Carcinomatosis, PeritonealNCT04879953
Effect of the PIPAC on the Survival Rate of Patients With Peritoneal Carcinomatosis of Gastric Origin
An observational study of Carcinomatosis, Peritoneal, run by Association Francaise de Chirurgie at 1 site in France.
Trial summary
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… Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Carcinomatosis, Peritoneal
- What is being tested?
- PIPAC with systemic chemotherapy and Systemic chemotherapy alone
- Type of treatment
- Injection or infusion
- How many people
- 46 participants
- Where
- 1 siteFrance
- Study dates
- 1 Feb 2020to 31 Dec 2020
- Phase
- Observational
- 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 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Study population: The study population consisted of adult patients with adenocarcinoma-type gastric non-resectable PC, without metastasis other than peritoneal, treated either with PIPAC administered in alternation with systemic chemotherapy or by systemic chemotherapy alone. All patients receiving PIPAC in our hospital during the study period were included. The patients in the group had been treated during the same period and were carefully selected according to age, general state of health (WHO performance status <3) and absence of extra-peritoneal metastases so as to match as closely as possible the patients in the PIPAC group.
Who may be able to join
- 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
Who cannot join
- Patients opposed
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Effect of Pressurised Intraperitoneal Aerosol Chemotherapy 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.
- Conditions
- Carcinomatosis, Peritoneal
- Being tested
- PIPAC with systemic chemotherapy, Systemic chemotherapy alone
- Medical subject headings
- Peritoneal Neoplasms
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
PIPAC with systemic chemotherapyDrug
PIPAC procedures were performed every 6 to 8 weeks, alternating with systemic chemotherapy, replacing a cycle of intravenous chemotherapy.
Systemic chemotherapy aloneDrug
Intravenous chemotherapy
| Study group | Role | What they receive |
|---|---|---|
| PIPAC CHEM | PIPAC associated with systemic chemotherapy Receives: Drug: PIPAC with systemic chemotherapy | |
| ONLY CHEM | systemic chemotherapy alone Receives: Drug: Systemic chemotherapy alone |
What is being measured
The primary outcome is the main question the study is designed to answer.
Overall survival at 6 months
Overall survival at 6 months from diagnosis of carcinomatosis
Measured: 6 months
Secondary outcomes (2)
Duration of hospital stay
duration of hospitalization up to 6 months after the diagnosis of carcinomatosis
Measured: 6 months
overall survival from the diagnosis of carcinomatosis and from the diagnosis of the primary tumour.
overall survival throughout the study follow-up from the diagnosis of carcinomatosis and from the diagnosis of the primary tumour.
Measured: 3 years
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted10 May 2021
- Study start1 Feb 2020
- Primary completion30 Aug 2020
- Study completion31 Dec 2020
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Carcinomatosis, PeritonealStudies of the same condition, open and under way.
- 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
- Observational
- Observational model
- Other
- Time perspective
- Retrospective
- Enrolment
- 46 participants (actual)
Sponsor and investigators
- Lead sponsor
- Association Francaise de Chirurgie
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Pr Catherine Arvieux, Association Francaise de Chirurgie
- Investigators
- Catherine Arvieux, Principal investigator, Grenoble Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04879953
- Sponsor's protocol ID
- PIPAC
- Status last verified
- May 2021
- First submitted
- 5 May 2021
- Last updated
- 11 May 2021
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 11 May 2021. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Effect of Pressurised Intraperitoneal Aerosol Chemotherapy on the Survival Rate of Patients With Peritoneal Carcinomatosis of Gastric Origin
- ClinicalTrials.gov ID
- NCT04879953
- Acronym / sponsor ID
- PIPAC
- Conditions
- Carcinomatosis, Peritoneal
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 46 participants (actual)
- Lead sponsor
- Association Francaise de ChirurgieUniversity, hospital or other
- Study start
- 1 Feb 2020 (actual)
- Primary completion
- 30 Aug 2020 (actual)
- Study completion
- 31 Dec 2020 (actual)
- First posted
- 10 May 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.
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.
Study design
- Observational model
- Other
- Time perspective
- Retrospective
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| PIPAC CHEM | – | Drug: PIPAC with systemic chemotherapyPIPAC associated with systemic chemotherapy |
| ONLY CHEM | – | Drug: Systemic chemotherapy alonesystemic chemotherapy alone |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- The study population consisted of adult patients with adenocarcinoma-type gastric non-resectable PC, without metastasis other than peritoneal, treated either with PIPAC administered in alternation with systemic chemotherapy or by systemic chemotherapy alone. All patients receiving PIPAC in our hospital during the study period were included. The patients in the group had been treated during the same period and were carefully selected according to age, general state of health (WHO performance status <3) and absence of extra-peritoneal metastases so as to match as closely as possible the patients in the PIPAC group.
Key inclusion criteria (6 listed)
- 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)
Key exclusion criteria (1 listed)
- Patients opposed
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 |
|---|---|---|
| PIPAC with systemic chemotherapyPIPAC procedures were performed every 6 to 8 weeks, alternating with systemic chemotherapy, replacing a cycle of intravenous chemotherapy. | Drug | PIPAC CHEM |
| Systemic chemotherapy aloneIntravenous chemotherapy | Drug | ONLY CHEM |
Primary outcome
Overall survival at 6 months
Time frame: 6 months
Overall survival at 6 months from diagnosis of carcinomatosis
2 secondary outcomes
Duration of hospital stay
Time frame: 6 months
overall survival from the diagnosis of carcinomatosis and from the diagnosis of the primary tumour.
Time frame: 3 years
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 11 May 2021.
Related trials for Carcinomatosis, Peritoneal
RecruitingPhase 1
Individual Response to Hyperthermic Intraperitoneal Chemotherapy (HIPEC) Treatment of Peritoneal Carcinomatosis From Peritoneal Mesothelioma or Atypical Mesothelial Proliferation or From Ovarian, Colorectal, or Appendiceal Histologies
Peritoneal Mesothelioma, Peritoneal Carcinomatosis
RecruitingPhase 1
Intraperitoneal Paclitaxel With NALIRIFOX for Pancreatic Ductal Adenocarcinoma With Peritoneal Carcinomatosis
Pancreatic Ductal Adenocarcinoma (PDAC)
RecruitingPhase 2
Combined Systemic and Intraperitoneal Chemotherapy for Synchronous Gastric and/or Gastroesophageal Peritoneal Carcinomatosis
Synchronous Gastric Peritoneal Carcinomatosis, Gastroesophageal Peritoneal Carcinomatosis
Active, not recruitingPhase 1
Determining the Biodistribution of an Imaging Tracer (68Ga-FAPi-46) in Patients With Solid Tumors or Hematologic Cancers
Anal Carcinoma, Bladder Carcinoma
RecruitingPhase 1
A Study of Mesothelin-Targeted CAR T-Cell Therapy in People With Esophagogastric Cancer or Malignant Peritoneal Mesothelioma
Mesothelin Positive, Mesothelin-Expressing Tumors
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.
Catherine Arvieux principal investigator
Grenoble Hospital
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Carcinomatosis, Peritoneal, run by Association Francaise de Chirurgie 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 6 inclusion and 1 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: finished, as of the sponsor's last update on 11 May 2021. 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. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
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?
Overall survival at 6 months (time frame: 6 months). 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 11 May 2021.