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Completed

NCT Number: NCT04879953

Effect of the PIPAC on the Survival Rate of Patients With Peritoneal Carcinomatosis of Gastric Origin

Pressurised intraperitoneal aerosol chemotherapy is a new surgical technique, developed for the treatment of initially unresectable peritoneal carcinomatosis. The objective of this study was to compare the results of PIPAC associated with systemic chemotherapy with those of systemic chemotherapy alone in patients with gastric peritoneal carcinomatosis without metastasis other than peritoneal, and WHO performance status <3.

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Key information

Conditions

Carcinomatosis, Peritoneal Abdominal Neoplasms Digestive System Diseases Digestive System Neoplasms Neoplasms Neoplasms by Site Peritoneal Diseases Peritoneal Neoplasms

Age range

18 year and older

Sex eligibility

All sexes

Study type

Observational

Primary location

CHUGA

Grenoble, France

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • Patients 18 years or over
  • Patients with adenocarcinoma-type gastric non-resectable péritonéale carcinomatosis.
  • Patients without metastasis other than peritoneal.
  • WHO performance status <3
  • Patients treated either with PIPAC administered in alternation with systemic chemotherapy (PIPAC_CHEM) or by systemic chemotherapy alone (ONLY_CHEM)
  • Patient informed

Exclusion criteria

  • Patients opposed

Treatment and study plan

PIPAC with systemic chemotherapy

Drug

PIPAC procedures were performed every 6 to 8 weeks, alternating with systemic chemotherapy, replacing a cycle of intravenous chemotherapy.

Systemic chemotherapy alone

Drug

Intravenous chemotherapy

Primary outcomes

  1. Overall survival at 6 months

    Time frame: 6 months

    Overall survival at 6 months from diagnosis of carcinomatosis

Secondary outcomes

  1. Duration of hospital stay

    Time frame: 6 months

    duration of hospitalization up to 6 months after the diagnosis of carcinomatosis

  2. overall survival from the diagnosis of carcinomatosis and from the diagnosis of the primary tumour.

    Time frame: 3 years

    overall survival throughout the study follow-up from the diagnosis of carcinomatosis and from the diagnosis of the primary tumour.

Sponsors and collaborators

Lead sponsor

Association Francaise de Chirurgie

Other

Registry information

Official study title

Effect of Pressurised Intraperitoneal Aerosol Chemotherapy on the Survival Rate of Patients With Peritoneal Carcinomatosis of Gastric Origin

Important dates

Study start
2020
Primary completion
2020
Study completion
2020
First posted
May 10, 2021
Registry last updated
May 11, 2021

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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