Clinical trial NCT03253939: Cytoreductive Surgery and Hyperthermic Intraperitoneal Chemotherapy in Peritoneal Carcinomatosis From Gastric Cancer
Official title: Cytoreductive Surgery and Hyperthermic Intraperitoneal Chemotherapy in Peritoneal Carcinomatosis From Gastric Cancer
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Gastric Cancer
Peritoneal Carcinomatosis
Lead sponsor: Hospices Civils de Lyon
Sponsor class: OTHER
First posted: 2017-08-18
Enrollment: 275
Sex: ALL
Minimum age (years): 18
Maximum age (years): 95
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: CASE_CONTROL
Time perspective: RETROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Patients with gastric peritoneal carcinomatosis. All patients received the current standard neoadjuvant treatment.

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.


Eligibility criteria: Inclusion Criteria:

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

Exclusion Criteria:

- Gastric origin of peritoneal carcinomatosis unconfirmed

Primary outcomes:
measure: 3-years overall survival
timeFrame: 3 years
Secondary outcomes:
Other outcomes:
Locations:
city: Pierre-Bénite
country: France
facility: Service de Chirurgie Générale et Digestive - Centre Hospitalier Lyon Sud - Hospices Civils de Lyon
Study officials:
References:
citation: 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.