitoneal chemotherapy have been investigated for Gastric cancer associated peritoneal carcinomatosis. Hyperthermic intraperitoneal chemotherapy has been used for three indications in Gastric Cancer- as an adjuvant therapy after a curative surgery, hyperthermic intraperitoneal chemotherapy has been shown to improve survival and reduce peritoneal recurrences in many randomised trials in Asian countries; as a definitive treatment in established PC, hyperthermic intraperitoneal chemotherapy along with cytoreductive surgery is the only therapeutic modality that has resulted in long-term survival in select groups of patients. While the results of randomised trials of adjuvant hyperthermic intraperitoneal chemotherapy from western centres are awaited, the role of hyperthermic intraperitoneal chemotherapy in the treatment of Gastric cancer associated peritoneal carcinomatosis is still evolving and needs larger studies before it is accepted as a standard of care.

Conditions

Gastric Cancer; Peritoneal Carcinomatosis

Outcome Measures

Primary Outcomes (1)

• 3-years overall survival

  From the date of Cytoreductive surgery + hyperthermic intraperitoneal chemotherapy to death or to the end of follow-up

  3 years

Study Arms (2)

Case group

Cytoreductive surgery combined with hyperthermic intraperitoneal chemotherapy procedure

Procedure: Cytoreductive surgery combined with hyperthermic intraperitoneal chemotherapy procedure

Control group

Cytoreductive surgery alone

Procedure: Cytoreductive surgery alone

Interventions

Cytoreductive surgery combined with hyperthermic intraperitoneal chemotherapy procedure PROCEDURE

Cytoreductive surgery combined with hyperthermic intraperitoneal chemotherapy procedure

Case group

Cytoreductive surgery alone PROCEDURE

Exclusively Cytoreductive surgery approach

Control group

Eligibility Criteria

• Age: 18 Years - 95 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

Study Population

Patients with gastric peritoneal carcinomatosis. All patients received the current standard neoadjuvant treatment.

You may qualify if:

• Confirmed peritoneal carcinomatosis from gastric cancer
• Metachronous/synchronous peritoneal carcinomatosis

You may not qualify if:

• \- Gastric origin of peritoneal carcinomatosis unconfirmed

Sponsors & Collaborators

• Hospices Civils de Lyon: lead

Study Sites (1)

Service de Chirurgie Générale et Digestive - Centre Hospitalier Lyon Sud - Hospices Civils de Lyon

Pierre-Bénite, 69495, France

Location

Related Publications (1)

• Bonnot PE, Piessen G, Kepenekian V, Decullier E, Pocard M, Meunier B, Bereder JM, Abboud K, Marchal F, Quenet F, Goere D, Msika S, Arvieux C, Pirro N, Wernert R, Rat P, Gagniere J, Lefevre JH, Courvoisier T, Kianmanesh R, Vaudoyer D, Rivoire M, Meeus P, Passot G, Glehen O; FREGAT and BIG-RENAPE Networks. Cytoreductive Surgery With or Without Hyperthermic Intraperitoneal Chemotherapy for Gastric Cancer With Peritoneal Metastases (CYTO-CHIP study): A Propensity Score Analysis. J Clin Oncol. 2019 Aug 10;37(23):2028-2040. doi: 10.1200/JCO.18.01688. Epub 2019 May 14.

  PMID: 31084544 DERIVED

MeSH Terms

Conditions

Stomach Neoplasms; Peritoneal Neoplasms

Interventions

Cytoreduction Surgical Procedures

Condition Hierarchy (Ancestors)

Gastrointestinal Neoplasms; Digestive System Neoplasms; Neoplasms by Site; Neoplasms; Digestive System Diseases; Gastrointestinal Diseases; Stomach Diseases; Abdominal Neoplasms; Peritoneal Diseases

Intervention Hierarchy (Ancestors)

Surgical Procedures, Operative

Study Design

• Study Type: observational
• Observational Model: CASE CONTROL
• Time Perspective: RETROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: July 27, 2017
• First Posted: August 18, 2017
• Study Start: February 1, 2017
• Primary Completion: July 1, 2017
• Study Completion: July 1, 2017
• Last Updated: August 18, 2017

Record last verified: 2017-07

Data Sharing

• IPD Sharing: Will not share

Locations

FR (1)