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

NCT ID: NCT03253939

Last Updated: 2017-08-18

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Total Enrollment

275 participants

Study Classification

OBSERVATIONAL

Study Start Date

2017-02-01

Study Completion Date

2017-07-01

Brief Summary

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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.

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Detailed Description

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Conditions

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Gastric Cancer Peritoneal Carcinomatosis

Study Design

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Observational Model Type

CASE_CONTROL

Study Time Perspective

RETROSPECTIVE

Study Groups

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Case group

Cytoreductive surgery combined with hyperthermic intraperitoneal chemotherapy procedure

Cytoreductive surgery combined with hyperthermic intraperitoneal chemotherapy procedure

Intervention Type PROCEDURE

Cytoreductive surgery combined with hyperthermic intraperitoneal chemotherapy procedure

Control group

Cytoreductive surgery alone

Cytoreductive surgery alone

Intervention Type PROCEDURE

Exclusively Cytoreductive surgery approach

Interventions

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Cytoreductive surgery combined with hyperthermic intraperitoneal chemotherapy procedure

Cytoreductive surgery combined with hyperthermic intraperitoneal chemotherapy procedure

Intervention Type PROCEDURE

Cytoreductive surgery alone

Exclusively Cytoreductive surgery approach

Intervention Type PROCEDURE

Eligibility Criteria

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Inclusion Criteria

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

Exclusion Criteria

\- Gastric origin of peritoneal carcinomatosis unconfirmed
Minimum Eligible Age

18 Years

Maximum Eligible Age

95 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Hospices Civils de Lyon

OTHER

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Locations

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

Pierre-Bénite, , France

Site Status

Countries

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France

References

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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.

Reference Type DERIVED
PMID: 31084544 (View on PubMed)

Other Identifiers

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CYTO-CHIP

Identifier Type: -

Identifier Source: org_study_id

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