Peritoneal CarcinomatosisPhase 2PASIREOCHIPNCT04826432
Pasireotide to Reduce Clinically Relevant Digestive Leakage After Complete Cytoreductive Surgery (CRS) Plus Hyperthermic Intra-Peritoneal Chemotherapy (HIPEC) for Peritoneal Carcinomatosis
A Phase 2 study testing Pasireotide 0.9 MG/ML and Saline water in people with Peritoneal Carcinomatosis, run by Gustave Roussy, Cancer Campus, Grand Paris at 1 site in France.
Trial summary
To assess the efficacy of pasireotide in the reduction of clinically relevant postoperative digestive leakage after CRS plus HIPEC compared to placebo Read more about this study
- Who is it for?
- Ages 18 to 75 years
- Conditions the study is for
- Peritoneal Carcinomatosis
- What is being tested?
- Pasireotide 0.9 MG/ML and Saline water
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 6 participants
- Where
- 1 siteFrance
- Study dates
- 3 Sep 2020to 7 Feb 2024
- Phase
- Phase 2
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 75 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Male or female patients aged between 18 years and 75 years included
- 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
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- 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 during the same period.
- 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
Who cannot join
- 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
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- 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
- Patient who have already participated to this study (a patient can only be included once in the study)
- 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
Trial locations and contacts
1 site in 1 country.
About this study
Official title: 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 - a Phase II Randomized Multicentric Trial
To assess the efficacy of pasireotide in the reduction of clinically relevant postoperative digestive leakage after CRS plus HIPEC compared to placebo
- Conditions
- Peritoneal Carcinomatosis
- Being tested
- Pasireotide 0.9 MG/ML, Saline water
- Medical subject headings
- Peritoneal Neoplasms
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Pasireotide 0.9 MG/MLDrug
0.9 mg of pasireotide subcutaneously (s.c.) twice daily (14 doses) every 12 +/- 2 hours
Saline waterOther
0.9 ml of saline water s.c. twice daily (14 doses) every 12 +/- 2 hours
| Study group | Role | What they receive |
|---|---|---|
| Pasireotide | Experimental | 0.9 mg of pasireotide subcutaneously (s.c.) twice daily (14 doses) every 12 +/- 2 hours Receives: Drug: Pasireotide 0.9 MG/ML |
| Placebo | Placebo comparator | 0.9 ml of saline water s.c. twice daily (14 doses) every 12 +/- 2 hours Receives: Other: Saline water |
What is being measured
The primary outcome is the main question the study is designed to answer.
postoperative digestive leakage
The rate of clinically relevant (NCI CTCAE v5 ≥ grade 3) postoperative digestive leakage at 97 days
Measured: 97 days
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted1 Apr 2021
- Study start3 Sep 2020
- Primary completion7 Feb 2024
- Study completion7 Feb 2024
Why it stopped: No more experimental drugs available
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Peritoneal CarcinomatosisStudies of the same condition, open and under way.
- More trials run by Gustave Roussy, Cancer Campus, Grand ParisThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 2
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Model description
- Randomized Single-blinded, multicentric, placebo controlled phase II comparative trial
- Masking
- Single blind
- Who is masked
- Participant
- Enrolment
- 6 participants (actual)
Sponsor and investigators
- Lead sponsor
- Gustave Roussy, Cancer Campus, Grand Paris
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04826432
- Sponsor's protocol ID
- 2019-002507-18
- Other IDs
- 2019/2955, 2019
- Acronym
- PASIREOCHIP
- Status last verified
- Feb 2024
- First submitted
- 29 Mar 2021
- Last updated
- 8 Feb 2024
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided
Study at a glance
From the registry record, last updated by the sponsor on 8 Feb 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- 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 - a Phase II Randomized Multicentric Trial
- ClinicalTrials.gov ID
- NCT04826432
- Acronym / sponsor ID
- PASIREOCHIP / 2019-002507-18
- Conditions
- Peritoneal Carcinomatosis
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- TerminatedReason stopped: No more experimental drugs available
- Enrolment
- 6 participants (actual)
- Lead sponsor
- Gustave Roussy, Cancer Campus, Grand ParisUniversity, hospital or other
- Study start
- 3 Sep 2020 (actual)
- Primary completion
- 7 Feb 2024 (actual)
- Study completion
- 7 Feb 2024 (actual)
- First posted
- 1 Apr 2021 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
To assess the efficacy of pasireotide in the reduction of clinically relevant postoperative digestive leakage after CRS plus HIPEC compared to placebo
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (participant)
- Number of arms
- 2
- Model description
- Randomized Single-blinded, multicentric, placebo controlled phase II comparative trial
| Arm | Type | Receives |
|---|---|---|
| Pasireotide | Experimental | Drug: Pasireotide 0.9 MG/ML0.9 mg of pasireotide subcutaneously (s.c.) twice daily (14 doses) every 12 +/- 2 hours |
| Placebo | Placebo comparator | Other: Saline water0.9 ml of saline water s.c. twice daily (14 doses) every 12 +/- 2 hours |
Who may qualify
- Ages
- 18 to 75 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (11 listed)
- Male or female patients aged between 18 years and 75 years included
- 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
Key exclusion criteria (13 listed)
- Macroscopically incomplete surgical resection (CC 2)
- Standard contraindications to pasireotide:
- 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
- Patient who have already participated to this study (a patient can only be included once in the study)
- 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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Pasireotide 0.9 MG/ML0.9 mg of pasireotide subcutaneously (s.c.) twice daily (14 doses) every 12 +/- 2 hours | Drug | Pasireotide |
| Saline water0.9 ml of saline water s.c. twice daily (14 doses) every 12 +/- 2 hours | Other | Placebo |
Primary outcome
postoperative digestive leakage
Time frame: 97 days
The rate of clinically relevant (NCI CTCAE v5 ≥ grade 3) postoperative digestive leakage at 97 days
Results and safety
The study was stopped early (reason given: No more experimental drugs available). Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 8 Feb 2024.
- Individual participant dataSharing planned: Undecided
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 2 study testing Pasireotide 0.9 MG/ML and Saline water in people with Peritoneal Carcinomatosis, run by Gustave Roussy, Cancer Campus, Grand Paris at 1 site in France.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 11 inclusion and 13 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: stopped early, as of the sponsor's last update on 8 Feb 2024. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in France. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
The study was stopped early (reason given: No more experimental drugs available). Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
postoperative digestive leakage (time frame: 97 days). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 8 Feb 2024.