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Cytoreductive Surgery and Hyperthermic Intraperitoneal Chemotherapy in Peritoneal Carcinomatosis From Gastric Cancer (CYTO-CHIP)

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT03253939
Recruitment Status : Completed
First Posted : August 18, 2017
Last Update Posted : August 18, 2017
Sponsor:
Information provided by (Responsible Party):
Hospices Civils de Lyon

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.

Condition or disease Intervention/treatment
Gastric Cancer Peritoneal Carcinomatosis Procedure: Cytoreductive surgery combined with hyperthermic intraperitoneal chemotherapy procedure Procedure: Cytoreductive surgery alone

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Study Type : Observational
Actual Enrollment : 275 participants
Observational Model: Case-Control
Time Perspective: Retrospective
Official Title: Cytoreductive Surgery and Hyperthermic Intraperitoneal Chemotherapy in Peritoneal Carcinomatosis From Gastric Cancer
Actual Study Start Date : February 1, 2017
Actual Primary Completion Date : July 1, 2017
Actual Study Completion Date : July 1, 2017

Resource links provided by the National Library of Medicine


Group/Cohort Intervention/treatment
Case group
Cytoreductive surgery combined with hyperthermic intraperitoneal chemotherapy procedure
Procedure: Cytoreductive surgery combined with hyperthermic intraperitoneal chemotherapy procedure
Cytoreductive surgery combined with hyperthermic intraperitoneal chemotherapy procedure

Control group
Cytoreductive surgery alone
Procedure: Cytoreductive surgery alone
Exclusively Cytoreductive surgery approach




Primary Outcome Measures :
  1. 3-years overall survival [ Time Frame: 3 years ]
    From the date of Cytoreductive surgery + hyperthermic intraperitoneal chemotherapy to death or to the end of follow-up



Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years to 95 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Sampling Method:   Non-Probability Sample
Study Population
Patients with gastric peritoneal carcinomatosis. All patients received the current standard neoadjuvant treatment.
Criteria

Inclusion Criteria:

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

Exclusion Criteria:

- Gastric origin of peritoneal carcinomatosis unconfirmed


Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03253939


Locations
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France
Service de Chirurgie Générale et Digestive - Centre Hospitalier Lyon Sud - Hospices Civils de Lyon
Pierre-Bénite, France, 69495
Sponsors and Collaborators
Hospices Civils de Lyon

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Responsible Party: Hospices Civils de Lyon
ClinicalTrials.gov Identifier: NCT03253939    
Other Study ID Numbers: CYTO-CHIP
First Posted: August 18, 2017    Key Record Dates
Last Update Posted: August 18, 2017
Last Verified: July 2017
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Additional relevant MeSH terms:
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Stomach Neoplasms
Carcinoma
Peritoneal Neoplasms
Gastrointestinal Neoplasms
Digestive System Neoplasms
Neoplasms by Site
Neoplasms
Digestive System Diseases
Gastrointestinal Diseases
Stomach Diseases
Neoplasms, Glandular and Epithelial
Neoplasms by Histologic Type
Abdominal Neoplasms
Peritoneal Diseases