Efficacy and feasibility of pasireotide to reduce clinically relevant digestive leakage after complete cytoreductive surgery (CRS) plus Hyperthermic Intra-Peritoneal Chemotherapy (HIPEC) for peritoneal carcinomatosis

Phase 1

• Conditions: Primary and secondary peritoneal malignancies; MedDRA version: 20.0Level: LLTClassification code 10068069Term: Peritoneal carcinomatosisSystem Organ Class: 100000004864; MedDRA version: 20.1Level: PTClassification code 10080244Term: Peritoneal cancer indexSystem Organ Class: 10022891 - Investigations; Therapeutic area: Diseases [C] - Cancer [C04]

• Registration Number: EUCTR2019-002507-18-FR
• Lead Sponsor: Gustave Roussy

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Results First Posted: 1900-01-01
• Study Start: 2019-11-05
• Last Update Posted: 19 February 2024

Recruitment & Eligibility

• Status: ot Recruiting
• Sex: All
• Target Recruitment: 217

Inclusion Criteria

•Male or female patients aged 18 years or greater
•ECOG (Eastern Cooperative Oncology Group) Performance Status = 2
•Primary (pseudomyxoma peritonei, peritoneal mesothelioma) or Secondary (colorectal or ovarian) peritoneal malignancies
•Curative intent resection obtained by a complete resection according to the Completeness of Cytoreduction score (CC) (CC 0-1) followed by HIPEC
Different intraperitoneal drug administration modalities such as neoadjuvant systemic plus simultaneous intraperitoneal and intravenous chemotherapy (NIPS) or pressurized intra-peritoneal aerosol chemotherapy (PIPAC) does not represent exclusion criteria.
•Absence of extra-peritoneal metastatic disease or limited hepatic or lung metastases easily amenable to curative-intent resection or ablation
•Intraoperative Peritoneal Cancer Index (PCI score) = 10
•Visceral resection with at least one digestive anastomosis with or without loop ileostomy or pancreatic or biliary resection
•Negative serum pregnancy test for women of childbearing potential within 7 days prior to therapy
•Sexually active women of childbearing potential must agree to use a highly effective method of contraception or to abstain from sexual activity during the study and for 3 months after the last study treatment administration. Sexually active males patients must agree to use condom or to abstain from sexual activity during the study and for 3 months after the last study treatment administration. Also, it is recommended their women of childbearing potential partner use a highly effective method of contraception
•Patient should understand, sign, and date the written informed consent form prior to any protocol-specific procedures performed. Patient should be able and willing to comply with study visits and procedures as per protocol.
•Patients must be affiliated to a social security system or beneficiary of the same

Are the trial subjects under 18? no
Number of subjects for this age range:
F.1.2 Adults (18-64 years) yes
F.1.2.1 Number of subjects for this age range 163
F.1.3 Elderly (>=65 years) yes
F.1.3.1 Number of subjects for this age range 54

Exclusion Criteria

•Macroscopically incomplete surgical resection (CC 2)
•Standard contraindications to pasireotide:
-patients with uncontrolled diabetes mellitus or a fasting plasma glucose > 250mg/dl (14 mMol/L)
-patients who have congestive heart failure (NYHA Class III or IV), unstable angina, sustained ventricular tachycardia, ventricular fibrillation, clinically significant bradycardia including a corrected QT (QTc) interval longer than 450 msec, advanced heart block or a history of acute myocardial infarction within the six months preceding enrollment
-patients with liver disease such as severe hepatic impairment (Child Pugh C), chronic active hepatitis or chronic persistent hepatitis with abnormal coagulation (INR>1.5).
-patients with the presence of active or suspected acute or chronic uncontrolled infection
-hypersensitivity to somatostatin analogues or any component of pasireotide formulations
-patients with uncontrolled hypothyroidism
•Patients participating or who have participated to another study evaluating the effect of a new drug other than pasireotide within 1 month prior to dosing
•Patients with a history of non-compliance to medical regimens or who are considered potentially unreliable or will be unable to complete the entire study.
•Women who are pregnant or likely to be so, or who are breastfeeding
• Patient under guardianship or deprived of his liberty by a judicial or administrative decision or incapable of giving its consent

Study & Design

• Study Type: Interventional clinical trial of medicinal product
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
Main Objective: To assess the efficacy of pasireotide in the reduction of clinically relevant postoperative digestive leakage after CRS plus HIPEC compared to placebo;Secondary Objective: Compare between the two arms:<br>1. secretion-absorption digestive balance <br>2. postoperative outcomes<br>3. overall and disease-free survival<br>4. safety profile and feasibility of treatment <br>;Primary end point(s): The rate of clinically relevant (NCI CTCAE v5 = grade 3) postoperative digestive leakage at 97 days;Timepoint(s) of evaluation of this end point: 90 days after the end of treatment (=J97)

Secondary Outcome Measures

Name	Time	Method
Secondary end point(s): •Nasogastric output, duration of postoperative ileus, early functional results<br>•Overall and severe complication, length of hospital stay<br>•Overall and disease-free survivals<br>•Safety and feasibility<br>;Timepoint(s) of evaluation of this end point: During Long-Term follow up : in maximum 3 years.<br>